Mesenchymal Stem Cells for the Treatment of COVID-19

T

Thomas Advanced Medical

Status and phase

Completed
Phase 1

Conditions

Covid19
Prophylaxis

Treatments

Biological: PrimePro
Other: Placebo

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT04573270
Pro00043080

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Triple Blind

40 participants in 4 patient groups, including a placebo group

COVID-19 Patients Experimental
Experimental group
Description:
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.
Treatment:
Biological: PrimePro
COVID-19 Patients Placebo
Placebo Comparator group
Description:
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.
Treatment:
Other: Placebo
Healthcare Providers Experimental
Experimental group
Description:
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.
Treatment:
Biological: PrimePro
Healthcare Providers Placebo
Placebo Comparator group
Description:
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.
Treatment:
Other: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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