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1. Adipose tissue-derived stromal vascular fraction for treating hands of patients with systemic sclerosis: a multicentre randomized trial Autologous AD-SVF versus placebo in systemic sclerosis

Author

Elisabeth Jouve, Chloé Dumoulin, David Bocara, Audrey Cras, Olivier Boyer, Françoise Dignat-George, Julie Brunet, Ygal Benhamou, Isabelle Auquit-Auckbur, Cécile Philandrianos, Nicolas Schleinitz, Veronique Bourgarel, Dominique Casanova, Camille Giverne, Stéphanie Mallet, Rosanna Ferreira, Yves-Marie Pers, Aurélie Daumas, Brigitte Granel, Joseph Château, Florence Sabatier, Hervé Levesque, Maxime Abellan Lopez, Jérôme Larghero, Jean-Robert Harlé, Laurent Arnaud, Jeremy Magalon, Guy Magalon, J. Veran, Arnaud Hot, L. Giraudo, Alexandra Giuliani, Dominique Farge, Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre d'Investigation Clinique [Hôpital de la Conception - APHM] (CIC), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Hôpital Nord [CHU - APHM], Assistance Publique - Hôpitaux de Marseille (APHM), CHU Rouen, Normandie Université (NU), Physiopathologie, Autoimmunité, maladies Neuromusculaires et THErapies Régénératrices (PANTHER), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Recherche clinique appliquée à l'hématologie (URP_3518), Université Paris Cité (UPCité), McGill University = Université McGill [Montréal, Canada], Service de Médecine Interne [CHU Rouen], Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Endothélium, valvulopathies et insuffisance cardiaque (EnVI), Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Immunologie humaine, physiopathologie & immunothérapie (HIPI (UMR_S_976 / U976)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Hôpital privé Jean Mermoz [Lyon], Hôpital Edouard Herriot [CHU - HCL], and Hospices Civils de Lyon (HCL)

Subjects
medicine.medical_specialty, Population, Adipose tissue, Placebo, Scleroderma, law.invention, Rheumatology, Randomized controlled trial, law, Fibrosis, Internal medicine, CHFS, medicine, Humans, Pharmacology (medical), education, education.field_of_study, Scleroderma, Systemic, Stromal Vascular Fraction, business.industry, Stromal vascular fraction, medicine.disease, Hand, Autologous adipose tissue-derived stromal vascular fraction, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Adipose Tissue, Regenerative medicine, Systemic sclerosis, business, Cochin Hand Function Scale
Abstract

Objective To assess the superiority of adipose tissue-derived stromal vascular fraction (AD-SVF) injection into the fingers vs placebo in reducing hand disability in systemic sclerosis (SSc) patients. Methods We performed a double-blind, multicentre, phase II trial from October 2015 to January 2018 in France. SSc patients with a Cochin Hand Function Scale (CHFS) ≥20/90 were randomized 1:1 to receive injection of AD-SVF or placebo. AD-SVF was obtained using the automated processing Celution 800/CRS system. The placebo was lactated Ringer’s solution. The primary efficacy end point was the change of the CHFS score from baseline to 3 months. Secondary efficacy endpoints included the CHFS score at 6 months, hand function, vasculopathy, hand pain, skin fibrosis, sensitivity of the finger pulps, Scleroderma Health Assessment Questionnaire, patients and physician satisfaction, and safety. Results Forty patients were randomized. The AD-SVF and placebo groups were comparable for age, sex ratio, disease duration, skin fibrosis of the hands and main cause of hand disability. After 3 months’ follow-up, hand function significantly improved in both groups with no between-group difference of CHFS (mean change of −9.2 [12.2] in the AD-SVF group vs −7.6 [13.2] in the placebo group). At 6 months, hand function improved in both groups. Conclusion This study showed an improvement of hand function in both groups over time, with no superiority of the AD-SVF. Considering the limits of this trial, studies on a larger population of patients with homogeneous phenotype and hand handicap should be encouraged to accurately assess the benefit of AD-SVF therapy. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov, NCT02558543. Registered on September 24, 2015.

Published
2021

2. Inter-center comparison of good-manufacturing-practices compliant stromal vascular fraction and proposal for release acceptance criteria: a review of 364 productions

Author

Pauline François, Giulio Rusconi, Laurent Arnaud, Luca Mariotta, Laurent Giraudo, Greta Minonzio, Julie Veran, Baptiste Bertrand, Chloé Dumoulin, Fanny Grimaud, Luc Lyonnet, Dominique Casanova, Camille Giverne, Audrey Cras, Guy Magalon, Françoise Dignat-George, Florence Sabatier, Jeremy Magalon, and Gianni Soldati

Abstract

Background : Even though the manufacturing processes of the stromal vascular fraction for clinical use are performed in compliance with the good-manufacturing practices applying to advanced therapy medicinal products, specifications related to stromal vascular fraction quality remain poorly defined. We analyzed stromal vascular fraction clinical batches from two independent good-manufacturing practices-compliant manufacturing facilities, the Swiss Stem Cell Foundation (SSCF) and Marseille University Hospitals (AP-HM), with the goal of defining appropriate and harmonized release acceptance criteria.Methods: This retrospective analysis reviewed the biological characteristics of 364 batches of clinical-grade stromal vascular fraction. Collected data included cell viability, recovery yield, cell subset distribution of stromal vascular fraction and microbiological quality. Results: stromal vascular fraction from SSCF cohort demonstrated a higher viability (89.33 % ± 4.30 %) and recovery yield (2.54 × 105 ± 1.22 × 105 viable nucleated cells (VNCs) per mL of adipose tissue) than stromal vascular fraction from AP-HM (84.20% ± 5.96% and 2.25 × 105 ± 1.11 × 105 VNCs). AP-HM batches were significantly less contaminated (95.71 % of sterile batches versus 74.15 %) The cell subset distribution was significantly different (higher proportion of endothelial cells and lower proportion of leukocytes and pericytes in SSCF cohort). Conclusions: Both centers agreed that a good-manufacturing practices-compliant stromal vascular fraction batch should exert a viability equal or superior to 80 %; a minimum recovery yield of 1.50 × 105 VNCs per mL of adipose tissue; a proportion of adipose-derived stromal cells at least equal to 20 %; and a proportion of leukocytes under 50 %. In addition, a multiparameter gating strategy for stromal vascular fraction analyze is proposed.

Published
2021

3. Autologous Myoblasts for the Treatment of Fecal Incontinence

Author

Olivier Boyer, Stéphanie Le Corre, Anne-Marie Leroi, Aurélie Bisson, Edith Koning, Jérémie Martinet, Francis Michot, Camille Giverne, Estelle Houivet, Jean-Jacques Tuech, Justine Déhayes, Valérie Bridoux, Jacques Benichou, Pascal Chambon, Serge Jacquot, and Dominique Bastit

Subjects
Adult, medicine.medical_specialty, Urology, Placebo-controlled study, Placebo, Injections, law.invention, Myoblasts, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Randomized controlled trial, stem cells, law, medicine, Clinical endpoint, Humans, Fecal incontinence, Prospective Studies, Prospective cohort study, business.industry, Middle Aged, Randomized Controlled Trials, 3. Good health, Surgery, Clinical trial, fecal incontinence, Treatment Outcome, medicine.anatomical_structure, 030220 oncology & carcinogenesis, Sphincter, Female, 030211 gastroenterology & hepatology, cell therapy, medicine.symptom, business, autologous myoblasts
Abstract

Objective: The aim of this study was to evaluate the efficacy of intrasphincteric injections of autologous myoblasts (AMs) in fecal incontinence (FI) in a controlled study. Summary of Background Data: Adult stem cell therapy is expected to definitively cure FI by regenerating damaged sphincter. Preclinical data and results of open-label trials suggest that myoblast therapy may represent a noninvasive treatment option. Methods: We conducted a phase 2 randomized, double-blind, placebo-controlled study of intrasphincteric injections of AM in 24 patients. The study compared outcome after AM (n = 12) or placebo (n = 12) injection using Cleveland Clinic Incontinence (CCI), score at 6 and 12 months. Patients in the placebo group were eligible to receive frozen AM after 1 year. Results: At 6 months, the median CCI score significantly decreased from baseline in both the AM (9 vs 15, P = 0.02) and placebo (10 vs 15, P = 0.01) groups. Hence, no significant difference was found between the 2 groups (primary endpoint) at 6 months. At 12 months, the median CCI score continued to ameliorate in the AM group (6.5 vs 15, P = 0.006), while effect was lost in the placebo group (14 vs 15, P = 0.35). Consequently, there was a higher response rate at 12 months in the treated than the placebo arm (58% vs 8%, P = 0.03). After delayed frozen AM injection in the placebo group, the response rate was 60% (6/10) at 12 months. Conclusions: Intrasphincteric AM injections in FI patients have shown tolerance, safety, and clinical benefit at 12 months despite a transient placebo effect at 6 months.

Published
2018

4. Chromosomal instability but lack of transformation in human myoblast preparations

Author

Marek Lamacz, Francis Michot, Aurélie Bisson, Laurent Drouot, Camille Giverne, Serge Jacquot, Francis Roussel, Pascal Chambon, Sahil Adriouch, Laetitia Demoulins, Géraldine Joly-Helas, Jean-Michel Flaman, Laetitia Jean, Olivier Boyer, Stéphanie Le Corre, Thierry Frebourg, and Christelle Doucet

Subjects
Male, Carcinogenesis, Biomedical Engineering, Gene Dosage, lcsh:Medicine, Mice, SCID, Biology, Genomic Stability, Immunophenotyping, Cell therapy, Myoblasts, Mice, Inbred NOD, Chromosome instability, Chromosomal Instability, Myocyte, Animals, Humans, Induced pluripotent stem cell, Cells, Cultured, Cellular Senescence, Cell Proliferation, Transplantation, Comparative Genomic Hybridization, lcsh:R, Cell Biology, Middle Aged, Embryonic stem cell, Cell biology, Transformation (genetics), Cell Transformation, Neoplastic, Phenotype, Cell culture, Karyotyping, Female
Abstract

Genetic alterations have recently been described as emerging during the culture of embryonic stem cells or induced pluripotent stem cells, raising concerns about their safety in future clinical use. Myoblasts are adult stem cells with important therapeutic potential that have been used in clinical trials for almost 20 years, but their genome integrity has not yet been established. Here we produced 10 human myoblast preparations and investigated their genomic stability. At the third passage, half of the preparations had a normal karyotype and half showed one to four alterations/30 metaphases. Chromosome 2 trisomy was found in 1–2/30 meta-phases and/or 2/100 nuclei by FISH in 3/10 samples, and there was no other recurrent anomaly. When prolonging cultures, these erratic abnormalities were never associated with a growth advantage. Cellular senescence was manifested in all samples by growth arrest before passage 15. Expression of TERT was always negative. Molecular analysis of individual p53 transcripts did not reveal tumorigenic mutations. CGH array (10 samples) and exome sequencing (one sample) failed to detect copy number variations or accumulation of mutations, respectively. Myoblasts did not grow either in soft agar or in vivo after injection in immunodeficient mice. Hence, occasional genomic abnormalities may occur during myoblast culture but are not associated with risk of transformation.

Published
2015

5. Massive expansion of regulatory T-cells following interleukin 2 treatment during a phase I-II dendritic cell-based immunotherapy of metastatic renal cancer

Author

Olivier Boyer, Bernard Gattegnio, Benoit Barrou, Nathalie Chaput, David Klatzmann, Serge Herson, Helene Trebeden-Negre, Frederic Selles, Nicolas Thioun, Mustapha Cherai, Annick Delcourt, François M. Lemoine, Roger Lacave, Agnes Buzyn, Camille Giverne, Dalia Dimitri, Mathilde Sibony, Michelle Rosenzwajg, Alain Six, Nabih Azar, Jean Pierre Lotz, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Role des Cellules Dendritiques Dans la Regulation des Effecteurs de l'Immunite Antitumorale, Université Paris-Sud - Paris 11 (UP11)-Institut National de la Santé et de la Recherche Médicale (INSERM), Réseau National des Systèmes Complexes (RNSC), Centre de Coopération Internationale en Recherche Agronomique pour le Développement (Cirad)-Institut National de la Recherche Agronomique (INRA)-Institut National de Recherche en Informatique et en Automatique (Inria)-Institut Français de Recherche pour l'Exploitation de la Mer (IFREMER)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CGE-CPU-Centre National de la Recherche Scientifique (CNRS), Institut Cochin (UMR_S567 / UMR 8104), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), CHU Tenon [AP-HP], Service de biothérapies [CHU Pitié-Salpétrière], Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Pitié-Salpêtrière [APHP], Université Paris-Sud - Paris 11 ( UP11 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Réseau National des Systèmes Complexes ( RNSC ), Centre de Coopération Internationale en Recherche Agronomique pour le Développement ( CIRAD ) -Institut National de la Recherche Agronomique ( INRA ) -Institut National de Recherche en Informatique et en Automatique ( Inria ) -Institut Français de Recherche pour l'Exploitation de la Mer ( IFREMER ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -CGE-CPU-Centre National de la Recherche Scientifique ( CNRS ), Institut Cochin ( UMR_S567 / UMR 8104 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ), Service de pathologie, Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Tenon [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Pitié-Salpêtrière [APHP], Centre National de la Recherche Scientifique (CNRS)-CPU-CGE-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Français de Recherche pour l'Exploitation de la Mer (IFREMER)-Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de la Recherche Agronomique (INRA)-Centre de Coopération Internationale en Recherche Agronomique pour le Développement (Cirad), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Descartes - Paris 5 (UPD5), CHU Tenon [APHP], Departement Hospitalo- Universitaire - Inflammation, Immunopathologie, Biothérapie [Paris] (DHU - I2B), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Centre National de la Recherche Scientifique (CNRS)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Trousseau [APHP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP]

Subjects
Interleukin 2, Adult, Male, Cancer Research, medicine.medical_treatment, [ SDV.IMM.IMM ] Life Sciences [q-bio]/Immunology/Immunotherapy, Antigens, CD34, Antineoplastic Agents, Cancer Vaccines, T-Lymphocytes, Regulatory, Immunophenotyping, 03 medical and health sciences, 0302 clinical medicine, Immune system, Cancer immunotherapy, Antigens, Neoplasm, Medicine, Humans, Antigen-presenting cell, Carcinoma, Renal Cell, 030304 developmental biology, Aged, 0303 health sciences, business.industry, Dendritic cell, Immunotherapy, [SDV.IMM.IMM]Life Sciences [q-bio]/Immunology/Immunotherapy, Dendritic Cells, Middle Aged, Kidney Neoplasms, 3. Good health, medicine.anatomical_structure, Oncology, Tumor progression, 030220 oncology & carcinogenesis, Immunology, Interleukin-2, Female, Bone marrow, business, medicine.drug
Abstract

International audience; Cytotoxic chemotherapy is ineffective in metastatic renal cancer. However, systemic administration of interleukin 2 (IL-2) or infusion of dendritic cells (DCs) loaded with tumor extracts can lead to some response rates with concomitant survival improvements. We report the results of a phase I-II pilot study combining DCs and IL-2 where six patients were included. DCs were derived from bone marrow CD34+ cells and loaded with autologous tumor extracts. CD34-DC vaccines were infused subcutaneously at day 45, 52, 59, 90 and 120 following surgery in combination with IL-2, that was subsequently administrated after the 3rd and 4th DC vaccinations. Preparation of tumor extracts and CD34-DCs were satisfactory in all patients but one. Due to rapid tumor progression, one patient was excluded before vaccination. In the 4 remaining patients, two received 3 vaccinations, while the 2 others received 5 vaccinations and the full IL-2 treatment. No adverse effect due to the vaccinations was observed. A specific immune response against autologous tumor cells was observed in the 2 patients who completed the treatment. Interestingly, these 2 patients had a more prolonged survival than the patients receiving 3 vaccinations. Importantly, a transient and massive increase of circulating natural regulatory T-cells (nTregs) was evidenced in 3 patients following IL-2 administration. Overall, the use of CD34-DC vaccines is feasible, safe and non-toxic. A specific anti-tumor immune response can be detected. However, our data highlights that IL-2 is a potent inducer of nTregs in vivo and as such may have a negative impact on cancer immunotherapy.

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