Phase II Combination Stem Cell Therapy for the Treatment of Severe Coronary Ischemia(CI)
The present investigation will be a Phase II, single center, placebo-controlled, randomized, dose escalation, infusion modality (intracoronary vs transendocardial injection using the Cordis Biosense NOGASTAR TM Mapping Catheter with the Biosense MYOSTAR TM left ventricular injection catheter) transplantation of an autologous (your own stem cells) combination of bone marrow-derived stem cells into myocardium for the treatment of severe coronary ischemia.
The purpose of this research study is to determine if the infusion of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in patients with symptomatic severe coronary ischemia(CI).
In this trial we will determine whether the combination stem cell treatment is safe, feasible and results in the development of mature stable and/or collateral vessels and improvement of cardiac function.
Coronary Ischemia (CI) is intractable angina due to severe coronary artery disease which can seriously decrease blood flow to the heart.
CI needs a comprehensive treatment since the condition will not improve on its own. The overall goal of the treatment is to increase blood flow to the heart and improve symptoms of angina.
The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriate blood supply to the heart.
Patients eligible to participate in this study are those suffering from severe blockages of the vessels of the heart and are not candidates for percutaneous revascularization or surgical procedures.
|Heart Disease Blocked Arteries Coronary Ischemia Coronary Disease Coronary Artery Disease Coronary Atherosclerosis||Biological: MESENDO Other: placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study for the Transfer of Bone Marrow-Derived Mononuclear and Mesenchymal StemCells Into the Myocardium for the Treatment of Severe Coronary Ischemia|
- Safety as measured by laboratory assessments, ecg and temperature. [ Time Frame: 2 weeks ]
- Efficacy as measured by SPECT scan, MUGA scan and 2D Echogradiogram [ Time Frame: 6 months ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
20 individuals will receive placebo.
For placebo, 3 ml of the 'Final Suspension Medium' which consists of Dulbecco's Phosphate Buffered Saline (DPBS), containing 5% human serum albumin will be transferred to a 5 ml syringe
Active combination autologous stem cell therapy. 40 individuals will receive MESENDO in either the "high" or "low" dose treatment groups.
For the cell product, proper aliquots of each cell type will be taken to fulfill the doses established for this protocol. The two aliquots will be mixed and resuspended to a final volume of 3 ml in the 'Final Suspension Medium' which consists of Dulbecco's Phosphate Buffered Saline (DPBS), containing 5% human serum albumin.
Enrolled individuals (60) will be divided in 2 Treatment groups for the infusion of the cell /placebo product:
- Treatment Group A (30 individuals, including patients and placebo controls) will receive the product by intracoronary infusion,
Treatment Group B (30 individuals, including patients and placebo controls) will receive the product by transendocardial injections.
In turn, each Treatment Group will consist of 2 subgroups of individuals that will receive the infusion of one of the two doses established of the cell product:
- In treatment SubGroup 1, 10 individuals will receive the "low dose" of the cell product and 5 individuals will receive the placebo product.
- In treatment SubGroup 2, 10 individuals will receive the "high dose" of the cell product and 5 individuals will receive the placebo product
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790764
|United States, Louisiana|
|TCA Cellular Therapy|
|Covington, Louisiana, United States, 70433|
|Principal Investigator:||Gabriel P. Lasala, MD||TCA Cellular Therapy|