دورية أكاديمية
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
العنوان: | 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 |
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المؤلفون: | 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 |
المصدر: | Stem Cell Research & Therapy, Vol 13, Iss 1, Pp 1-12 (2022) |
بيانات النشر: | BMC, 2022. |
سنة النشر: | 2022 |
المجموعة: | LCC:Medicine (General) LCC:Biochemistry |
مصطلحات موضوعية: | Acute respiratory distress syndrome (ARDS), Cell therapy, Coronavirus, COVID-19, Placenta mesenchymal stem cells (PL-MSC), Medicine (General), R5-920, Biochemistry, QD415-436 |
الوصف: | 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 . |
نوع الوثيقة: | article |
وصف الملف: | electronic resource |
اللغة: | English |
تدمد: | 1757-6512 |
Relation: | https://doaj.org/toc/1757-6512 |
DOI: | 10.1186/s13287-022-02953-6 |
URL الوصول: | https://doaj.org/article/a838c54e0cee4745884944e8f8098202 |
رقم الأكسشن: | edsdoj.838c54e0cee4745884944e8f8098202 |
قاعدة البيانات: | Directory of Open Access Journals |
تدمد: | 17576512 |
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DOI: | 10.1186/s13287-022-02953-6 |