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NCT04573270 Clinical Trial

Mesenchymal Stem Cells for the Treatment of COVID-19

Covid19 Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04573270
Other study ID # Pro00043080
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 24, 2020
Est. completion date September 1, 2020

Study information
Verified date September 2020
Source Thomas Advanced Medical LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date September 1, 2020
Est. primary completion date August 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18 and older

- Ability to provide informed consent

Exclusion Criteria:

- Active or recent malignancy (within last 2 years)

- Inability to provide informed consent

- Current enrollment in any other COVID-19 treatment study

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• PrimePro
Intravenous Injection
Other:
• Placebo
Intravenous Injection

Locations
Country Name City State
United States Southern California Hospital at Culver City / Southern California Hospital at Hollywood Culver City California

Sponsors (2)
Lead Sponsor Collaborator
Thomas Advanced Medical LLC HeartStem Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival Rates Survival Rate in COVID-19 infected patients admitted to hospital for complications 30 Days
Primary Contraction Rates Contraction Rate of COVID-19 in healthy healthcare workers following patients admitted to hospital for complications due to COVID-19 30 Days
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