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CD133+ Cell Therapy for Refractory Coronary Heart Disease

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ClinicalTrials.gov Identifier: NCT01049867
Recruitment Status : Unknown
Verified January 2010 by Hospital y Clinica OCA, S.A. de C.V..
Recruitment status was:  Recruiting
First Posted : January 15, 2010
Last Update Posted : January 15, 2010
Information provided by:
Hospital y Clinica OCA, S.A. de C.V.

Brief Summary:
The aim of this study is to evaluate if the intracoronary infusion of autologous bone-marrow derived CD133+ endothelial precursor cells is able to promote neovascularization and to improve myocardial perfusion and contractility in patients with refractory coronary heart disease, characterized by poor response to standard coronary interventions, severe impairment of the quality of life, and poor prognosis.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Intracoronary Infusion of CD133+ Cells Phase 1 Phase 2

Detailed Description:
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 studies.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1-2 Study of Intracoronary Infusion of CD133+ Endothelial Precursor Cells for Patients With Coronary Heart Disease in Selected Obstructed Artery
Study Start Date : December 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Procedure: Intracoronary Infusion of CD133+ Cells
    Single intracoronary infusion of a suspension consisting of 30 ml saline solution containing at least 1 million CD133+ endothelial precursor cells.

Primary Outcome Measures :
  1. Increased regional and global myocardial contractility measured by low-dose dobutamine echocardiography/MRI and increased myocardial perfusion measured by adenosine nuclear stress testing. [ Time Frame: Base-line, 3, and 6 months. ]

Secondary Outcome Measures :
  1. Improvement in the heart failure functional class measured by NYHA and CCS classification tests. [ Time Frame: Base-line, 3, and 6 months ]
  2. Changes in the score of the "Minnessota living with heart failure score". [ Time Frame: Base-line, 3, and 6 months. ]
  3. Functional heart changes measured by spiroergometry. [ Time Frame: Base-line, 3, and 6 months. ]
  4. Reduction in the consumption of medicines for the heart ailment (nitrates, diuretics, etc.). [ Time Frame: Base-line, 3, and 6 months. ]
  5. Safety and compatibility through evaluation of adverse events (death, supraventricular and ventricular arrhythmias, brain/peripheral ischemic events, myocardial infarct, malignancies, etc.). [ Time Frame: Base-line, 3, and 6 months. ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 surgery.
  • 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 Kardiologie)
  • 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 administration.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049867

Contact: Augusto Rojas-Martinez, M.D./D.Sc. +52-81-82890404 arojasmtz@gmail.com
Contact: Monica Rangel-Fuentes, M.D. +52-81-82890404 mariam_fuentes@yahoo.com.mx

Hospital y Clinica OCA, S.A de C.V. Recruiting
Monterrey, Nuevo Leon, Mexico, 64000
Contact: Augusto Rojas-Martinez, M.D./D.Sc.    +52-81-82890404    arojasmtz@gmail.com   
Contact: Monica Rangel-Fuentes, M.D.    +52-81-82890404    mariam_fuentes@yahoo.com.mx   
Principal Investigator: Ramiro Flores-Ramirez, M.D.         
Sub-Investigator: Armando Garcia-Castillo, M.D.         
Sub-Investigator: Artemio Uribe-Longoria, M.D.         
Sub-Investigator: Monica Rangel-Fuentes, M.D.         
Sub-Investigator: Jose H. Treviño-Ortiz, M.D.         
Sub-Investigator: Rosario Salazar-Riojas, M.Sc.         
Sub-Investigator: Genoveva J. Benavides-Chereti, M.Sc.         
Sub-Investigator: Adelina Hernandez-Hurtado, M.Sc.         
Sub-Investigator: Luciana Espinosa-Oliveros, M.D.         
Sponsors and Collaborators
Hospital y Clinica OCA, S.A. de C.V.
Study Chair: Augusto Rojas-Martinez, M.D./D.Sc. Director, Cell Therapy Laboratory. OCA Hospital


Responsible Party: Dr. Genaro Levinson/Director, Hospital y Clinica OCA, S.A. de C.V.
ClinicalTrials.gov Identifier: NCT01049867     History of Changes
Other Study ID Numbers: CASOR01CMN093300CT051044-1895
CASOR01CMN093300CT051044-1895 ( Other Identifier: COFEPRIS, Mexican Secretariat of Health )
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: January 15, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases