At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 28 enrolled

Drug / intervention

Mesenchymal Stromal Cells +1 morebiological

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04345601

NCT04345601Phase 2Completed

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Single Donor Banked Bone Marrow Mesenchymal Stromal Cells for the Treatment of COVID-19 Induced ARDS: A Non-Blinded Randomized, Controlled Study

Baylor College of Medicine·interventional·Posted Apr 14, 2020·Updated Oct 9, 2024

In Brief

A Phase 2 clinical trial evaluating Mesenchymal Stromal Cells and Supportive Care for Sars-CoV2 and 2 related conditions. Completed, enrolled 28 participants across 1 site.

Detailed Summary

\*\*\*At this time, we are only enrolling at Houston Methodist Hospital (HMH)/Baylor College of Medicine (BCM) and are not shipping cells outside of BCM/HMH.\*\*\* This is a study for patients who have respiratory infection caused by SARS-CoV-2 that have not gotten better. Because there is no standard treatment for this infection, patients are being asked to volunteer for a gene transfer research study using mesenchymal stem cells (MSCs). Stem cells are cells that do not yet have a specific function in the body. Mesenchymal stem cells (MSCs) are a type of stem cell that can be grown from bone marrow (the spongy tissue inside of bones). Stem cells can develop into other types of more mature (specific) cells, such as blood and muscle cells. The purpose of this study is to see if MSCs versus controls can help to treat respiratory infections caused by SARS-CoV-2.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSars-CoV2, Acute Respiratory Distress Syndrome, COVID-19

CountriesUnited States

CollaboratorsCenter for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute

Timeline

Phase 2CompletedFinished

202120222023202420252026

First PostedApr 2020

Enrollment StartFeb 2021

Primary CompletionJan 2023

TodayJul 2026

First PostedApr 14, 2020

Enrollment StartFeb 12, 2021

Primary CompletionJan 10, 2023

TodayJul 2, 2026

Enrollment to primary: 1.9 yearsPosted 6.2 years ago

Interventions

Mesenchymal Stromal Cellsbiological

Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.

Supportive Careother

Patients will receive supportive care per their treating physician