Trials / Terminated
TerminatedNCT04362189
Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19
A Randomized, Placebo-Controlled, Double-Blind, Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Hope Biosciences Research Foundation · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Hope Biosciences is conducting a research study of an investigational product called allogeneic adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) as treatment for patients suspected to have COVID-19. The study purpose is to evaluate the safety and efficacy of four IV infusions of either placebo or HB-adMSCs in subjects with COVID-19.
Detailed description
This is a Phase II, Randomized, Placebo-Controlled, Double-Blinded, Clinical Trial to Assess Efficacy of HB-adMSCs to treat COVID-19 patients. 100 patients will be enrolled. Eligible participants are suspected to have COVID-19 and consent to participate. The primary endpoints of this study are to detect change from baseline in inflammatory markers (IL-6, IL-10, TNF-alpha, C Reactive protein), improving oxygenation, and decreasing time to return to room air (RTRA). In addition, participants will be monitored for overall clinical status by standard clinical laboratories, change from baseline in exploratory markers (D-dimer, myoglobin, troponin, creatinine kinase MB, serum ferritin, CD4:CD8 ratio, CD3-CD56+), time to negative PCR results and clinical improvement according to 7-point ordinal scale, as well as incidence of adverse events.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HB-adMSC | Hope Biosciences allogeneic adipose-derived mesenchymal stem cells |
| OTHER | Placebo | Saline |
Timeline
- Start date
- 2020-06-30
- Primary completion
- 2021-09-30
- Completion
- 2021-09-30
- First posted
- 2020-04-24
- Last updated
- 2025-09-26
- Results posted
- 2023-07-25
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04362189. Inclusion in this directory is not an endorsement.