A Study to Assess the Effect of Intravenous Dose of (aMBMC) to Subjects With Non-ischemic Heart Failure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02467387|
Recruitment Status : Unknown
Verified April 2016 by CardioCell LLC.
Recruitment status was: Active, not recruiting
First Posted : June 10, 2015
Last Update Posted : April 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Non-Ischemic Heart Failure||Drug: Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) Drug: Lactated Ringer's Solution||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||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|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||April 2017|
Experimental: Experimental: Human (aMBMC)
Intervention: One time intravenous infusion of 1.5 million (aMBMC) per kg administered at approximately 2mL/min. Maximum dose as for 100kg subject or 150 million cells for any subject 100kg or more.
Drug: Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)
One time infusion Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg.
Other Name: Mesenchymal Stem Cells, (MSC) Marrow Stromal Cells.
Placebo Comparator: Placebo:Lactated Ringer's Solution (LRS)
Intervention: One time intravenous infusion of 1.5mL/kg Lactated Ringer's Solution (LRS) administered at a constant rate of approximately 2mL/min.
Drug: Lactated Ringer's Solution
One time infusion 1.5mL/kg
Other Name: (LRS)
- Safety will be evaluated by the incidence, severity, and relationship of AEs and SAEs [ Time Frame: Change from Baseline, days 30, 60, 90, days 270 and 450 post initial infusion ]
- Change in LVEF from baseline to day 90 post-initial infusion. After crossover phase all subjects will be evaluated for changes from the new baseline (Day 90 after initial infusion) to Day 90 post second infusion. [ Time Frame: Baseline to Day 90 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467387
|United States, District of Columbia|
|MedStar Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|United States, Georgia|
|Emory University Hospital|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|Northwestern University Centers for Heart Failure Therapy|
|Chicago, Illinois, United States, 60611|
|United States, New York|
|Stony Brook Heart Institute|
|Stony Brook, New York, United States, 11794|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania, Heart Failure and Transplant Program|
|Philedelphia, Pennsylvania, United States, 19104|
|Study Director:||Kristrun Stardal, RN, BSN||Clinical Operations Manager|