NCT04625738: MSC-COVID19

Efficacy of Infusions of MSC From Wharton Jelly in the SARS-Cov-2 (COVID-19) Related Acute Respiratory Distress Syndrome

Completed Phase 2 Last updated 5 November 2021

What this trial tests

Phase 2 trial testing Ex vivo expanded Wharton's Jelly Mesenchymal Stem Cells in COVID19 ARDS in 30 participants. Completed in 1 September 2021.

Timeline

6 November 2020

Primary endpoint
14 May 2021

1 September 2021

Quick facts

Lead sponsor	Central Hospital, Nancy, France
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	30
Start date	6 November 2020
Primary completion	14 May 2021
Estimated completion	1 September 2021
Sites	1 location across France

Drugs / interventions tested

• Ex vivo expanded Wharton's Jelly Mesenchymal Stem Cells — full drug profile →
• Placebo

Conditions studied

• COVID19 ARDS — all drugs for COVID19 ARDS →

Sponsor

Central Hospital, Nancy, France

Who can join

18 and older, any sex, with COVID19 ARDS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Mesenchymal stem cells (MSCs) are of potential help in acute respiratory distress syndrome (ARDS), due to their anti-inflammatory properties.

The investigators will analyze the effect of 3 iterative infusions of ex vivo expanded Wharton's Jelly MSCs (total dose 2.10\^6/kg) in patients with ARDS due to COVID19, who require mechanical ventilation.

Publications & conference data

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

1. Immunomodulatory Mechanisms of Mesenchymal Stem Cells and Their Potential Clinical Applications.
   Huang Y, Wu Q, Tam PKH. · · 2022 · cited 143× · PMID 36077421 · DOI 10.3390/ijms231710023
2. Mesenchymal stem cells and their derived exosomes to combat Covid-19.
   Yousefi Dehbidi M, Goodarzi N, Azhdari MH, Doroudian M. · · 2022 · cited 41× · PMID 34363275 · DOI 10.1002/rmv.2281
3. Regulation of Inflammatory Cytokine Storms by Mesenchymal Stem Cells.
   Wang L, Li Y, Xu M, Deng Z, et al · · 2021 · cited 38× · PMID 34394132 · DOI 10.3389/fimmu.2021.726909
4. Mesenchymal stem cell-based therapy and exosomes in COVID-19: current trends and prospects.
   Abdelgawad M, Bakry NS, Farghali AA, Abdel-Latif A, et al · · 2021 · cited 33× · PMID 34419143 · DOI 10.1186/s13287-021-02542-z
5. 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
6. 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
7. 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
8. 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