Trials / Unknown
UnknownNCT05682586
UC-MSCs in the Treatment of Severe and Critical COVID-19 Patients
Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Severe and Critical COVID-19 Patients
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Shanghai East Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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. The main questions it aims to answer are: 1. The efficacy of UC-MSCs in the treatment of severe and critical COVID-19 patients. 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, Paxlovid treatment or the UC-MSCs treatment. For the standard treatment, it will be conducted according the 9th edition of Chinese guidelines for 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | umbilical cord mesenchymal stem cells | Participants will receive two doses of UC-MSCs treatment, each dose will contain 1\*10\^6 cells/kg suspended in 100 ml albumin solution. |
| DRUG | paxlovid | Participants will receive standard dose of paxlovid therapy, which contains 300mg namatevir and 100mg litonavir twice a day for a total course of 5 days. |
Timeline
- Start date
- 2023-01-09
- Primary completion
- 2023-03-31
- Completion
- 2023-07-01
- First posted
- 2023-01-12
- Last updated
- 2023-01-12
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05682586. Inclusion in this directory is not an endorsement.