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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Thomas Advanced Medical LLC
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Survival Rates
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Placebo (Other)
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.
Intervention: PrimePro (Biological)
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.
Intervention: Placebo (Other)
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.
Intervention: PrimePro (Biological)
Outcomes
Primary Outcomes
Survival Rates
Time Frame: 30 Days
Survival Rate in COVID-19 infected patients admitted to hospital for complications
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
Secondary Outcomes
No secondary outcomes reported