Mesenchymal Stem Cells for the Treatment of COVID-19

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

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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