Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS

Summary

This is a phase 1/2a study including 2 parts, phase 1 and phase 2a. The phase 1 part is an open-label, single-arm, dose-escalating study to evaluate the safety and explore the dose limiting toxicity and maximum tolerated dose of a human umbilical cord derived mesenchymal stem cell product (BX-U001) in severe COVID-19 pneumonia patients with acute respiratory distress syndrome (ARDS). Qualified subjects after the screening will be divided into low, medium, or high dose groups to receive a single intravenous infusion of BX-U001 at the dose of 0.5×10\^6, 1.0×10\^6, or 1.5×10\^6 cells/kg of body weight, respectively. The Phase 2a part is a randomized, placebo-controlled, double-blind clinical trial examining the safety and biological effects of BX-U001 at the appropriate dose selected from phase 1 for severe COVID-19 pneumonia patients with the same inclusion/exclusion criteria as the phase 1 part.

Timeline

Start

2026-06-01

Primary completion

2027-07-01

Completion

2027-09-28

Outcome

Outcome not reported

Stopped (Business): “It is a strategic decision by the company, coupled with low incidence of ARDS cases following widespread vaccination efforts.”

Drugs

Indications