Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2020-04-24
2020-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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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.
PrimePro
Intravenous Injection
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.
Placebo
Intravenous Injection
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.
PrimePro
Intravenous Injection
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.
Placebo
Intravenous Injection
Interventions
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PrimePro
Intravenous Injection
Placebo
Intravenous Injection
Eligibility Criteria
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Inclusion Criteria
* Ability to provide informed consent
Exclusion Criteria
* Inability to provide informed consent
* Current enrollment in any other COVID-19 treatment study
18 Years
ALL
Yes
Sponsors
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HeartStem Institute
UNKNOWN
Thomas Advanced Medical LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Ernst R Von Schwarz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
HeartStem Institute, Southern California Hospital at Culver City
Locations
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Southern California Hospital at Culver City / Southern California Hospital at Hollywood
Culver City, California, United States
Countries
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Other Identifiers
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Pro00043080
Identifier Type: -
Identifier Source: org_study_id
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