CD133+ Cell Therapy for Refractory Coronary Heart Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Hospital y Clinica OCA, S.A. de C.V..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital y Clinica OCA, S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT01049867
First received: January 13, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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 Intervention Phase
Coronary Artery Disease
Procedure: Intracoronary Infusion of CD133+ Cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hospital y Clinica OCA, S.A. de C.V.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in the heart failure functional class measured by NYHA and CCS classification tests. [ Time Frame: Base-line, 3, and 6 months ] [ Designated as safety issue: No ]
  • Changes in the score of the "Minnessota living with heart failure score". [ Time Frame: Base-line, 3, and 6 months. ] [ Designated as safety issue: No ]
  • Functional heart changes measured by spiroergometry. [ Time Frame: Base-line, 3, and 6 months. ] [ Designated as safety issue: No ]
  • Reduction in the consumption of medicines for the heart ailment (nitrates, diuretics, etc.). [ Time Frame: Base-line, 3, and 6 months. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: December 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01049867

Contacts
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

Locations
Mexico
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.
Investigators
Study Chair: Augusto Rojas-Martinez, M.D./D.Sc. Director, Cell Therapy Laboratory. OCA Hospital
  More Information

Publications:

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
Study First Received: January 13, 2010
Last Updated: January 13, 2010
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

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

ClinicalTrials.gov processed this record on July 24, 2014