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Trial record 46 of 70 for:    stem cell peripheral arterial disease AND cell therapy

The Effects of External Counter Pulsation Therapy on Circulating Endothelial Progenitor Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00272571
Recruitment Status : Completed
First Posted : January 6, 2006
Last Update Posted : January 31, 2006
Information provided by:
Sheba Medical Center

Brief Summary:
The objectives of the study are to test the hypothesis that external counter pulsation therapy (ECPT) provides clinical benefit by improving the number and function of endothelial progenitor cells (EPCs) in peripheral blood of patients with angina pectoris.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: External counter pulsation therapy Not Applicable

Detailed Description:

ECPT is a non-invasive approach for increasing blood flow to the heart in patients with myocardial ischemia. ECPT produces beneficial effects in coronary artery disease (CAD) patients. However, the exact mechanisms of ECPT action are not defined yet. Evidence has now accumulated that bone marrow-derived cells with angiogenic capability, termed EPCs, circulate in the blood of adults. EPCs possess the ability to home to sites of ischemia and contribute to neoangiogenesis.

We prospectively study CAD patients [Canadian Cardiovascular Society (CCS) angina class II-IV], before and after ECPT , and compare them with age- and sex-matched controls. Peripheral blood CD34+ cells, EPCs (CD34/VEGFR2+ cells), EPC colony forming units (CFUs) and brachial artery endothelial function is assessed prior to and after ECPT. Percent improvement in endothelium-dependent brachial artery flow-mediated dilatation (%FMD) is assessed using high-resolution ultrasound.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of External Counter Pulsation Therapy (ECPT) on the Number and Function of Circulating Endothelial Progenitor Cells in Patients With Angina Pectoris
Study Start Date : August 2004
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Primary Outcome Measures :
  1. The number of circulating endothelial progenitor cells in peripheral blood (before and one week after treatment)

Secondary Outcome Measures :
  1. Brachial artery endothelial function (before and one week after treatment)
  2. CCS angina class (before and one week after treatment)

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • coronary artery disease
  • CCS angina class II-IV

Exclusion Criteria:

  • aortic regurgitation
  • acute myocardial infarction <3 months
  • systemic hypertension >180/110 mm
  • atrial fibrillation
  • deep vein thrombosis
  • phlebitis and hemorrhagic diathesis
  • pregnancy
  • abdominal aortic aneurism
  • metastatic tumor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00272571

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Neufeld cardiac research institute, Sheba medical center
Tel Hashomer, Israel
Sponsors and Collaborators
Sheba Medical Center
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Principal Investigator: Jonathan Leor, Prof. Chaim Sheba Medical Center

Layout table for additonal information Identifier: NCT00272571    
Other Study ID Numbers: SHEBA-02-2701-JL-CTIL
First Posted: January 6, 2006    Key Record Dates
Last Update Posted: January 31, 2006
Last Verified: January 2006
Keywords provided by Sheba Medical Center:
ECPT, endothelial progenitor cells
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases