Mesenchymal Stem Cells for the Treatment of COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Covid19, Prophylaxis

Intervention / Treatment
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* Biological: PrimePro
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVID-19 Patients Experimental<br>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<br>* Intravenous Injection<br>|
| Placebo Comparator: COVID-19 Patients Placebo<br>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<br>* Intravenous Injection<br>|
| Experimental: Healthcare Providers Experimental<br>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<br>* Intravenous Injection<br>|
| Placebo Comparator: Healthcare Providers Placebo<br>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<br>* Intravenous Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Rates | Survival Rate in COVID-19 infected patients admitted to hospital for complications | 30 Days | 
| Contraction Rates | Contraction Rate of COVID-19 in healthy healthcare workers following patients admitted to hospital for complications due to COVID-19 | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stem cell therapy, umbilical cord stem cells, amniotic stem cells, stem cells, MSC, Mesenchymal Stem Cell, Medicinal Signaling Cell