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Objective: Kienböck disease is a rare condition characterized by severe pain and restricted wrist movement. Variouspalliative methods have been proposed as therapeutic strategies for alleviating symptoms. Mesenchymal stromal cell transplantationhas been suggested as an innovative and promising approach due to its potential for inducing regeneration andimmunomodulation in the necrotic tissue. This study aims to evaluate the safety of autologous bone marrow derivedmesenchymal stromal cells (BM-MSCs) transplantation after core decompression in Kienböck disease.Materials and Methods: In this phase I of an open-label clinical trial, three patients (one female and two males) withstage 2 Kienböck disease underwent autologous BM-MSCs transplantation following lunate core decompression. Thepatients were followed up for six months to assess safety as well as secondary clinical outcomes, including pain level,range of motion (ROM), and functional disability.Results: Safety of BM-MSCs injection following the core decompression was evaluated by recording post-treatmentcomplications during the six-month follow-up. No adverse events (AEs) or severe AEs (SAEs) were reported, indicatingthat BM-MSCs injection after core decompression is a safe intervention. All patients showed a remarkable reductionin visual analog scale (VAS) scores and "Disabilities of the Arm, Shoulder, and Hand" (DASH) questionnaire scores,suggesting the therapeutic potential of this intervention. Moreover, an increase in the ROM indicated that BM-MSCstransplantation can improve wrist functionality. Additionally, radiographic assessments before and after cell infusiondemonstrated a reduction in lunate sclerosis after six months of follow-up.Conclusion: The transplantation of autologous BM-MSCs following lunate core decompression seems to be a safeclinical intervention and may lead to pain relief in patients with Kienböck disease. Furthermore, this procedure may helpprevent disease progression during the follow-up period (registration number: NCT02646007).

Objective Nonunion is defined as a minimum of a 9-month period of time since an injury with no visibly progressive signs of healing for 3 months. Recent studies show that application of mesenchymal stromal cells (MSCs) in the laboratory setting is effective for bone regeneration. Animal studies have shown that MSCs can be used to treat nonunions. For the first time in an Iranian population, the present study investigated the safety of MSC implantation to treat human lower limb long bone nonunion. Materials and Methods It is a prospective clinical trial for evaluating the safety of using autologus bone marrow derived mesenchymal stromal cells for treating nonunion. Orthopedic surgeons evaluated 12 patients with lower limb long bone nonunion for participation in this study. From these, 5 complied with the eligibility criteria and received MSCs. Under fluoroscopic guidance, patients received a one-time implantation of 20-50×106 MSCs into the nonunion site. All patients were followed by anterior-posterior and lateral X-rays from the affected limb, in addition to hematological, biochemical, and serological laboratory tests obtained before and 1, 3, 6, and 12 months after the implantation. Possible adverse effects that included local or systemic, serious or non-serious, and related or unrelated effects were recorded during this time period. Results From a safety perspective, all patients tolerated the MSCs implantation during the 12 months of the trial. Three patients had evidence of bony union based on the after implantation Xrays. Conclusion The results have suggested that implantation of bone marrow-derived MSCs is a safe treatment for nonunion. A double-blind, controlled clinical trial is required to assess the efficacy of this treatment (Registration Number: NCT01206179).

Objective: Nonunion is defined as a minimum of 9 months since injury without any visible progressive signs of healing for 3 months. Recent literature has shown that the application of mesenchymal stromal cells is safe, in vitro and in vivo, for treating long bone nonunion. The present study was performed to investigate the safety of mesenchymal stromal cell (MSC) implantation in combination with platelet lysate (PL) product for treating human long bone nonunion. Materials and Methods: In this case series clinical trial, orthopedic surgeons visited eighteen patients with long bone nonunion, of whom 7 complied with the eligibility criteria. These patients received mesenchymal stromal cells (20 million cells implanted once into the nonunion site using a fluoroscopic guide) in combination with PL product. For evaluation of the effects of this intervention all the patients were followed up by taking anterior-posterior and lateral X-rays of the affected limb before and 1, 3, 6, and 12 months after the implantation. All side effects (local or systemic, serious or non-serious, related or unrelated) were observed during this time period. Results: From a safety perspective the MSC implantation in combination with PL was very well tolerated during the 12 months of the trial. Four patients were healed; based on the control X- ray evidence, bony union had occurred. Conclusion: Results from the present study suggest that the implantation of bone marrow- derived MSCs in combination with PL is safe for the treatment of nonunion. A double blind, controlled clinical trial is required to assess the efficacy of this treatment (Registration Number: NCT01206179).