Phase 1-2 Study of Intracoronary Infusion of CD133+ Endothelial Precursor Cells for Patients With Coronary Heart Disease in Selected Obstructed Artery
Refractory Coronary Artery Disease is a significant cause of mortality and decreased quality
of life. Intracoronary infusion of CD133+ progenitor cells is a viable treatment option for
patients with this condition. After clinical and laboratory evaluation, 50-100 ml of bone
marrow will be obtained by bone marrow aspiration from the posterior iliac crest under local
anesthesia. From this sample, CD133+ endothelial progenitor cells will be isolated, purified
and packed within the next 12 hours of extraction, and resuspended in 30 ml saline solution.
The patient will undergo coronary catheterization for selection of the target obstructed
artery for cell infusion, which will be performed using a balloon catheter under hemodynamic
monitoring. Once concluded, the patient will be transferred to intermediate care unit for
post-interventional observation for approximately 24 hours before being released. Ambulatory
follow-up will be performed at specific intervals to determine efficacy and safety of this
intervention by clinical and laboratory examination, including imaging and cardiac function
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Increased regional and global myocardial contractility measured by low-dose dobutamine echocardiography/MRI and increased myocardial perfusion measured by adenosine nuclear stress testing.
Base-line, 3, and 6 months.
Augusto Rojas-Martinez, M.D./D.Sc.
Director, Cell Therapy Laboratory. OCA Hospital
Mexico: Federal Commission for Sanitary Risks Protection