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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Prophylaxis
• Intervention / Treatment: Biological: PrimePro; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Culver City, California, United States, 92032
      • Southern California Hospital at Culver City / Southern California Hospital at Hollywood

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COVID-19 Patients Experimental; 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.	Biological: PrimePro; Intravenous Injection
Placebo Comparator: COVID-19 Patients 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.	Other: Placebo; Intravenous Injection
Experimental: Healthcare Providers Experimental; 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.	Biological: PrimePro; Intravenous Injection
Placebo Comparator: Healthcare Providers 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.	Other: Placebo; Intravenous Injection

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Thomas Advanced Medical LLC
• Collaborators: HeartStem Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2020
• Primary Completion (Actual): August 20, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: stem cells; MSC; Mesenchymal Stem Cell; umbilical cord stem cells; stem cell therapy; amniotic stem cells; Medicinal Signaling Cell
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Pro00043080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will be blinded and password protected. Research publications will be produced for medical journals. Participating Investigators will have password protected access only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes