Trials / Terminated
TerminatedNCT04397796
Study of the Safety of Therapeutic Tx With Immunomodulatory MSC in Adults With COVID-19 Infection Requiring Mechanical Ventilation
Phase 1b Randomized, Double-Blind, Placebo-Controlled Study Of The Safety Of Therapeutic Treatment With Immunomodulatory Mesenchymal Stem Cells In Adults With COVID-19 Infection Requiring Mechanical Ventilation
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- ImmunityBio, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 1b randomized, double-blind, placebo-controlled study in adult subjects with Coronavirus Disease 2019 (COVID-19). This clinical trial will evaluate the preliminary safety and efficacy of BM-Allo.MSC vs placebo in treating subjects with severe disease requiring ventilator support during COVID 19 infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BM-Allo.MSC | BM-Allo.MSC for Infusion, is manufactured from normal donor derived bone marrow product and are phenotypically CD73+, CD90+, CD105+, and negative for CD14-, CD34-, CD45-, HLA-DR-. |
| BIOLOGICAL | Placebo | plasmalyte and human albumin |
Timeline
- Start date
- 2020-08-03
- Primary completion
- 2020-09-06
- Completion
- 2020-09-06
- First posted
- 2020-05-21
- Last updated
- 2024-09-05
- Results posted
- 2024-09-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04397796. Inclusion in this directory is not an endorsement.