NCT05689008

UC-MSCs in the Treatment of Severe and Critical COVID-19 Patients With Refractory Hypoxia

Status unknown Phase 3 Last updated 18 January 2023

What this trial tests

Phase 3 trial testing UC-MSCs treatment in Mesenchymal Stem Cell in 60 participants. Status unknown.

Timeline

10 January 2023

Primary endpoint
31 March 2023

30 July 2023

Quick facts

Lead sponsor	Shanghai East Hospital
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	10 January 2023
Primary completion	31 March 2023
Estimated completion	30 July 2023
Sites	1 location across China

Drugs / interventions tested

• UC-MSCs treatment — full drug profile →

Conditions studied

• Mesenchymal Stem Cell — all drugs for Mesenchymal Stem Cell →
• COVID-19 Pneumonia — all drugs for COVID-19 Pneumonia →

Sponsor

Shanghai East Hospital

Who can join

Adults 18 to 85, any sex, with Mesenchymal Stem Cell or COVID-19 Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this randomized, controlled, open-labeled interventional clinical trial is to test the efficacy and safety of umbilical cord mesenchymal stem cells (UC- MSCs) in the treatment of severe and critical COVID-19 patients with refractory hypoxia even after sufficient standard treatment according to the tenth edition of Chinese guidelines for COVID-19 infection. The main questions it aims to answer are: 1. The efficacy of UC-MSCs in the treatment of severe and critical COVID-19 patients with refractory hypoxia. 2. The safety of UC-MSCs in the treatment of severe and critical COVID-19 patients. 3. The potential immune mechanisms of UC- MSCs in the treatment of severe and critical COVID-19 patients. Participants will receive standard therapy, or the UC-MSCs treatment. For the standard treatment, it will be conducted according the 10th edition of Chinese guidelines for severe or critical COVID-19 infection. For UC-MSCs treatment, participants will be given UC-MSCs instillation at the first and fourth day after assignment. Blood examples will be taken at indicated time for arterial blood gas analysis and other tests. And participants should also objectively report their symptoms change and other information related to the treatment as listed the research protocol.

Publications & conference data

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

1. Emerging Landscape of Mesenchymal Stem Cell Senescence Mechanisms and Implications on Therapeutic Strategies.
   Wang J, Zhang M, Wang H. · · 2024 · cited 13× · PMID 39144566 · DOI 10.1021/acsptsci.4c00284
2. Therapeutic utility of human umbilical cord-derived mesenchymal stem cells-based approaches in pulmonary diseases: Recent advancements and prospects.
   Meng M, Zhang WW, Chen SF, Wang DR, et al · · 2024 · cited 10× · PMID 38455096 · DOI 10.4252/wjsc.v16.i2.70
3. Mechanisms of Potential Therapeutic Utilization of Mesenchymal Stem Cells in COVID-19 Treatment.
   Fang Y, Lao P, Tang L, Chen J, et al · · 2023 · cited 8× · PMID 37395459 · DOI 10.1177/09636897231184611
4. Stem cell therapies in the clinic.
   Acharya S, Shaha S, Bibbey MG, Mukherji M, et al · · 2025 · cited 3× · PMID 40385529 · DOI 10.1002/btm2.70000
5. Immune-Cell-Based Therapy for COVID-19: Current Status.
   Wang Y, Liang Q, Chen F, Zheng J, et al · · 2023 · cited 3× · PMID 38005826 · DOI 10.3390/v15112148
6. Modular mastery of inflammation: umbilical cord mesenchymal stem cells as a therapeutic frontier.
   Yin L, Sun CY, Chen GL, Xiang Z, et al · · 2025 · PMID 41488628 · DOI 10.3389/fimmu.2025.1721947