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Background: Plantar warts are a common cutaneous disease of the sole of the foot caused by human papillomavirus. Photodynamic therapy has gained increasing attention in the treatment of plantar warts., Objective: To investigate the effect of photodynamic therapy combined with transfer factor capsules in the treatment of multiple plantar warts., Methods: Sixty-one patients with multiple plantar warts who visited our outpatient department from September 2017 to August 2019 were randomly divided into two groups. Twenty-three patients received photodynamic therapy (treatment group) and thirty-eight received cryotherapy (control group). Both groups also received immune modulator transfer factor capsules. Skin lesion score, numeric rating scale- (NRS-) 10 score, recurrence rate, adverse reactions, and Dermatology Life Quality Index (DLQI) were analyzed in both groups., Results: The mean skin lesion score improved from 13.39 ± 3.88 before treatment to 1.48 ± 2.50 after the last treatment in the treatment group and from 12.47 ± 2.99 before treatment to 4.47 ± 3.67 after the last treatment in the control group. The success rate after 3 months of treatment was 86.96% in the treatment group and 39.47% in the control group. After 3 months of follow-up, the recurrence rate was significantly lower in the treatment group (20%) than in the control group (53.33%). The mean DLQI score at three months after treatment was significantly lower in the treatment group (3.61 ± 1.16) than in the control group (6.31 ± 2.59)., Conclusion: Photodynamic therapy combined with immunomodulators significantly increased the cure rate and reduced the recurrence rate of multiple plantar warts compared with traditional cryotherapy combined with immunomodulators., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2022 Chen Wu et al.)

Covid-19 or SARS-CoV-2, a new RNA virus with high infectivity, and seemingly low mutability, which appeared in 2019 in the Wuhan province of China, has created a pandemic with dire consequences. At the end of May 2020, it became the first cause of mortality. As no treatment or vaccine may become available before many months, and because occurrence of similar pandemics is only a matter of time, arguments are presented here for testing the effect of transfer factor (TF), an immunomodulator devoid of toxicity, which has been extensively studied in the past for the treatment and prevention of viral infections.

Immunomodulatory agents have been proposed as therapeutic candidates to improve outcomes in sepsis. Transferon™, a dialyzable leukocyte extract (DLE), has been supported in Mexico as an immunomodulatory adjuvant in anti-infectious therapy. Here we present a retrospective study describing the experience of a referral pediatric intensive care unit (PICU) with Transferon™ in sepsis. We studied clinical and laboratory data from 123 patients with sepsis (15 in the DLE group and 108 in the control group) that were admitted to PICU during the period between January 2010 and December 2016. Transferon™ DLE use was associated with lower C reactive protein (CRP), increase in total lymphocyte counts (TLC), and decrease in total neutrophil count (TNC) 72 hours after Transferon™ DLE administration. The control group did not present any significant difference in CRP values and had lower TLC after 72 hours of admission. There was no difference in PICU length of stay between control and Transferon™ DLE group. Transferon™ DLE administration was associated with a higher survival rate at the end of PICU stay. This study shows a possible immunomodulatory effect of Transferon™ on pediatric sepsis patients.

Transferon® is an immunomodulator made of a complex mixture of peptides from human dialyzable leucocyte extracts (hDLEs). Development of surrogate antibodies directed to hDLE is an indispensable tool for studies during process control and preclinical trials. These antibodies are fundamental for different analytical approaches, such as identity test and drug quantitation, as well as to characterize its pharmacokinetic and mechanisms of action. A previous murine study showed the inability of the peptides of Transferon® to induce antibody production by themselves; therefore, in this work, two approaches were tested to increase its immunogenicity: chemical conjugation of the peptides of Transferon® to carrier proteins and the use of a rabbit model. Bioconjugates were generated with Keyhole Limpet Hemocyanin (KLH) or Bovine Serum Albumin (BSA) through maleimide-activated carrier proteins. BALB/c mice and New Zealand rabbits were immunized with Transferon® conjugated to KLH or nonconjugated Transferon®. Animals that were immunized with conjugated Transferon® showed significant production of antibodies as evinced by the recognition of Transferon®-BSA conjugate in ELISA assays. Moreover, rabbits showed higher antibody titers when compared with mice. Neither mouse nor rabbits developed antibodies when immunized with nonconjugated Transferon®. Interestingly, rabbit antibodies were able to partially block IL-2 production in Jurkat cells after costimulation with Transferon®. In conclusion, it is feasible to elicit specific and functional antibodies anti-hDLE with different potential uses during the life cycle of the product.

Background: Dialyzable leukocyte extracts (DLE) have been used to treat several cellular immunodeficiency., Objective: To review the experience of a tertiary hospital in the use of DLE for the treatment of recurrent or severe infections in children with acquired cellular immunodeficiency not due to HIV., Methods: We reviewed the medical records of all children who received treatment with EDL of human or bovine origin between 1986 and 2000 to detect recurrent or severe infections without response to a specific antimicrobial therapy and with a quantitative or qualitative deficit in the cellular immune response. The dose of DLE was adjusted according to the percentage of T lymphocytes; the evolution of the patient was evaluated retrospectively for 5 years, the immune response was evaluated by subpopulation of lymphocytes and intradermal tests and inhibition of the leukocyte migration assay (LIF) to PPD, coccidioidin, varidase and candidin., Results: 150 children received DLE, age 7.0 ± 5.9 years. The most frequent indications included upper respiratory tract (71%), lower respiratory tract (43%), gastrointestinal tract (15%), urinary tract (15%) and neurological infections (4%) and coccidioidomycosis (3%). After starting the DLE, the numbers of T lymphocytes, LIF to PPD and varidase (> 20%) and the intradermal induration of the test increased (p <0.001). In 6 patients (4%) recurrences of respiratory and gastrointestinal tract infections were observed, which resolved, no adverse effects attributable to the DLE were reported., Conclusions: The use of DLE for recurrent or severe infectious processes in children with cellular immune deficit improved the clinical evolution and the immunological parameters evaluated without adverse effects attributable to their use.

Metacestode (larval) stages of zoonotic cestodes of medical and veterinary importance cause chronic infections associated with immunosuppression. During mouse model of cestode infection induced by larvae of Mesocestoides (M.) vogae, we investigated the effects of dialyzable leukocyte extract (DLE) containing low-molecular weight substances (under 10 kDa) prepared from peripheral blood leukocytes of healthy human donors (available under commercial name IMMODIN). In the experiment, the effects of DLE as adjuvant to anthelmintic albendazole (ABZ) as well ABZ mono-therapy were also investigated. We showed that DLE enhanced therapeutic effect of ABZ by significant reduction of parasites number in both biased sites. Furthermore, administration of DLE reduced fibrosis and concentrations of lipid peroxides in the liver and thereby showed cytoprotective effect. In contrast, higher hydroxyproline level and numbers of larvae enclosed in fibrous capsules were found in ABZ-treated group. In order to investigate whether DLE could affect parasite-induced immunosuppression, we evaluated selected immune parameters. The results showed that DLE administration to mice increased proliferation of concanavalin A stimulated splenic cells ex vivo. Similarly, in vitro study confirmed that DLE ameliorated hypo-responsiveness of T lymphocytes and partially reverted suppressive effect of parasites excretory-secretory products. In addition, flow cytometric analysis revealed higher numbers of T helper and NK cells in the spleen and peritoneal cavity of infected mice after DLE + ABZ therapy. We also found strongly reduced serum levels of TGF-β1 and IL-17 as well as modulation of cytokines associated with Th1/Th2 immunity. These results suggest that IMMODIN could serve as a suitable adjuvant to the primary anthelmintic therapy., (Copyright © 2018. Published by Elsevier B.V.)

Prostate cancer (PCa) is the second most frequently diagnosed cancer in men worldwide. Dialyzed Leukocyte Extracts (DLEs) are heterogeneous mixtures of low-molecular-weight peptides that improve clinical responses in various diseases. Here, we analyzed the effects of Transferon TM , a commercial DLE with characterized active pharmaceutical ingredient and proven batch-to-batch reproducibility, in preclinical models of PCa. We employed v-Src-transformed murine prostate epithelial (PEC-Src) cells, which recapitulate the transcriptional profiles in human PCa, can be grown in immunocompetent mice, and consistently form bone and brain metastases. In vitro, Transferon TM did not induce cytotoxicity nor alterations in migration /invasion of PEC-Src cells. In vivo, Transferon TM reduced metastatic dissemination after intracardiac injection of PEC-Src and inhibited tumor growth of subcutaneous isotransplants. The antineoplastic effect of Transferon TM correlated with changes in tumor infiltration, increased serum concentrations of IL-12 and CXCL1, and reduced levels of VEGF. Our results suggest that the antineoplastic effect produced by Transferon TM is due to its immunomodulatory activity and not by a direct effect on cancer cells, and indicate that Transferon TM could be beneficial as adjuvant therapy in PCa patients., (Copyright © 2018 The Authors. Published by Elsevier Masson SAS.. All rights reserved.)

Background: Dialyzable leukocyte extracts (DLEs) contain molecules smaller than 10 kDa with biological activity in receptor organisms. Primarily, they participate in the regulation of the Th1 immune response, which is essential for the control of several intracellular infections, such as toxoplasmosis. This disease is associated with congenital infection, encephalitis or systemic infections in immunocompromised individuals. The clinical course of this infection fundamentally depends on a well-regulated immune response and timely treatment with the appropriate drugs., Objective: The aim of this study was to evaluate the effect of treatment with a leukocyte extract, derived from crocodile lymphoid tissue, on the histopathology and brain parasite load in NIH mice that had been infected with cysts of Toxoplasma gondii (ME-49 strain)., Methods: The treatment was applied during the acute and chronic stages of the infection. Histopathological changes were evaluated in the ileum, liver and spleen at one, four and eight weeks after infection and in the brain at week 8. The parasite load was evaluated by counting the cysts of T. gondii found in the brain., Findings: Compared to the control mouse group, the mice infected with T. gondii and under treatment with DLE showed less tissue damage, mainly at the intestinal, splenic and hepatic levels. In addition, a greater percentage of survival was observed, and there was a considerable reduction in the parasite load in the brain., Conclusions: The results suggest that DLE derived from crocodile is a potential adjunctive therapy in the conventional treatment of toxoplasmosis.

The objective of the study was to assess the clinical, histopathological and immunochemical changes induced by dialyzable leukocyte extract (DLE) treatment in patients with chronic cervicitis associated to HPV infection. Fifty-four female Mexican patients diagnosed with chronic cervicitis, cervical intra-epithelial neoplasia grade 1 (CIN 1) and HPV infection were divided into two groups: patients treated with placebo and patients treated with DLE. Clinical and colposcopy evaluations were performed before and after treatments. Cervix biopsies were obtained to analyze histopathological features and to determine the local immunological changes by immunohistochemistry analyses. Placebo-treated patients showed no significant changes in the evaluated parameters. Interestingly, in DLE-treated patients, clinical manifestations of cervicitis diminished and 89% of them remitted the colposcopic lesions. Histological analyses of biopsies from DLE-treated patients showed a decreasing leukocyte infiltrate. Immunochemical analyses showed an increased expression of TGF-β, while expression of IFN-γ, PCNA, and IL-32 decreased. Our results suggest that DLE can stimulate innate immunity of cervical mucosae, diminishing chronic cervicitis in HPV-infected patients., Trial Registration: Register ISRCTN16429164 Abbreviations: HPV = Human Papilloma Virus; DLE = Dialyzable leukocyte extract.

Objective: to evaluate the action of Transfer Factor on the immune response of patients with malignant neoplasm submitted to surgery, chemotherapy and radiotherapy., Method: we analyzed the variations of leukocytes, total lymphocytes, T-lymphocytes and CD4 counts in 60 patients submitted to immunostimulation with a single, daily dose of 0.5mg sublingual Transfer Factor, started simultaneously with chemotherapy and/or radiotherapy., Results: there were statistically significant increases in the counts of all cell lines studied, more pronounced after 12 months of use of the medication., Conclusion: the Transfer Factor restored immune response and showed no side effects.

Objectives: To evaluate the effect of dialysable leucocyte extract (DLE) on pro- and anti-inflammatory profiles in a rat model of osteoarthritis (OA)., Method: Forty-eight male Wistar rats were divided into three groups: normal rats without treatment, OA rats treated with placebo, and OA rats treated with DLE. After treatment, the animals were killed to obtain cartilage for histological analysis and to determine the expression of pro- and anti-inflammatory cytokines by reverse transcription multiplex polymerase chain reaction (RT-MPCR) and immunohistofluorescence analyses., Results: Histological analysis revealed that OA cartilage from rats treated with DLE displayed similar characteristics to non-OA cartilage from the control group. The OA cartilage treated with placebo showed alterations in the cellular architecture and in chondrocyte cluster formation. Analysis of cytokine expression by RT-MPCR showed that OA cartilage from DLE-treated rats expressed platelet-derived growth factor (PDGF), interferon (IFN)-γ, and fibroblast growth factor (FGF)-2, similar to non-OA cartilage from the control group. However, OA cartilage from rats treated with placebo expressed interleukin (IL)-1, PDGF, and I kappa B (IκB). Confocal immunodetection of FGF-2, PDGF, and non-phosphorylated IκB showed that they were distributed in the cytoplasm of most chondrocytes in OA cartilage from DLE-treated rats whereas no nuclear factor kappa B (NF-κB) expression was observed in the nuclei. Instead, in OA cartilage from the placebo group, only weak FGF-2 staining was observed, PDGF and IκB were not detected, and NF-κB was strongly observed in both cytoplasm and nuclei., Conclusions: Our findings suggest that DLE treatment modifies the OA process, promoting the expression of anti-inflammatory cytokines and diminishing the inflammatory effects, avoiding the nuclear translocation of NF-κB in chondrocytes.

Transfer factor (TF) is a low-molecular-weight lymphocyte extract capable of transferring antigen-specific cell-mediated immunity (CMI) to T lymphocytes. It has been used successfully as an adjuvant or primary therapy for viral, parasitic, fungal, and some bacterial infections, as well as immunodeficiencies, neoplasias, allergies and autoimmune diseases. From the list of infections that seem to respond noticeably to transfer factor, those due to viruses of the herpes family are particularly remarkable. Indeed, for these viruses it was shown that TF can prevent infection or relapse, acting as a CMI vaccine. Data also suggest its possible use for adjuvant treatment and probably prevention of two currently widespread infections: tuberculosis and AIDS. Furthermore, TF has an interesting potential: answering the challenge from unknown pathogenic agents, a black box effect permitting production of antigen-specific TF to a new pathogen, even before its identification. It thus seems that the preventative potential of transfer factor is as important as its therapeutic one, both discussed in this review.

Background: Infection is one of the most common complications and still remains a significant cause of morbidity and occasionally mortality in patients, especially children with nephrotic syndrome. Many different prophylactic interventions have been used or recommended for reducing the risks of infection in nephrotic syndrome in clinical practice. Whether the existing evidence is scientifically rigorous and which prophylactic intervention can be recommended for routine use based on the current evidence is still unknown., Objectives: To assess the benefits and harms of any prophylactic intervention for reducing the risk of infection in children and adults with nephrotic syndrome., Search Methods: We searched the Cochrane Renal Group's specialised register, the Cochrane Central Register of Controlled Trials (CENTRAL) (in The Cochrane Library), MEDLINE and Pre-MEDLINE (from 1966), EMBASE (from 1980), China Biological Medicine Database (1979 to December 2009), Chinese Science and Technique Journals Database (to December 2009), China National Infrastructure (to December 2009), WangFang database (to December 2009), reference lists of nephrology textbooks, review articles, relevant studies and abstracts from nephrology meetings without language restriction.Date of last search: 6 February 2012, Selection Criteria: Randomised controlled trials (RCTs) and quasi-RCTs comparing any prophylactic interventions (pharmacological or non-pharmacological) for preventing any infection in children and adults with nephrotic syndrome., Data Collection and Analysis: Two authors independently assessed and extracted information. Information was collected on methods, participants, interventions and outcomes (appearance of infection, mortality, quality of life and adverse events). Results were expressed as risk ratios (RR) for dichotomous outcomes or as mean differences (MD) for continuous data with 95% confidence intervals (CI)., Main Results: Twelve studies conducted in China, including 762 children with nephrotic syndrome were identified. No studies were identified in adults. All studies compared one kind of prophylactic pharmacotherapy (intravenous immunoglobulin (IVIG), thymosin, oral transfer factor, mannan peptide tablet, Bacillus Calmette-Guerin (BCG) vaccine injection, polyvalent bacterial vaccine (Lantigen B) and two kinds of Chinese medicinal herbs: a compound of Chinese medicinal herbs (TIAOJINING) and Huangqi (astragalus) granules) plus baseline treatment with baseline treatment alone. No RCTs were identified comparing antibiotics, non-pharmacological prophylaxis, or pneumococcal vaccination. Four studies showed a significantly beneficial effect of IVIG on preventing nosocomial or unspecified infection in children with nephrotic syndrome (RR 0.47, 95% CI 0.31 to 0.73). Thymosin (RR 0.50, 95% CI 0.26 to 0.97), oral transfer factor (RR 0.51, 95% CI 0.35 to 0.73), BCG vaccine injection (RR 0.68, 95% CI 0.48 to 0.95), Huangqi granules (RR 0.62, 95% CI 0.47 to 0.83) and TIAOJINING (RR 0.59, 95% CI 0.43 to 0.81) were also effective in reducing the risk of infection in children with nephrotic syndrome. However mannan peptide tablet (RR 0.46, 95% CI 0.21 to 1.01) and polyvalent bacterial vaccine (RR 0.24, 95% CI 0.06 to1.00) were not superior to baseline treatment in reducing the risk of infection for nephrotic children. No serious adverse events were reported., Authors' Conclusions: IVIG, thymosin, oral transfer factor, BCG vaccine, Huangqi granules and TIAOJINING may have positive effects on the prevention of nosocomial or unspecified infection with no obvious serious adverse events in children with nephrotic syndrome. However the methodological quality of all studies was poor, the sample sizes small, and all studies were from China, and thus there is no strong evidence on the effectiveness of these interventions.

Transfer factor (TF) consists of messenger peptides produced by activated T lymphocytes as part of cellular immunity, and it acts in virgin lymphocytes through TF inducers, suppressors and specific antigens. TF is not immunogenic because it is not species-specific, since it contains a consensus sequence of amino acids LLYAQDL/VEDN. TF extracted from leukocytes can transfer immunity from a human to another species. TF extracts are complex, containing more than 200 molecules with molecular weights ranging from 1 to 20 kDa. The antigen specific transfer factors (STF) have molecular weights between 3,5 and 5 kDa. TF is easy to prepare and well tolerated. It does not contain HL-A antigens against potential receptors and it can used as adjuvant therapy in several diseases., (Copyright © 2010 Elsevier España, S.L. All rights reserved.)

Background: Skin cancers are common, and there has recently been a dramatic increase in their incidence, particularly in the occurrence of melanoma. Furthermore, relapse after curative surgical treatment of melanoma remains a significant clinical challenge and accounts for most of the mortality of this disease., Objective: The aim of this study was to determine whether IMMUNEPOTENT CRP affects B16F10 melanoma cells and tumors growth and vascular endothelial growth factor (VEGF) production in vivo and in vitro., Methods: B16F10 cells and B16F10-inoculated mice were treated with different concentrations of IMMUNEPOTENT CRP. Outcomes were then evaluated using MTT, TUNEL, Caspase-3, senescence, ELISA and colorimetric assays. Parameters related to survival and tumor weight were also assessed., Results: IMMUNEPOTENT CRP decreased the viability of B16F10 cells by increasing apoptosis of the treated cells, and VEGF production was decreased both in vitro and in vivo. Furthermore, treatment prevented metastasis, delayed the appearance of tumors, decreased tumor weight and improved the survival of tumor-bearing mice., Discussion: These observations suggest that IMMUNEPOTENT CRP can be used to suppress growth and metastasis by using targeting proteins such as VEGF.

The effect of dialysable leucocyte extract (transfer factor TF) on immune response of mice infected with Echinococcus multilocularis and treated with albendazole (ABZ) was observed. TF administration increased the parasite-suppressed proliferative response of T and B lymphocytes of infected mice from weeks 8 to 12 or 14 post infection (p.i.), respectively, with the most stimulative effect after TF+ABZ therapy. The CD4 T cell presence in the spleen of infected mice with TF or TF+ABZ therapy was increased from weeks 6 to 12 or 14 p.i., respectively. The production of IFN-gamma (Th1 cytokine) after TF or TF+ABZ therapy was significantly higher from weeks 6 to 12 p.i., and during this time, the significantly inhibited IL-5 synthesis (Th2 cytokine) was detected, particularly after TF+ABZ therapy. The superoxide anion (O2-) production in peritoneal macrophages of infected mice treated with TF or TF+ABZ was stimulated from weeks 8 to 18 p.i. The immunomodulative effect of TF reduced the growth of larval cysts till week 14 p.i. with a comparable intensity to the anthelmintic drug ABZ. Combined therapy TF+ABZ resulted in the greatest parasite restriction and reduced the cyst development till the end of the experiment.

Background: Inhaled glucocorticoids are the most effective and potent drugs used to control the inflammatory bronchial reaction in patients with asthma. There are several research projects evaluating the use of immune modulators in the treatment of the asthma related inflammatory process., Objective: To evaluate the effect of transfer factor in the treatment of pediatric patients with moderate persistent allergic asthma in terms of inhaled glucocorticoid dosing and time of using., Patients and Methods: Randomized, double blind, placebo controlled pilot clinical trial in a cohort of pediatric patients (6-17 years old) with moderate persistent allergic asthma. Two groups were formed. Group one received transfer factor and group two was given placebo. Both groups received conventional therapy with inhaled budesonide and formoterol. Daily respiratory symptoms (cough during day, or at night, and wheezing episodes) were recorded in a personal diary. Spirometric evaluations were performed before enrolling patients, and at 1, 3 and 6 months after., Results: Eleven patients were enrolled in each group. Patients in the transfer factor group showed a statistical significant reduction in the inhaled glucocorticoid doping since month 3, and this difference was maintained until the end of study. Patients on TF group showed also a non statistical significant improvement in spirometrical findings and also showed a better asthma control., Conclusions: Transfer factor helps to reduce inhaled glucocorticoids dose in patients with allergic rhinitis; however, studies with a larger number of patients should be done in order to obtain better results.

Whipple's disease is an infrequent multisystemic infection caused by a gram-positive bacterium: Tropheryma whippelii, which after several studies has been characterized as an actinomiceto por 16Sr RNA. It occurs with multiple symptoms, the principal of which are diarrhea, weight loss, stomach pain and arthralgias. Arthritis or artralgia may appear as an isolated symptom and eventually through the years additional digestive, cardiovascular and/or neurological symptoms arise. Diverse immunological abnormalities usually present before or after clinical symptoms are first discovered. Currently there are cabinet, endoscopic, radiological, tomographic and laboratory studies which can help to make a definitive diagnosis, such as the duodenal biopsy submitted to the Schiff test, to the polimerasa chain or an electronic microscopy in order to see the intracellular bacteria in the macrophage and for immunohistochemistry to see specific antibodies to Whipple's disease. Treatment is trimetoprim/sulfametoxazol, it is suggested transfer factor too.

The transfer factor (TF) was described in 1955 by S. Lawrence. In 1992 Kirkpatrick characterized the specific TF at molecular level. The TF is constituted by a group of numerous molecules, of low molecular weight, from 1.0 to 6.0 kDa. The 5 kDa fraction corresponds to the TF specific to antigens. There are a number of publications about the clinical indications of the TF for diverse diseases, in particular those where the cellular immune response is compromised or in those where there is a deficient regulation of the immune response. In this article we present our clinical and basic experiences, especially regarding the indications, usage and dosage of the TF. Our group demonstrated that the TF increases the expression of IFN-gamma and RANTES, while decreases the expression of osteopontine. Using animal models we have worked with M. tuberculosis, and with a model of glioma with good therapeutic results. In the clinical setting we have worked with herpes zoster, herpes simplex type I, herpetic keratitis, atopic dermatitis, osteosarcoma, tuberculosis, asthma, post-herpetic neuritis, anergic coccidioidomycosis, leishmaniasis, toxoplasmosis, mucocutaneous candidiasis, pediatric infections produced by diverse pathogen germs, sinusitis, pharyngitis, and otits media. All of these diseases were studied through protocols which main goals were to study the therapeutic effects of the TF, and to establish in a systematic way diverse dosage schema and time for treatment to guide the prescription of the TF.

Glioblastoma multiform (GBM) is the most common tumour of the central nervous system in humans. Unfortunately its prognosis is poor and because of the lack of efficacious therapies, immunotherapy is a potential treatment. Transfer factors (TF) are low molecular weight dialysable products extracted from immune cells which transmit the ability to express delayed-type hypersensitivity and cell mediated immunity from sensitized donors to nonimmnune recipients. In this study, we determined the efficacy of TF as immunotherapy to treat experimental glioblastoma. We used TF obtained from immunized swine. We evaluated different doses of intratumoral TF (product of 4x10(6), 8x10(5) and 1.6x10(5) cells). The best dose (product of 4x10(6) cells) of TF was also combined with carmustine for experimental therapy in rats with C6 malignant glioma. Modifications in peripheral blood T lymphocyte counts ( CD2+, CD4+, CD8+ and NK) were evaluated by flow cytometry. Cytokine expression in the tumour was assessed by RT-PCR and apoptosis was evaluated using the sub G0 method. Intratumoral TF reduced significantly the tumour size, and increased CD2+, CD4+, CD8+ and NK cell counts, it also increased the percentage of apoptotic tumour cells and the percentage of tumour tissue expressing Th1 cytokines. We observed an additive antitumoral effect when TF was combined with chemotherapy.

Background: Atopic dermatitis is a skin inflammatory disease which has been associated to high levels of IgE, eosinophiles and change of T lymphocytes. The transfer factor is an immunomodulator active substance and decreases the number of inflammatory cells and the severity of the symptoms of atopic dermatitis., Objective: To determine the efficacy of the transfer factor as treatment of moderate and severe atopic dermatitis., Material and Methods: Articles related to treatment with transfer factor in the atopic dermatitis were looked up in Medline and EMBASE, and the ones referring to controlled studies in patients with moderate and severe atopic dermatitis in accord to SCORAD., Results: We found seven articles with 121 patients and 88 controls demonstrating significant decrease in the symptoms of the SCORAD index, decreased IgE, and eosinophils in patients treated with transfer factor., Conclusions: The transfer factor is a choice treatment for moderate and severe atopic dermatitis.

The pathophysiology of endotoxic shock is characterized by the activation of multiple pro-inflammatory genes and their products which initiate the inflammatory process. Endotoxic shock is a serious condition with high mortality. Bovine dialyzable leukocyte extract (bDLE) is a dialyzate of a heterogeneous mixture of low molecular weight substances released from disintegrated leukocytes of the blood or lymphoid tissue obtained from homogenized bovine spleen. bDLE is clinically effective for a broad spectrum of diseases. To determine whether bDLE improves survival and modulates the expression of pro-inflammatory cytokine genes in LPS-induced, murine endotoxic shock, Balb/C mice were treated with bDLE (1 U) after pretreatment with LPS (17 mg/kg). The bDLE improved survival (90%), suppressed IL-10 and IL-6, and decreased IL-1beta, TNF-alpha, and IL-12p40 mRNA expression; and decreased the production of IL-10 (P<0.01), TNF-alpha (P<0.01), and IL-6 (P<0.01) in LPS-induced, murine endotoxic shock. Our results demonstrate that bDLE leads to improved survival in LPS-induced endotoxic shock in mice, modulating the pro-inflammatory cytokine gene expression, suggesting that bDLE is an effective therapeutic agent for inflammatory illnesses associated with an unbalanced expression of pro-inflammatory cytokine genes such as in endotoxic shock, rheumatic arthritis and other diseases.

Background: Atopic dermatitis is a skin inflammatory disease, which is associated to high levels of IgE, eosinophiles and change of T lymphocytes., Objective: To determine if the treatment with transfer factor for moderate atopic dermatitis decreases the number of inflammatory cells in the peripheral blood., Material and Methods: We selected twenty patients with diagnosis of moderate atopic dermatitis. The age range of the patients was between 5 and 45 years old. Patients were assigned to one of three groups: group A included patients with atopic dermatitis treated with transfer factor: one unit a day for five days, two units a week, one unit a week, one unit every fifteen days and one unit a month. Group B included ten patients with atopic dermatitis who received conventional treatment (hydroxyzine 10 mg/24 h) and the group C was conformed by healthy controls. All patients were submitted to basal and final determination of IgE, peripheral blood eosinophils, and underpopulation of lymphocytes by flow cytometry. Study period was of ten weeks., Results: Levels of IgE were reduced respect to the basal value. In the patients of group A there was an increase in neutrophils and leukocytes after treatment; however, it was not significant (p = 0.46). Eosinophils were significantly reduced (p = 0.01). After comparing group A to group C the p value was of 0.035., Conclusion: In patients with atopic dermatitis, after 10 weeks of treatment with transfer factor, the level of IgE and peripheral eosinophils was reduced.

A case with common variable immunodeficiency associated to hyperprolactinaemia and severe damage of mucosal defenses is reported, in which humoral and cellular response was widely explored. The impact of the cytokines therapy was analyzed as complementary schedule to the conventional therapy with gammaglobuline. Immune response to the treatment was long-time evaluated in relation with therapeutic interventions. Combination of alpha 2 b-IFN, thymic factors, gammaglobuline and GM-CSF was a good alternative to treat complicated common variable immunodeficiency.

Background: The atopic dermatitis is a chronic disease with immunological alterations, neuro-immune-endocrine implications and repercussions in the psyche., Objective: To determine the effectiveness of the use of psychological support in the treatment of atopic dermatitis., Material and Methods: This study included 20 patients (from 15 to 50 years old) with moderated and severe atopic dermatitis based on the Hanifin and Rafka modified criteria. They were classified in three groups of treatment: A) 10 patients with transfer factor and psychological support, B) 10 with transference factor without psychological support, C) 10 healthy individuals as a control group. At the beginning and ending of the analysis the degree of severity of the illness was determined using the SCORAD scale., Results: There was a more statistically significant clinical improvement on group A than in group B, besides a decrease in anxiety and depression, at a laboratory level including hormonal behavior, without meaningful changes., Conclusions: It was demonstrated that the treatment with immune-modulator and psychological support on the moderated and severe atopic dermatitis improves the clinical and immunological evolution of this illness.

Wegener's granulomatosis is a form of systemic vasculitis of unknown etiology that affects the small blood vessels. The disease is characterized by the formation of granulomas on small and medium blood vessels, and often affects the respiratory tract and renal system. In 86% of diagnosed cases, renal compromise is in the form of glomerulonephritis. Wegener's granulomatosis can occur at any age, principally during the 4th and 5th decades of life, and 85% of cases occur over the age of 19 years. In the United States about 3 per 100,000 cases are reported, with a major occurrence in males. The present report is about a case of a 12 year old female with Wegener's granulomatosis of 18 months of evolution, with symptoms such as epistaxis, generalized edema, cough, dyspnea, hemoptysis, high blood pressure and macroscopic hematuria. Out of the five criteria for the diagnosis of Wegener's granulomatosis, she had perinuclear anti-neutrophil cytoplasmic antibody positive to serum p-ANCA mark, which is the least frequent, which makes more difficult the diagnosis. Over a period of five years, in our hospital, we have diagnosed 11 patients with Wegener's granulomatosis, and the present case is the only pediatric case.

Background: Atopic dermatitis is an inflammatory dysfunction in whose physiopathology the lymphocytes T play an important role in the regulation of the inflammatory process., Objective: To determine and to characterize the role of apoptosis of lymphocytes in patients with moderate to severe atopic dermatitis before and after treatment with transfer factor., Material and Methods: Fifteen patients with moderate to severe atopic dermatitis in a range of age from 5 to 45 were included in the study. Fifteen healthy subjects were taken as a control group. In all subjects it was determined the apoptosis of the lymphocytes by means of annexin and TUNEL techniques, as well as the expression of CD95 cells. The 15 patients with atopic dermatitis received treatment with transfer factor in stepped dose as follows: 1 U/day/5 doses, 1 U/week/3 doses, 1 U/15 days/2 doses, 1 U/30 days, until completing three months. At the end of this period new determinations were done to measure apoptosis of lymphocytes and PMN. At the beginning and at the end assessments of the severity in relation to the scale SCORAD were made., Results: By means of both techniques no significant difference was found in the percentage of apoptotic lymphocytes between patients and control subjects. Differences of the expression of CD95 between patients and control subjects before and after treatment were not significant. There was a significant difference (p < 0.01) of severity from the beginning to the end of treatment with transfer factor in patients with atopic dermatitis., Conclusion: No significant differences of apoptosis of lymphocytes were found in patients with atopic dermatitis who received treatment and control subjects, neither before not after the treatment with transfer factor. It was verified the decrease in the severity of the symptoms related to the treatment with transfer factor.

Objective: To observe the changes of immune function in children with acute Henoch-Schonlein purpura (AHSP) and the effects of integrated traditional Chinese and western medicine (TCM-WM) on it., Methods: Immunological criteria in TCM-WM group (n = 35) treated by Yinfu Decoction (YFD) combined with transfer factor and 35 patients in the control group (n = 35) treated by conventional treatment were observed and compared before and after treatment. Also the criteria were compared with those of 40 healthy subjects., Results: Before treatment, the levels of IgA, IgM, CD4, CD4/CD8 ratio, rosette forming rate of RBC-C3b receptor in patients were higher than those in the healthy subjects, but the levels of CD8 was obviously lower, the difference was significant (P < 0.01). The above-mentioned criteria were all improved in the two treated groups after treatment, and the improvement was more significant in the TCM-WM group than that in the control group (P < 0.05). Besides, the cure-markedly effective rate in the former was better than that in the latter significantly (P < 0.01)., Conclusion: There exist multiple immune functional disturbance in AHSP patients. Combined treatment of YFD and transfer factor has obvious immune regulatory effect and is an effective therapy with few side-effects and low recurrence rate.

Aims: The atopic dermatitis is an chronic inflammatory illness of the skin. It exists an interrelation complex of factors gene, environmental, and psychological that contribute to the development and severity of the illness. The immunol aberrations significant is the answer increased of IgE specific antibodies toward antigens common, the liberation is increased of immunol mediators by the basophils and mast cells, eosinophils peripheral and local, besides enlarges the biphasic activity Th1/Th2 with liberation of cytokines (IL-4, IL-5, IL-13), GM-C5F, and decrease of IFN-gamma by the cells Th1. Leung to report a knowledge upon the bases immunopathologies of it atopic dermatitis has immunopathologies clinical important for the diagnosis and processing. Alternatives multiples of processing by the same complexity of the illness exist., Objective: To compare the security and the clinical efficacy of the thalidomide and the factor of transfer in the atopic dermatitis severe., Material and Method: Were studied patient with diagnosis of atopic dermatitis severe in agreement with the criterions of Hanifin and Rajka that they entered to the service of Allergy and Immunology Clinical of the Hospital Regional Lic. Adolfo López Mateos (public hospital). They were included 19 patient (women 12 and men 7, with age average 30 +/- 4 years). They were distributed in two groups. The first group of 5 patient administration thalidomide 200 mg/d during six months. The second group am administered the factor of transfer a total of 15 units by road oral during six months. Studies of laboratory for appraisal were requested immunology and metabolic pretreatment and pretreatment., Results: In the group A dealt with thalidomide 5 patient and the group B dealt with FT, both presented a statistically significant decrease, as for the extension of the wounds (p < 0.01), and 1 am observed greater reduction in the intensity of the symptoms, the SCORAD total (p < 0.001 and p < 0.001 respectively) with statistical difference among them. None presented alterations immunologies and metabolic secondary to the use of the two drugs and not there was the need to suspend the processing. During the period of study, the patient were maintained controlled to the allergic rhinitis and the asthma., Discussion: In the atopic dermatitis by its secondary clinical complexity to the multifactors etiologic, the alternatives of processing utilized in the present study are an option the security and efficacy, I am observed better clinical.

The atopic dermatitis is a chronic inflammatory skin illness, with remissions and exacerbations, itch, and association with allergic rhinitis and asthma. There is a complex interrelationship of genetic, environmental, pharmacological and psychological factors that contribute to the development and severity of the illness: Different manifestations of immunological disorders are an increment in the number of IgE antibodies toward common antigens, an increment in the liberation of proinflammatory mediators by basophils and mast cells, peripheral and local eosinophilia, biphasic activity Th1/Th2 with the liberation of cytokines (IL-4, IL-5, IL-13), GM-CSF and the IFN-gamma caused by the cells Th1. an increment in the liberation of major basic protein, eosinophil cationic protein besides the expression of chemotactic factors by the monocytes (RANTES, eotaxin, vasoactive intestinal peptide, etc.). In 1980, Hanifin and Rajka made public the diagnostic criteria for the atopic dermatitis and it has been universally accepted as an standard for the diagnosis. Leung reported that a knowledge about the immunopathological bases of the atopic dermatitis has important clinical implications for the diagnosis and possible treatment there are multiple choices for a treatment because of the complexity of the illness. Among these are thalidomide and transfer factor as an immunomodulator treatment with acceptable safety and clinical efficacy.

Background: The atopic dermatitis is a chronic skin disease that appears in patients with a personal or family history of allergic asthma and rhinitis. It is associated to the specific activation of a gene group. In most instances, the response to the conventional treatment is adequate. The are cases, though, know as refractory, where that is not the case. The study of two therapeutic alternatives, Transfer Factor (TF) and Cyclosporin A (CyA), was elaborated for this type of patients., Material and Methods: Patients with severe refractory AD were studied, being admitted to the Allergic Service to the ISSSTE Lic. Adolfo López Mateos, ISSSTE, between September 1997 and june 1998. They were randomly divided in two groups. The first one was subjected to CyA, on a 4 mg/kg/day dosage, with monthly surveillance of kidney and hepatic functions and blood pressure twice a week. Group two was subjected to TF, as follows: one unit every third day for the first week, two units per week for the next three weeks and one monthly unit to complete six months. Initial and final clinical and immunologic testing was performed on both groups (eosinophils, total IgE, CD4 and CD8)., Results: Six patients included group A, and 12 patients in group B. Both groups showed a significant statistic reduction in the total eosinophils count, without an statistic difference between them. None showed changes in the total IgE. CyA reduced the CD4 levels, while the TF increased the levels of CD8 cells, both with a p < 0.05. Both groups showed clinical improvement satistically significant, but no differences with a p > 0.05 appeared between them. Tolerance to the treatments was adequate, and there was not need to suspend the treatment in any case. Only three patients showed hypertricosis and other one presented headaches, with CyA., Conclusion: Both treatments showed therapeutic benefits in the treatment of patients with severe refractory AD, with similar immunologic improvement. Both drugs present different action mechanisms, so their joint application could offer clinical benefit to the patient (synergetic action), cost reduction, and long term treatments with reduced adverse effects.

Reactivation of varicella herpes virus (VHV), latent in individuals who have previously suffered varicella, gives rise to herpes zoster and in some cases leads to a sequela of post herpetic neuritis with severe pain which is refractory to analgesics. Many different antiviral agents have been tried without achieving satisfactory results. Of all the antiviral agents employed, acyclovir has been the most successful in reducing post herpetic pain. However acyclovir has not been as reliable as interferon alpha (IFN-alpha). We have previously looked into the use of transfer factor (TF) as a modulator of the immune system, specifically with respect to its effectiveness in the treatment of herpes zoster. In this work findings from a comparative clinical evaluation are presented. A double blind clinical trial of TF vs acyclovir was carried out in which 28 patients, presenting acute stage herpes zoster, were randomly assigned to either treatment group. Treatment was administered for seven days and the patients were subsequently submitted to daily clinical observation for an additional 14 days. An analogue visual scale was implemented in order to record pain and thereby served as the clinical parameter for scoring results. The group treated with TF was found to have a more favorable clinical course, P < or = 0.015. Laboratory tests to assess the immune profile of the patients were performed two days prior and 14 days after initial treatment. The results of these tests showed an increase in IFN-gamma levels, augmentation in the CD4+ cell population but not the percentage of T rosettes in the TF treated group. These parameters were however insignificantly modified in patients receiving acyclovir. Although TF treated patients showed an increase in CD4+ counts these cells remained below the levels for healthy individuals. The fact that IFN-gamma levels as well as the counts for CD4+ cells rose in the TF treated group and not in the acyclovir one is very significant and confirms the immunomodulating properties of TF.

Today's statement of transfer factor, an immunostimulator derived from leukocytes which enhances antiinfectious immunity, is observed in the review. Basic biological, physical and chemical characteristics of the transfer factor, its possible action mechanisms, and laboratory and clinical methods of use to cure infectious fungal (Candida, Coccidium), invasive (schistosomiasis, leishmaniasis, cryptosporidiosis), viral (varicella zoster, ophthalmic herpes, Herpes simplex types 1 and 2, H. zoster, H. simplex ceratitis, genital herpes, human herpes virus type 6, postherpetic neuritis, hepatitis B, AIDS), and bacterial infections (Mycobacterium leprae, M. tuberculosis, M. fortuitum, Salmonella cholerae suis, S. dublin, S. Virchov, Brucella abortus, Actinobacillus pleuropneumoniae, bacterial sepsis, Staphylococcus) are described.

The clinical feature of 20 cases with oral candidiasis in Sjögren's syndrome (SS) were reported, and the treatment effect by topical nystatin smearing, 2% sodium bicarbonate solution rinsing, and transfer factor injecting for about 2 months were analysed. The results showed that the diagnostic criterion of oral candidiasis in SS included two aspects: the SS changes confirmed by labial gland biopsy and candidal hyphae and spores found in a smear. The results indicated that the comprehensive treatments were proved to be effective for oral candidiasis in SS.

Unlabelled: The links of epileptic seizures with febrile diseases, as well as with common infections are generally known. Similarly, physicians are aware of the coincidence of epileptic activity with immunity disturbances, as well as of the effects of the antiepileptic drug phenytoin on the immunity system. Disturbances of immunity are commonly reported in 30% of the population. Our clinic is a consilliary regional centre for torpid epilepsies and sleep defects. The aim of study is to document the occurrence of immunity disturbances in unsuccessfully treated patients (5-25 years of age) with generalised convulsive epilepsy (GENKONV-GK) in a group containing 50 patients, and with partial epilepsy with complex symptomatology (PARTKOMP-PK) in a group containing 75 patients. At the same time, this studys objective resided in seeking evidence of the positive effect of immunomodulatory therapy. In all patients, the basic diagnosis had been stated in coincidence with the origin of epilepsy during hospitalisation in neurologic wards. In 1993-1995 our clinic supplemented the electrodiagnosis by a series of routine EEG which was focused at the recurrence of the disease. As a rule, each of the patients was subdued to a 24-hour EEG monitoring on the 12-canal apparatus. Individual supplementation by CT, MR and USG of the brain, the arrangement of anti-epileptic therapy and basic immunological examination were made during the first year of investigation. Still, after the stabilisation of anti-epileptic therapy (monitoring) and indicated immunomodulatory therapy was added., Results: The immunologic examination was negative in 4 patients, all being members of GENKONV group. Atopy was found in 56% of GK group, and in 65% of PK group. Disturbances of specific cellular immunity were revealed in 80% of the patients of the GK group, and in 85% of PK group. The signs of inflammatory activity and other signs of allergy were present to a lesser extent., Conclusions: Out of the amount of 125 patients only 3.2% yielded no disturbances of immunity. The application of immunomodulatory therapy appears to represent a promising supplementary-stabilisation therapy. (Tab. 2, Fig. 4, Ref. 5.)

Effect of immunotherapy with Transfer factor administered for a period of three months was studied in a group of ten epileptic patients, treated with carbamazepine or primidon previously and throughout the study. Out of eight patients, who finished the study we could notice significant reduction of epileptic discharges in eight patients. The results of this study prove that addition of immunomodulatory treatment to patients with intractable epilepsy could substantially improve the course of the disease in some patients. (Tab. 1, Fig. 5, Ref. 13.)

Background: approximately 40% of primary lung carcinoma patients who die within 1 month after a complete resection have residual tumor in regional or distant organs, emphasizing the importance of postoperative adjuvant therapy. In this study, the effectiveness of transfer factor (TF) and nocardia rubra-cell wall skeleton (N-CWS) as adjuvant therapy for patients with primary, completely resected nonsmall cell carcinoma of the lung was evaluated in a randomized controlled trial, Methods: A total of 82 patients with Stage I disease who had a complete resection were allocated randomly into 2 groups: TF + N-CWS (n = 41) or control (surgery only) (n = 41)., Results: The distributions of age, sex, histology, differentiation, T classification, tumor size, visceral pleural invasion, and the site of origin, were similar in the two groups. The 5- and 10-year disease specific survival rates in the TF + N-CWS group were 85% and 85%, respectively, and those in the control group were 72% and 64%, respectively. There was a statistically significant difference between the two groups (P = 0.041). When the survival was analyzed according to clinical characteristics, significant differences were observed in patients with no visceral pleural invasion or with T1 disease. The frequency of distant metastasis was significantly less in the TF + N-CWS group than in the control group., Conclusions: These results indicate that TF + N-CWS is beneficial as adjuvant therapy after surgical treatment of Stage I nonsmall cell carcinoma of the lung.

Clinicoimmunological characteristics were followed up in the course of laryngeal papillomatosis (LP) in 96 children. It was found that they had suppressed T-cell immunity, phagocytosis which still worsen with the disease aggravation and recurrences. A decrease in nonspecific resistance, properdin, lysozyme, complement and secretory IgA indicated impairment of nasopharyngeal and laryngeal local immunity. A scheme of combined treatment is proposed incorporating basic therapy with reaferon, systemic immunomodulators (thymalin, T-activin) and local immunocorrection. Such approach reduced the time of basic treatment and prolonged remission 2.5-3-fold.

Objective: To develop an alternative approach in conjunction with microwave-induced hyperthermia., Patients and Methods: Thermotherapy with microwave intracorporeal irradiation was used to treat 73 patients with bone tumors. The series was composed of 58 patients with malignant tumors and 15 with benign tumors: most of tumors occurred about knee joints (53/73 = 72.6%). The surgical procedure included separating the tumor bearing segment from surrounding normal tissues with a safe margin, cooling the normal tissues including the neurovascular bundle and the intraarticular structures with a water circulation system, while heating the tumor with the antenna array of a microwave system and providing an adequate soft-tissue cover for the dead bone. Postoperatively, an immune therapy regimen was carried out regularly. The patients' immunologic functions were monitored by assay of the subpopulation of T cells, IL-2 and sIL-2 R (soluble IL-2 receptor)., Results: Follow-up varied from 3 to 38 months (mean 19 months). Excluding 3 patients with malignancy in the vertebrae treated for palliation, 70 were evaluated according to oncological and orthopedic criteria. Five patients had local recurrence and required amputation. The remaining 65 had excellent local control. In 6 of the 55 patients with malignancy of the extremities, lung metastasis occurred one to two years after surgery. The oncological results were similar to those obtained by other limb-saving procedures. Pathological fracture occurred at devitalized bone in 5 patients. In 72.5% of the patients (29 of 40 tumor-free cases followed more than one year), knee joints functioned well, being stable and painless with almost full range of motion. Single photon emission computered tomography (SPECT) for 16 patients revealed revascularization of the devitalized tumor bearing bone segment could accomplish in one year or more. The immune states were improved in various extends after thermotherapy plus immunotherapy in the majority of patients., Conclusion: These results show that the use of microwave hyperthermia and adjuvant immunotherapy in conjunction with the surgical treatment of bone tumors can be considered a definitive procedure, which is safe and well-tolerated. The oncological and orthopedic results are encouraging.

40 infantile autistic patients were studied. They ranged from 6 years to 15 years of age at entry. 22 were cases of classical infantile autism; whereas 18 lacked one or more clinical defects associated with infantile autism ("pseudo-autism"). Of the 22 with classic autism, 21 responded to transfer factor (TF) treatment by gaining at least 2 points in symptoms severity score average (SSSA); and 10 became normal in that they were main-streamed in school and clinical characteristics were fully normalized. Of the 18 remaining, 4 responded to TF, some to other therapies. After cessation of TF therapy, 5 in the autistic group and 3 of the pseudo-autistic group regressed, but they did not drop as low as baseline levels.

The efficiency of HIV-1 specific transfer factor (TF) administration, combined with Zidovudine (ZDV), in asymptomatic persistent generalised lymphadenopaty, or AIDS related complex (ARC) patients was evaluated. Twenty patients were randomly assigned to receive only ZDV (1st group) or ZDV together with HIV-1-specific TF (2nd group). HIV-1-specific TF was administered orally at 2 x 10(7) cell equivalent daily for 15 days, and thereafter once a week for up to 6 months. There were no significant differences between the two groups in clinical evolution, red blood cells, haemoglobin, lymphocytes, CD20 subset, transaminases, beta-2-microglobulin, p24 antigen. White blood cells, CD8 lymphocytes as well as IL-2 levels increased in the second group, while the CD4 subset increased in the first group. The combination treatment with ZDV and TF appeared to be safe and well tolerated. Furthermore, levels of serum cytokines were investigated in 10 patients (8 asymptomatic and 2 ARC) treated with ZDV, and compared with 5 patients of the 2nd group (3 asymptomatic and 2 ARC) treated with ZDV plus HIV-1-specific TF. Peripheral lymphocytes, CD4, CD8 subsets, IL-2, TNF alpha, IL-6, p24 antigen, IL-2 soluble lymphocyte receptors (sR), CD4sR, CD8sR and beta-2-microglobulin were evaluated at the baseline and at the 3rd month. The CD4 subset was not significantly different in the two groups, whilst IL-2 increased in the 2nd group receiving ZDV plus TF, suggesting an activation of the Th1 secretion pattern.

Recurrent ocular herpes is an insoluble problem for the clinician. As cellular immunity plays an important role in controlling herpes relapses, and other studies have shown the efficacy of HSV-specific transfer factor (TF) for the treatment of herpes patients, an open clinical trial was undertaken in 134 patients (71 keratitis, 29 kerato-uveitis, 34 uveitis) suffering from recurrent ocular herpetic infections. The mean duration of the treatment was 358 days, and the entire follow-up period 189,121 before, and 64,062 days after TF treatment. The cell-mediated immune response to the viral antigens, evaluated by the lymphocyte stimulation test (LST) and the leucocyte migration test (LMT) (P < 0.001), was significantly increased by the TF treatment. The total number of relapses was decreased significantly during/after TF treatment, dropping from 832 before, to 89 after treatment, whereas the cumulative relapse index (RI) dropped, during the same period, from 13.2 to 4.17 (P < 0.0001). No side effects were observed. It is concluded that patients with relapsing ocular herpes can benefit from treatment with HSV-specific TF.

Results of conventional treatment of female non-bacterial recurrent cystitis (NBRC) are discouraging. Most patients show an unexpected high incidence of vaginal candidiasis, while their cell mediated immunity to Herpes simplex viruses (HSV) and Candida antigens seems impaired, and it is known that the persistence of mucocutaneous chronic candidiasis is mainly due to a selective defect of CMI to Candida antigens. Twenty nine women suffering of NBRC, and in whom previous treatment with antibiotics and non-steroid anti-inflammatory drugs was unsuccessful, underwent oral transfer factor (TF) therapy. TF specific to Candida and/or to HSV was administered bi-weekly for the first 2 weeks, and then once a week for the following 6 months. No side effects were observed during treatment. The total observation period of our cohort was 24379 days with 353 episodes of cystitis recorded and a cumulative relapse index (RI) of 43. The observation period during and after treatment was 13920 days with 108 relapses and a cumulative RI of 23 (P < 0.0001). It, thus, seems that specific TF may be capable of controlling NBRC and alleviate the symptoms.

Forty-four patients suffering from genital (22) and labial (22) herpes were orally treated with HSV-1/2-specific transfer factor (TF). TF was obtained by in vitro replication of a HSV-1/2-specific bovine dialysable lymphocyte extract. Treatment was administered bi-weekly the first 2 weeks, and then weekly for 6 months, most patients received 2-3 courses. The total observation period for all patients before treatment was 26,660 days, with 544 relapses, and a relapse index of 61.2, whereas the cumulative observation period during and after treatment was 16,945 days, with a total of 121 relapsing episodes and a cumulative RI of 21.4 (P < 0.0001). Results were equally significant when the 2 groups of patients (labial and genital) were considered separately. These observations confirm previous results obtained with bovine HSV-specific TF, and warrant further studies to establish HSV-specific TF as a choice of treatment for preventing herpes recurrences.

Transfer Factor (TF) was used in a placebo controlled pilot study of 20 patients with chronic fatigue syndrome (CFS). Efficacy of the treatment was evaluated by clinical monitoring and testing for antibodies to Epstein-Barr virus (EBV) and human herpes virus-6 (HHV-6). Of the 20 patients in the placebo-controlled trial, improvement was observed in 12 patients, generally within 3-6 weeks of beginning treatment. Herpes virus serology seldom correlated with clinical response. This study provided experience with oral TF, useful in designing a larger placebo-controlled clinical trial.

As conventional treatments are unsuccessful, the survival rate of stage D3 prostate cancer patients is poor. Reports have suggested the existence of humoral and cell-mediated immunity (CMI) against prostate cancer tumour-associated antigens (TAA). These observations prompted us to treat stage D3 prostate cancer patients with an in vitro produced transfer factor (TF) able to transfer, in vitro and in vivo, CMI against bladder and prostate TAA. Fifty patients entered this study and received one intramuscular injection of 2-5 units of specific TF monthly. Follow-up, ranging from 1 to 9 years, showed that complete remission was achieved in 2 patients, partial remission in 6, and no progression of metastatic disease in 14. The median survival was 126 weeks, higher than the survival rates reported in the literature for patients of the same stage.