Mesenchymal Stem Cells for the Treatment of COVID-19

Phase 1

Completed

• Conditions: Prophylaxis; Covid19
• Interventions: Biological: PrimePro; Other: Placebo

• Registration Number: NCT04573270
• Lead Sponsor: Thomas Advanced Medical LLC

Brief 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.

Study Timeline

• Study Start: 2020-04-24
• Primary Completion: 2020-08-20
• Status Verified: 2020-09
• Study Completion: 2020-09-01
• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-30
• Last Update Submitted: 2020-09-30
• Study First Posted: 2020-10-05
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthcare Providers Experimental	PrimePro	7 healthy subjects (healthcare providers following patients admitted to hospital suffering complications from COVID-19) will be randomized and equally distributed between placebo and experimental intervention.
COVID-19 Patients Experimental	PrimePro	13 COVID-19 infected subjects (Patients admitted to hospital suffering complications from COVID-19) will be randomized and equally distributed between placebo and experimental intervention.
Healthcare Providers Placebo	Placebo	7 healthy subjects (healthcare providers following patients admitted to hospital suffering complications from COVID-19) will be randomized and equally distributed between placebo and experimental intervention.
COVID-19 Patients Placebo	Placebo	13 COVID-19 infected subjects (Patients admitted to hospital suffering complications from COVID-19) will be randomized and equally distributed between placebo and experimental intervention.

Primary Outcome Measures

Name	Time	Method
Survival Rates	30 Days	Survival Rate in COVID-19 infected patients admitted to hospital for complications
Contraction Rates	30 Days	Contraction Rate of COVID-19 in healthy healthcare workers following patients admitted to hospital for complications due to COVID-19

Trial Locations

Locations (1)

Southern California Hospital at Culver City / Southern California Hospital at Hollywood; 🇺🇸 Culver City, California, United States