NCT04525378

MSC-based Therapy in COVID-19-associated Acute Respiratory Distress Syndrome

Status unknown Phase 1 Last updated 26 August 2020

What this trial tests

Phase 1 trial testing Mesenchymal stromal cell-based therapy in Covid19 in 20 participants. Status unknown.

Timeline

1 July 2020

Primary endpoint
30 September 2020

31 October 2020

Quick facts

Lead sponsor	D'Or Institute for Research and Education
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 July 2020
Primary completion	30 September 2020
Estimated completion	31 October 2020
Sites	1 location across Brazil

Drugs / interventions tested

• Mesenchymal stromal cell-based therapy

Conditions studied

• Covid19 — all drugs for Covid19 →
• ARDS, Human — all drugs for ARDS, Human →

Sponsor

D'Or Institute for Research and Education

Who can join

18 and older, any sex, with Covid19 or ARDS, Human. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Considering the potential of mesenchymal stromal cells (MSCs) in the treatment of lung injuries by COVID-19, this pilot clinical trial evaluates the safety and potential efficacy of the cell therapy, administered intravenously, in patients with pneumonia associated with COVID-19-associated acute respiratory distress syndrome.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mesenchymal stem cell-based treatments for COVID-19: status and future perspectives for clinical applications.
   Chen L, Qu J, Kalyani FS, Zhang Q, et al · · 2022 · cited 31× · PMID 35187617 · DOI 10.1007/s00018-021-04096-y
2. The Clinical Trials of Mesenchymal Stromal Cells Therapy.
   Kouchakian MR, Baghban N, Moniri SF, Baghban M, et al · · 2021 · cited 30× · PMID 34745268 · DOI 10.1155/2021/1634782
3. Mesenchymal stromal/stem cells (MSCs) and MSC-derived extracellular vesicles in COVID-19-induced ARDS: Mechanisms of action, research progress, challenges, and opportunities.
   Moradinasab S, Pourbagheri-Sigaroodi A, Zafari P, Ghaffari SH, et al · · 2021 · cited 27× · PMID 33932694 · DOI 10.1016/j.intimp.2021.107694
4. Lung regeneration: diverse cell types and the therapeutic potential.
   Chen Y, Li Z, Ji G, Wang S, et al · · 2024 · cited 24× · PMID 38405059 · DOI 10.1002/mco2.494
5. Clinical applications of mesenchymal stromal cell-based therapies for pulmonary diseases: An Update and Concise Review.
   Chen X, Wang F, Huang Z, Wu Y, et al · · 2021 · cited 23× · PMID 34220313 · DOI 10.7150/ijms.59218
6. An update to "novel therapeutic approaches for treatment of COVID-19".
   Hossein-Khannazer N, Shokoohian B, Shpichka A, Aghdaei HA, et al · · 2021 · cited 21× · PMID 33392632 · DOI 10.1007/s00109-020-02027-1
7. Is there a place for mesenchymal stromal cell-based therapies in the therapeutic armamentarium against COVID-19?
   da Silva KN, Gobatto ALN, Costa-Ferro ZSM, Cavalcante BRR, et al · · 2021 · cited 19× · PMID 34315546 · DOI 10.1186/s13287-021-02502-7
8. Cell therapy strategies for COVID-19: Current approaches and potential applications.
   Zaki MM, Lesha E, Said K, Kiaee K, et al · · 2021 · cited 18× · PMID 34380619 · DOI 10.1126/sciadv.abg5995