At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
Allogeneic hMSCsbiological
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.
A Phase II, Randomized, Blinded, Study of the Safety and Efficacy of Transendocardial Injection of Allogeneic Human Mesenchymal Stem Cells (hMSCs) (20 Million or 100 Million Total MSCs) in Patients With Chronic Ischemic Left Ventricular Dysfunction Secondary to Myocardial Infarction.
In Brief
A Phase 2 clinical trial evaluating Allogeneic hMSCs for Chronic Ischemic Left Ventricular Dysfunction and Myocardial Infarction. Completed, enrolled 30 participants across 1 site.
Detailed Summary
Thirty (30) patients with chronic ischemic left ventricular dysfunction secondary to MI scheduled to undergo cardiac catheterization will be enrolled in the study. This is a phase II study intended to gain additional safety and efficacy assessments among two dose levels previously studied in a phase I setting.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsThe Emmes Company, LLC
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 2013
Enrollment StartFeb 2014
Primary CompletionMar 2017
Study CompletionSep 2017
TodayJul 2026
First PostedDec 17, 2013
Enrollment StartFeb 13, 2014
Primary CompletionMar 2, 2017
Study CompletionSep 18, 2017
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 12.5 years ago
Interventions
Allogeneic hMSCsbiological
Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection