Combination Stem Cell (MESENDO) Therapy for Utilization and Rescue of Infarcted Myocardium
The purpose of this research study is to determine if the transplant of a combination of stem cells, obtained from the bone marrow of the same patient, is effective for utilization and rescue of infarcted myocardium. End points will be the assessment of development of mature and stable new blood vessels as well as improvement in cardiac function.
This, Phase I, single center, prospective, non-randomized, open-label study will evaluate the safety and feasibility of use of the proposed combination of autologous stem cells. Potential subjects who fulfill clinical and laboratory entry criteria at screening will undergo a process of bone marrow aspiration for preparation of the two types of bone marrow-derived stem /progenitor cells to use. The two bone marrow-derived cell types will be mixed and implanted to patients approximately 2 weeks after bone marrow aspiration. After transplant, patients will be have a 3 month follow-up to evaluate safety as well as functional heart improvement by analysis of symptoms, myocardial perfusion SPECT, and echocardiography.
Study population will include adult male and female subjects, ages 18-70, presenting with acute myocardial infarction and subjects who have had a recent (within 12 months) myocardial infarction and will undergo coronary artery bypass grafting.
Patients will be divided in two groups:
- the first group will enroll patients with acute myocardial infarction whom percutaneous coronary intervention restored myocardial flow after 4 hours or greater of the initiation of symptoms,
- the second group will enroll patients who are candidates for coronary artery bypass surgery and had a myocardial infarction in the past 12 months.
Patients will receive the cell mixture by intracoronary or intramyocardial infusion, respectively.
The rationale of this clinical study is based on the observation that most attempts using adult stem cells for myocardial regeneration have utilized a source of bone marrow derived progenitor cells with the potential to generate new blood vessel and thus contribute to the revascularization of the ischemic tissue. This therapy seems to be adequate but not sufficient, since it lacks a source of stem cells capable of differentiating and maturing into cardiac muscle cells, thus contributing to the recovery of local contractility. The proposed combination stem/progenitor cell therapy to be used in this protocol is aimed at contributing cell types capable of regenerating both blood vessels and muscle tissues damaged after MI.
Coronary Artery Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study to Determine the Safety and Feasibility of the Use of a Combination Stem Cell Therapy in Patients With Acute Myocardial Infarction|
- Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2007|
|Study Completion Date:||March 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Patients with documented acute myocardial infarction (heart attack) occurring within 4-24 hours after onset of symptoms
Intracoronary transplantation of autologous stem cells via balloon catheter
Candidates for coronary artery bypass grafting that suffered a myocardial infarction (heart attack) within the past 12 months
Intracardiac transplantation of autologous stem cells via direct injection
|United States, Louisiana|
|TCA Cellular Therapy, LLC|
|Covington, Louisiana, United States, 70433|
|Principal Investigator:||Gabriel P. Lasala, M.D.||TCA Cellular Therapy, LLC|