CD133+ Cell Therapy for Refractory Coronary Heart Disease

NCT ID: NCT01049867

Last Updated: 2010-01-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2011-06-30

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.

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital y Clinica OCA, S.A. de C.V.

OTHER

Sponsor Role: lead

Responsible Party

Hospital y Clinica OCA, S.A. de C.V.

Principal Investigators

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

Role: STUDY_CHAIR

Director, Cell Therapy Laboratory. OCA Hospital

Locations

Hospital y Clinica OCA, S.A de C.V.

Monterrey, Nuevo León, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

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

Role: CONTACT

arojasmtz@gmail.com

+52-81-82890404

Monica Rangel-Fuentes, M.D.

Role: CONTACT

mariam_fuentes@yahoo.com.mx

+52-81-82890404

Facility Contacts

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

Role: primary

arojasmtz@gmail.com

+52-81-82890404

Monica Rangel-Fuentes, M.D.

Role: backup

mariam_fuentes@yahoo.com.mx

+52-81-82890404

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Other Identifiers

CASOR01CMN093300CT051044-1895

Identifier Type: OTHER

Identifier Source: secondary_id

CASOR01CMN093300CT051044-1895

Identifier Type: -

Identifier Source: org_study_id