NCT04573270

Mesenchymal Stem Cells for the Treatment of COVID-19

A Pilot Phase Study Evaluating the Effects of a Single Mesenchymal Stem Cell Injection in Patients With Suspected or Confirmed COVID-19 Infection and Healthcare Providers Exposed to Coronavirus Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Thomas Advanced Medical LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This double blind, placebo controlled, multi-arm, multi-site study investigates the safety and efficacy of stem cell therapy for the treatment of patients admitted to hospital suffering complications from COVID-19 and the treatment of healthy subjects (healthcare providers) for prophylactic effect following those patients.

Detailed description

Recent preliminary data from Wuhan/China have claimed that intravenous injections of mesenchymal stem cells derived from human umbilical chords have resulted in complete recovery of COVID-19 infected elderly patients with respiratory failure. This study investigates the efficacy and safety of a single umbilical cord derived stem cell intravenous injection in patients with suspected or confirmed COVID-19 infection with fever and respiratory illness. A second arm will test efficacy and safety of a single umbilical cord derived stem cell intravenous injection to healthcare providers at high exposure rates to COVID-19 infection.

Conditions

• Covid19
• Prophylaxis

Interventions

Type	Name	Description
BIOLOGICAL	PrimePro	Intravenous Injection
OTHER	Placebo	Intravenous Injection

Timeline

• Start date: 2020-04-24
• Primary completion: 2020-08-20
• Completion: 2020-09-01
• First posted: 2020-10-05
• Last updated: 2020-10-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study