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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04573270
Enrollment
40
Registered
2020-10-05
Start date
2020-04-24
Completion date
2020-09-01
Last updated
2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Prophylaxis

Keywords

stem cell therapy, umbilical cord stem cells, amniotic stem cells, stem cells, MSC, Mesenchymal Stem Cell, Medicinal Signaling Cell

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.

Interventions

BIOLOGICALPrimePro

Intravenous Injection

OTHERPlacebo

Intravenous Injection

Sponsors

HeartStem Institute
CollaboratorUNKNOWN
Thomas Advanced Medical LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Survival Rates30 DaysSurvival Rate in COVID-19 infected patients admitted to hospital for complications
Contraction Rates30 DaysContraction Rate of COVID-19 in healthy healthcare workers following patients admitted to hospital for complications due to COVID-19

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026