NCT04490486

Umbilical Cord Tissue (UC) Derived Mesenchymal Stem Cells (MSCs) Versus Placebo to Treat Acute Pulmonary Inflammation Due to COVID-19

Phase I, Randomized, Double Blinded, Placebo Control Study to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Umbilical Cord Tissue (UC) Derived Mesenchymal Stem Cells (MSCs) Versus Placebo to Treat Acute Pulmonary Inflammation Due to COVID-19 With Moderate to Severe Symptoms

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Joshua M Hare · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the safety of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UCMSCs) administered intravenously in patients with acute pulmonary inflammation due to COVID-19 with moderately severe symptoms

Conditions

• COVID-19
• Acute Respiratory Distress Syndrome
• Corona Virus Infection

Interventions

Type	Name	Description
BIOLOGICAL	UCMSCs	100 x 106 (100 million) UCMSCs delivered via peripheral intravenous infusion.
OTHER	Placebo	Placebo, a solution of 1% human serum albumin in Plasmalyte A, delivered via peripheral intravenous infusion

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2020-07-29
• Last updated: 2022-05-12

Regulatory

• FDA-regulated drug study