CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 26 enrolled / 26 target
Drug / intervention
100 million Allogeneic Mesenchymal Human Stem Cells +1 moredrug
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/NCT04776239
NCT04776239Phase 1CompletedUpdate Overdue (0.4/mo)Completion was 15mo ago
CompareCT.gov

Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease.

Joshua M Hare·interventional·Posted Mar 1, 2021·Updated Jun 16, 2026

In Brief

A Phase 1 clinical trial evaluating 100 million Allogeneic Mesenchymal Human Stem Cells and Placebo for Diabetes Mellitus and Ischemic Heart Disease. Completed, enrolled 26 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

The purpose of this study is to test the hypothesis that allogeneic Mesenchymal Stem Cells (MSCs) promote systemic and coronary endothelial repair through rescue of bone marrow progenitors in type 2 diabetic patients with symptomatic IHD compared to placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Ischemic Heart Disease
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedMar 1, 2021
Enrollment StartAug 16, 2021
Primary CompletionMar 30, 2025
Study CompletionAug 26, 2025
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 5.3 years ago

Arms & Interventions

Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Groupexperimental

Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).

Drug: 100 million Allogeneic Mesenchymal Human Stem Cells
Group B: Placebo Groupplacebo_comparator

Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.

Other: Placebo

Interventions

100 million Allogeneic Mesenchymal Human Stem Cellsdrug

1 single intravenous infusion

Placeboother

Placebo delivered via peripheral intravenous infusion