Coronary Artery Disease Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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