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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Augusto Rojas-Martinez, M.D./D.Sc.
  • Phone Number: +52-81-82890404
  • Email: arojasmtz@gmail.com

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital y Clinica OCA, S.A. de C.V.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2009

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2010

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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