Stem Cell Research & Therapy (Jul 2022)

Human placenta-derived mesenchymal stem cells transplantation in patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 (phase I clinical trial): safety profile assessment

  • Hamid Reza Aghayan,
  • Fatemeh Salimian,
  • Atefeh Abedini,
  • Samrand Fattah Ghazi,
  • Masud Yunesian,
  • Sepideh Alavi-Moghadam,
  • Jalil Makarem,
  • Keivan Majidzadeh-A,
  • Ali Hatamkhani,
  • Maryam Moghri,
  • Abbas Danesh,
  • Mohammad Reza Haddad-Marandi,
  • Hassan Sanati,
  • Fereshteh Abbasvandi,
  • Babak Arjmand,
  • Pourya Azimi,
  • Ardeshir Ghavamzadeh,
  • Ramin Sarrami-Forooshani

DOI
https://doi.org/10.1186/s13287-022-02953-6
Journal volume & issue
Vol. 13, no. 1
pp. 1 – 12

Abstract

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Abstract 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 .

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