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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-31

Study Completion Date

2022-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome

NCT04909879

Acute Respiratory Distress Syndrome Ards

WITHDRAWN PHASE2

Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells for COVID-19-Induced Acute Respiratory Distress

NCT04728698

Covid19 ARDS

WITHDRAWN PHASE2

Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treatment of COVID-19 Acute Respiratory Distress

NCT04905836

Covid19

UNKNOWN PHASE2

Study of Intravenous COVI-MSC for Treatment of COVID-19-Induced Acute Respiratory Distress

NCT04903327

Covid19

TERMINATED PHASE2

Clinical Study for Subjects With COVID-19 Using Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells

NCT05017298

Corona Virus Infection Covid19

NOT_YET_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

COVI-MSC 1 vial

Subjects will receive intravenous infusions of COVI-MSC (one vial, \~18.5 million cells) on Day 0, Day 2, and Day 4.

Group Type EXPERIMENTAL

COVI-MSC

Intervention Type BIOLOGICAL

COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells

COVI-MSC 2 vials

Subjects will receive intravenous infusions of COVI-MSC (two vials, \~37 million cells) on Day 0, Day 2, and Day 4.

Group Type EXPERIMENTAL

COVI-MSC

Intervention Type BIOLOGICAL

COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

COVI-MSC

COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No