CD133+ Cell Therapy for Refractory Coronary Heart Disease

NCT01049867 | Unknown Phase 1

• 1 other identifier: CASOR01CMN093300CT051044-1895
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• Improvement in the heart failure functional class measured by NYHA and CCS classification tests.

  Base-line, 3, and 6 months

• Changes in the score of the "Minnessota living with heart failure score".

  Base-line, 3, and 6 months.

• Functional heart changes measured by spiroergometry.

  Base-line, 3, and 6 months.

• Reduction in the consumption of medicines for the heart ailment (nitrates, diuretics, etc.).

  Base-line, 3, and 6 months.

• Safety and compatibility through evaluation of adverse events (death, supraventricular and ventricular arrhythmias, brain/peripheral ischemic events, myocardial infarct, malignancies, etc.).

  Base-line, 3, and 6 months.

Interventions

Intracoronary Infusion of CD133+ Cells PROCEDURE

Single intracoronary infusion of a suspension consisting of 30 ml saline solution containing at least 1 million CD133+ endothelial precursor cells.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital y Clinica OCA, S.A. de C.V.: lead

Study Sites (1)

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

Monterrey, Nuevo León, 64000, Mexico

RECRUITING

Related Publications (32)

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MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Augusto Rojas-Martinez, M.D./D.Sc.

  Director, Cell Therapy Laboratory. OCA Hospital

  STUDY CHAIR

Central Study Contacts

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

CONTACT

+52-81-82890404; arojasmtz@gmail.com

Monica Rangel-Fuentes, M.D.

CONTACT

+52-81-82890404; mariam_fuentes@yahoo.com.mx

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 15, 2010
• Study Start: December 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: January 15, 2010

Record last verified: 2010-01

Locations

ME (1)