Object: Many experimental studies on spinal cord injuries (SCIs) support behavioral improvement after Schwann cell treatment. This study was conducted to evaluate safety issues 2 years after intramedullary Schwann cell transplantation in 33 consecutively selected patients with SCI. Methods: Of 356 patients with SCIs who had completed at least 6 months of a conventional rehabilitation program and who were screened for the study criteria, 33 were enrolled. After giving their informed consent, they volunteered for participation. They underwent sural nerve harvesting and intramedullary injection of a processed Schwann cell solution. Outcome assessments included a general health questionnaire, neurological examination, and functional recordings in terms of American Spinal Injury Association (ASIA) and Functional Independence Measure scoring, which were documented by independent observers. There were 24 patients with thoracic and 9 with cervical injuries. Sixteen patients were categorized in ASIA Grade A, and the 17 remaining participants had ASIA Grade B. Results: There were no cases of deep infection, and the follow-up MR imaging studies obtained at 2 years did not reveal any deformity related to the procedure. There was no case of permanent neurological worsening or any infectious or viral complications. No new increment in syrinx size or abnormal tissue and/or tumor formation were observed on contrast-enhanced MR imaging studies performed 2 years after the treatment. Conclusions: Preliminary results, especially in terms of safety, seem to be promising, paving the way for future cell therapy trials.

Background: High morbidity and mortality rates of the COVID-19 pandemic have made it a global health priority. Acute respiratory distress syndrome (ARDS) is one of the most important causes of death in COVID-19 patients. Mesenchymal stem cells have been the subject of many clinical trials for the treatment of ARDS because of their immunomodulatory, anti-inflammatory, and regenerative potentials. The aim of this phase I clinical trial was the safety assessment of allogeneic placenta-derived mesenchymal stem cells (PL-MSCs) intravenous injection in patients with ARDS induced by COVID-19. Methods: We enrolled 20 patients suffering from ARDS caused by COVID-19 who had been admitted to the intensive care unit. PL-MSCs were isolated and propagated using a xeno-free/GMP compliant protocol. Each patient in the treatment group (N = 10) received standard treatment and a single dose of 1 × 10⁶ cells/kg PL-MSCs intravenously. The control groups (N = 10) only received the standard treatment. Clinical signs and laboratory tests were evaluated in all participants at the baseline and during 28 days follow-ups. Results: No adverse events were observed in the PL-MSC group. Mean length of hospitalization, serum oxygen saturation, and other clinical and laboratory parameters were not significantly different in the two groups (p > 0.05). Conclusion: Our results demonstrated that intravenous administration of PL-MSCs in patients with COVID-19 related ARDS is safe and feasible. Further studies whit higher cell doses and repeated injections are needed to evaluate the efficacy of this treatment modality. Trial registration: Iranian Registry of Clinical Trials (IRCT); IRCT20200621047859N4. Registered 1 March 2021, https://en.irct.ir/trial/52947.