CD133+ Cell Therapy for Refractory Coronary Heart Disease

January 13, 2010 updated by: Hospital y Clinica OCA, S.A. de C.V.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64000
        • Recruiting
        • Hospital y Clinica OCA, S.A de C.V.
        • Contact:
        • Contact:
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Base-line, 3, and 6 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in the heart failure functional class measured by NYHA and CCS classification tests.
Time Frame: Base-line, 3, and 6 months
Base-line, 3, and 6 months
Changes in the score of the "Minnessota living with heart failure score".
Time Frame: Base-line, 3, and 6 months.
Base-line, 3, and 6 months.
Functional heart changes measured by spiroergometry.
Time Frame: Base-line, 3, and 6 months.
Base-line, 3, and 6 months.
Reduction in the consumption of medicines for the heart ailment (nitrates, diuretics, etc.).
Time Frame: Base-line, 3, and 6 months.
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.).
Time Frame: Base-line, 3, and 6 months.
Base-line, 3, and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Chair: Augusto Rojas-Martinez, M.D./D.Sc., Director, Cell Therapy Laboratory. OCA Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2010

Study Completion (ANTICIPATED)

June 1, 2011

Study Registration Dates

First Submitted

January 13, 2010

First Submitted That Met QC Criteria

January 13, 2010

First Posted (ESTIMATE)

January 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 15, 2010

Last Update Submitted That Met QC Criteria

January 13, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASOR01CMN093300CT051044-1895 (OTHER: COFEPRIS, Mexican Secretariat of Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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