Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise

Sorrento Therapeutics

Status and phase

Withdrawn

Phase 2

Conditions

Covid19

Treatments

Biological: COVI-MSC

Study type

Interventional

Funder types

Industry

Identifiers

NCT04909892

MSC-PLH-201

Details and patient eligibility

About

This is a Phase 1b study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 "long haulers" with pulmonary compromise.

Full description

This is a Phase 1b multicenter study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 "long haulers" with pulmonary compromise.

COVI-MSC will be administered intravenously on Day 0, Day 2, and Day 4.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Has had prior laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
Has had a recent (within a week) negative SARS-CoV-2 test (an approved PCR or antigen test)
Has had at least moderate or severe post-COVID-19 pulmonary symptoms for at least 3 months which have resulted in reduced physical functioning compared to pre-COVID-19 status
Willing to follow contraception guidelines

Exclusion criteria

Clinically improving pulmonary status over the month prior to screening
Undergone a previous stem cell infusion unrelated to this trial
Pregnant or breast feeding or planning for either during the study
Suspected uncontrolled active bacterial, fungal, viral, or other infection
History of a splenectomy, lung transplant or lung lobectomy
Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)