Mesenchymal Stem Cells for the Treatment of COVID-19
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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 covid19
Started Apr 2020
Shorter than P25 for phase_1 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedFirst Submitted
Initial submission to the registry
September 23, 2020
CompletedFirst Posted
Study publicly available on registry
October 5, 2020
CompletedOctober 5, 2020
September 1, 2020
4 months
September 23, 2020
September 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (4)
COVID-19 Patients Experimental
EXPERIMENTAL13 COVID-19 infected subjects (Patients admitted to hospital suffering complications from COVID-19) will be randomized and equally distributed between placebo and experimental intervention.
COVID-19 Patients Placebo
PLACEBO COMPARATOR13 COVID-19 infected subjects (Patients admitted to hospital suffering complications from COVID-19) will be randomized and equally distributed between placebo and experimental intervention.
Healthcare Providers Experimental
EXPERIMENTAL7 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.
Healthcare Providers Placebo
PLACEBO COMPARATOR7 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.
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 and older
- Ability to provide informed consent
You may not qualify if:
- Active or recent malignancy (within last 2 years)
- Inability to provide informed consent
- Current enrollment in any other COVID-19 treatment study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thomas Advanced Medical LLClead
- HeartStem Institutecollaborator
Study Sites (1)
Southern California Hospital at Culver City / Southern California Hospital at Hollywood
Culver City, California, 92032, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ernst R Von Schwarz, MD, PhD
HeartStem Institute, Southern California Hospital at Culver City
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2020
First Posted
October 5, 2020
Study Start
April 24, 2020
Primary Completion
August 20, 2020
Study Completion
September 1, 2020
Last Updated
October 5, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share
Data will be blinded and password protected. Research publications will be produced for medical journals. Participating Investigators will have password protected access only.