tetano
Editor, Senior Moderator
Stem Cell Res Ther
. 2022 Jul 28;13(1):365.
doi: 10.1186/s13287-022-02953-6.
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[SUP] #[/SUP][SUP] 1 [/SUP], Fatemeh Salimian[SUP] #[/SUP][SUP] 2 [/SUP], Atefeh Abedini[SUP] 3 [/SUP], Samrand Fattah Ghazi[SUP] 4 [/SUP], Masud Yunesian[SUP] 5 [/SUP], Sepideh Alavi-Moghadam[SUP] 1 [/SUP], Jalil Makarem[SUP] 4 [/SUP], Keivan Majidzadeh-A[SUP] 6 [/SUP], Ali Hatamkhani[SUP] 2 [/SUP], Maryam Moghri[SUP] 2 [/SUP], Abbas Danesh[SUP] 3 [/SUP], Mohammad Reza Haddad-Marandi[SUP] 2 [/SUP], Hassan Sanati[SUP] 2 [/SUP], Fereshteh Abbasvandi[SUP] 2 [/SUP], Babak Arjmand[SUP] 1 [/SUP], Pourya Azimi[SUP] 7 [/SUP], Ardeshir Ghavamzadeh[SUP] 8 [/SUP], Ramin Sarrami-Forooshani[SUP] 9 [/SUP]
Affiliations
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 × 10[SUP]6[/SUP] 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 .
Keywords: Acute respiratory distress syndrome (ARDS); COVID-19; Cell therapy; Coronavirus; Placenta mesenchymal stem cells (PL-MSC).
. 2022 Jul 28;13(1):365.
doi: 10.1186/s13287-022-02953-6.
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[SUP] #[/SUP][SUP] 1 [/SUP], Fatemeh Salimian[SUP] #[/SUP][SUP] 2 [/SUP], Atefeh Abedini[SUP] 3 [/SUP], Samrand Fattah Ghazi[SUP] 4 [/SUP], Masud Yunesian[SUP] 5 [/SUP], Sepideh Alavi-Moghadam[SUP] 1 [/SUP], Jalil Makarem[SUP] 4 [/SUP], Keivan Majidzadeh-A[SUP] 6 [/SUP], Ali Hatamkhani[SUP] 2 [/SUP], Maryam Moghri[SUP] 2 [/SUP], Abbas Danesh[SUP] 3 [/SUP], Mohammad Reza Haddad-Marandi[SUP] 2 [/SUP], Hassan Sanati[SUP] 2 [/SUP], Fereshteh Abbasvandi[SUP] 2 [/SUP], Babak Arjmand[SUP] 1 [/SUP], Pourya Azimi[SUP] 7 [/SUP], Ardeshir Ghavamzadeh[SUP] 8 [/SUP], Ramin Sarrami-Forooshani[SUP] 9 [/SUP]
Affiliations
- PMID: 35902979
- DOI: 10.1186/s13287-022-02953-6
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 × 10[SUP]6[/SUP] 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 .
Keywords: Acute respiratory distress syndrome (ARDS); COVID-19; Cell therapy; Coronavirus; Placenta mesenchymal stem cells (PL-MSC).