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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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.