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Phase 1-2 Study of Intracoronary Infusion of CD133+ Endothelial Precursor Cells for Patients With Coronary Heart Disease in Selected Obstructed Artery

Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Coronary Artery Disease

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Trial Information

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

Inclusion Criteria:

- Patients with proven CHD by coronary angiography demonstrating occlusion or extreme
stenosis (> 90%) of a coronary artery (target artery) not suitable for angioplasty or

- Angiographic criteria: Feasibility for balloon catheter placement without risks of
obstruction of the left main coronary trunk.

- Evidence of viable myocardial tissue in the area irrigated by the target artery by
MRI (low dose dobutamine and late enhancement).

- CCS class 2-4 angina pectoris (angina pectoris at rest and at light exertion, obvious
reduction in the exertion capacity).

- Optimal antianginal pharmacologic therapy (consistent with the current guidelines of
ACC (American College of Cardiology), as well as the DGK (Deutsche Gesellschaft für

- Signed written consent form accepted by the Ethics Committee.

- Effective contraception in women of child-bearing age.

Exclusion Criteria:

- Severe symptomatic heart failure (NYHA class 4).

- Myocardial aneurysm (in the target region) without evidence of viable myocardium.

- Myocardial infarction in the last 4 weeks.

- Symptomatic ventricular tachycardia.

- Known malignancy.

- Known hematological disease.

- Renal insufficiency with creatinine > 2.5 mg/dl.

- Pregnancy.

- Active chronic inflammatory bowel disease or rheumatic disease with high parameters
of inflammation (WBCs above 10/nl and increased C-reactive protein). Systemic steroid

- Severe coagulopathy or phenprocoumon type anticoagulation therapy at the time of bone
marrow extraction.

- Antiproliferative therapy (chemotherapy, etc.).

- Non accordance with procedures and follow-up studies.

- Contraindications to MRI studies.

- Known hypersensitivity against mouse immunoglobulins.

- Known hypersensitivity against ferridextran.

- Contraindications for bone marrow extraction.

- Cerebrovascular accident in the past four months.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Increased regional and global myocardial contractility measured by low-dose dobutamine echocardiography/MRI and increased myocardial perfusion measured by adenosine nuclear stress testing.

Outcome Time Frame:

Base-line, 3, and 6 months.

Safety Issue:


Principal Investigator

Augusto Rojas-Martinez, M.D./D.Sc.

Investigator Role:

Study Chair

Investigator Affiliation:

Director, Cell Therapy Laboratory. OCA Hospital


Mexico: Federal Commission for Sanitary Risks Protection

Study ID:




Start Date:

December 2009

Completion Date:

June 2011

Related Keywords:

  • Coronary Artery Disease
  • Coronary Artery Disease
  • Myocardial Ischemia
  • Coronary Disease
  • Heart Diseases