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Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

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

A Phase 2A Randomized, Placebo-Controlled Study of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise

NCT04992247•Sorrento Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This is a Phase 2a randomized, placebo-controlled study designed to investigate the efficacy, safety and tolerability of COVI-MSC in treating post COVID-19 "long haul" pulmonary compromise.

Detailed Description

This is a Phase 2a randomized, placebo-controlled multicenter study designed to investigate the efficacy, safety and tolerability of COVI-MSC in treating post COVID-19 "long haul" pulmonary compromise. COVI-MSC will be administered intravenously on Day 0, Day 2, and Day 4.

Eligibility

Age

18 - No limit years

Sex

ALL

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
•Any significant medical condition, laboratory value or other illness that in the investigator's opinion would interfere or prevent safe participation in the study
•History of a splenectomy, lung transplant or lung lobectomy
•Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)

Key Dates

Start Date

February 1, 2024

Primary Completion Date

July 1, 2024

Completion Date

September 1, 2024

Last Updated

April 17, 2024

Conditions

Covid19

Interventions

COVI-MSC

BIOLOGICAL

Placebo

BIOLOGICAL

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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