CD133+ Cell Therapy for Refractory Coronary Heart Disease

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01049867
• Other study ID #: CASOR01CMN093300CT051044-1895
• Secondary ID: CASOR01CMN093300
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: January 13, 2010
• Last updated: January 13, 2010
• Start date: December 2009
• Est. completion date: June 2011

Study information

• Verified date: January 2010
• Source: Hospital y Clinica OCA, S.A. de C.V.
• Contact: Augusto Rojas-Martinez, M.D./D.Sc.
• Phone: +52-81-82890404
• Email: arojasmtz[@]gmail.com
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Mexico	Hospital y Clinica OCA, S.A de C.V.	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Hospital y Clinica OCA, S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Improvement in the heart failure functional class measured by NYHA and CCS classification tests.		Base-line, 3, and 6 months	No
Secondary	Changes in the score of the "Minnessota living with heart failure score".		Base-line, 3, and 6 months.	No
Secondary	Functional heart changes measured by spiroergometry.		Base-line, 3, and 6 months.	No
Secondary	Reduction in the consumption of medicines for the heart ailment (nitrates, diuretics, etc.).		Base-line, 3, and 6 months.	No
Secondary	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.	Yes