NCT04452097

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

A Phase 1/2a Study of the Safety and Efficacy of BX-U001 for the Treatment of Severe COVID-19 Pneumonia With Moderate to Severe Acute Respiratory Distress Syndrome (ARDS).

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Baylx Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19
• ARDS
• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Human umbilical cord mesenchymal stem cells + best supportive care	hUC-MSC product will be administered intravenously in addition to the standard of care treatment.
OTHER	Placebo control + best supportive care	Placebo control will be administered intravenously in addition to the standard of care treatment.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-07-01
• Completion: 2027-09-28
• First posted: 2020-06-30
• Last updated: 2025-12-29

Regulatory

• FDA-regulated drug study