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NCT Number: NCT04573270

Mesenchymal Stem Cells for the Treatment of COVID-19

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral Prophylaxis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Southern California Hospital at Culver City / Southern California Hospital at Hollywood

Culver City, California, 92032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PrimePro

Biological

Intravenous Injection

Placebo

Other

Intravenous Injection

Primary outcomes

  1. Survival Rates

    Time frame: 30 Days

    Survival Rate in COVID-19 infected patients admitted to hospital for complications

  2. Contraction Rates

    Time frame: 30 Days

    Contraction Rate of COVID-19 in healthy healthcare workers following patients admitted to hospital for complications due to COVID-19

Sponsors and collaborators

Lead sponsor

Thomas Advanced Medical LLC

Industry

Collaborators

  • HeartStem Institute

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 5, 2020
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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