At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 23 enrolled
Drug / intervention
Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) +1 moredrug
Likely dose
Lactated Ringer's Solution 1.5mLfrom 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 IIa Randomized Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Non-ischemic Heart Failure
In Brief
A Phase 2 clinical trial evaluating Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) and Lactated Ringer's Solution for Non-Ischemic Heart Failure. Completed, enrolled 23 participants across 5 sites.
Detailed Summary
A phase IIa study to assess the safety and preliminary efficacy of intravenous dose of ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells in subjects with non-ischemic heart failure.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Ischemic Heart Failure
CountriesUnited States
CollaboratorsStemedica Cell Technologies, Inc.
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJun 2014
First PostedJun 2015
Primary CompletionMay 2017
TodayJul 2026
First PostedJun 10, 2015
Enrollment StartJun 1, 2014
Primary CompletionMay 11, 2017
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.1 years ago
Interventions
Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)drug
One time infusion Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg.
Lactated Ringer's Solutiondrug
One time infusion 1.5mL/kg