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Mesenchymal Stem Cells for the Treatment of COVID-19

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ClinicalTrials.gov Identifier: NCT04573270
Recruitment Status : Completed
First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
HeartStem Institute
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Covid19 Prophylaxis Biological: PrimePro Other: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 24, 2020
Actual Primary Completion Date : August 20, 2020
Actual Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04573270


Locations
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United States, California
Southern California Hospital at Culver City / Southern California Hospital at Hollywood
Culver City, California, United States, 92032
Sponsors and Collaborators
Thomas Advanced Medical LLC
HeartStem Institute
Investigators
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Principal Investigator: Ernst R Von Schwarz, MD, PhD HeartStem Institute, Southern California Hospital at Culver City
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Responsible Party: Thomas Advanced Medical LLC
ClinicalTrials.gov Identifier: NCT04573270    
Other Study ID Numbers: Pro00043080
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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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
Keywords provided by Thomas Advanced Medical LLC:
stem cell therapy
umbilical cord stem cells
amniotic stem cells
stem cells
MSC
Mesenchymal Stem Cell
Medicinal Signaling Cell
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases