Back to resultsMesenchymal Stem Cells for the Treatment of COVID-19
Primary Purpose
Covid19, Prophylaxis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PrimePro
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring stem cell therapy, umbilical cord stem cells, amniotic stem cells, stem cells, MSC, Mesenchymal Stem Cell, Medicinal Signaling Cell
Eligibility 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
Sites / Locations
- Southern California Hospital at Culver City / Southern California Hospital at Hollywood
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
COVID-19 Patients Experimental
COVID-19 Patients Placebo
Healthcare Providers Experimental
Healthcare Providers Placebo
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Survival Rates
Survival Rate in COVID-19 infected patients admitted to hospital for complications
Contraction Rates
Contraction Rate of COVID-19 in healthy healthcare workers following patients admitted to hospital for complications due to COVID-19
Secondary Outcome Measures
Full Information
NCT ID
NCT04573270
First Posted
September 23, 2020
Last Updated
September 30, 2020
Sponsor
Thomas Advanced Medical LLC
Collaborators
HeartStem Institute
1. Study Identification
Unique Protocol Identification Number
NCT04573270
Brief Title
Mesenchymal Stem Cells for the Treatment of COVID-19
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 24, 2020 (Actual)
Primary Completion Date
August 20, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Advanced Medical LLC
Collaborators
HeartStem Institute
4. Oversight
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
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Prophylaxis
Keywords
stem cell therapy, umbilical cord stem cells, amniotic stem cells, stem cells, MSC, Mesenchymal Stem Cell, Medicinal Signaling Cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COVID-19 Patients Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
COVID-19 Patients Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Healthcare Providers Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthcare Providers Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
PrimePro
Intervention Description
Intravenous Injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Intravenous Injection
Primary Outcome Measure Information:
Title
Survival Rates
Description
Survival Rate in COVID-19 infected patients admitted to hospital for complications
Time Frame
30 Days
Title
Contraction Rates
Description
Contraction Rate of COVID-19 in healthy healthcare workers following patients admitted to hospital for complications due to COVID-19
Time Frame
30 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernst R Von Schwarz, MD, PhD
Organizational Affiliation
HeartStem Institute, Southern California Hospital at Culver City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern California Hospital at Culver City / Southern California Hospital at Hollywood
City
Culver City
State/Province
California
ZIP/Postal Code
92032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Mesenchymal Stem Cells for the Treatment of COVID-19
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