Mesenchymal Stem Cells for the Treatment of COVID-19

Purpose

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.

Conditions

  • Covid19
  • Prophylaxis

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
This study is a randomized assignment, double-blind, placebo-controlled, multi-arm, multi-site study located at Southern California Hospitals at Culver City and Hollywood.
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04573270
Status
Completed
Sponsor
Thomas Advanced Medical LLC

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.