At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 16 enrolled
Drug / intervention
20 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.
A Phase I/II, Randomized, Double Blind, Pilot Trial to Evaluate the Safety and Efficacy of Allogeneic Mesenchymal Human Stem Cells Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects
In Brief
A Phase 2 clinical trial evaluating 20 million Allogeneic Mesenchymal Human Stem Cells and 100 million Allogeneic Mesenchymal Human Stem Cells for Diabetes Mellitus, Type 2. Completed, enrolled 16 participants across 1 site.
Detailed Summary
This is a 16 subject trial to demonstrate the safety of allogeneic hMSCs administered via infusion therapy for diabetic subjects with endothelial dysfunction.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 2016
Enrollment StartOct 2017
Primary CompletionAug 2019
Study CompletionSep 2020
TodayJul 2026
First PostedSep 1, 2016
Enrollment StartOct 20, 2017
Primary CompletionAug 26, 2019
Study CompletionSep 3, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.8 years ago
Interventions
20 million Allogeneic Mesenchymal Human Stem Cellsdrug
1 single intravenous infusion
100 million Allogeneic Mesenchymal Human Stem Cellsdrug
1 single intravenous infusion