We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Combination Stem Cell Therapy for the Treatment of Severe Coronary Ischemia (CI)

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.
 
ClinicalTrials.gov Identifier: NCT00643981
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : April 28, 2011
Sponsor:
Information provided by:
TCA Cellular Therapy

Brief Summary:

The purpose of this research study is to determine if the infusion of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in patients with symptomatic severe coronary ischemia. In this trial we will study the safe use of this therapy and its effects on making new blood vessels will be evaluated.

Coronary ischemia is intractable angina due to severe coronary artery disease which can seriously decrease blood flow to the heart.

CI needs a comprehensive treatment since the condition will not improve on its own. The overall goal of the treatment is to increase blood flow to the heart and improve symptoms of angina.

The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriate blood supply to the heart.

Patients eligible to participate in this study are those suffering from severe blockages to the vessels of the heart and are not candidates for percutaneous revascularization or surgical procedures.

Once the final mixture of stem cells is prepared, the cells will be intracoronary infused through a catheter into the blocked vessel of the heart.

Studies will be performed to evaluate if the intracoronary infusion of stem cells is safe, feasible and works.

Patients will be evaluated for 6 months after cell transplant.


Condition or disease Intervention/treatment Phase
Coronary Ischemia Coronary Disease Coronary Artery Disease Coronary Atherosclerosis Coronary Arteriosclerosis Biological: MESENDO Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study to See if a of A Combination Stem Cell Therapy is Safe and Feasible for the Treatment of Severe Coronary Ischemia
Study Start Date : February 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : February 2009

Intervention Details:
  • Biological: MESENDO
    2 ml of the "final cell mixture" will be injected through the lumen of an intracoronary percutaneous balloon designed for angioplasty into the ishcemic vessel.


Primary Outcome Measures :
  1. Safety as measured by laboratory assessments, ecg, temperature and holter monitor [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Efficacy as measured by SPECT scan and 2-D Echo [ Time Frame: 6 months ]


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female age 18-20
  • Angina Pectoris: CCS Class II or IV or angina symptom equivalent
  • 70% blockage in at least one epicardial vessel documented within 6 months
  • Stable medical therapy
  • Reversible perfusion defects by SPECT
  • Not a candidate for percutaneous intervention or coronary by-pass surgery

Exclusion Criteria:

  • Previous angiogenic therapy or myocardial laser therapy
  • Severe valvular heart disease
  • Recent malignancy or radiation therapy within 6 months
  • Renal insufficiency with creatinine greater that 2.7
  • White blood count greater than 13,000 or lower than 3,000
  • Platelet count lower than 60,000 or higher that 500,000
  • Pregnant or planning to become pregnant
  • History of skeletal muscle disease
  • AST or ALT greater than two times upper limit of normal

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 ClinicalTrials.gov identifier (NCT number): NCT00643981


Locations
Layout table for location information
United States, Louisiana
TCA Cellular Therapy, LLC
Covington, Louisiana, United States, 70433
Sponsors and Collaborators
TCA Cellular Therapy
Layout table for additonal information
Responsible Party: Gabriel P. Lasala, M.D., TCA Cellular Therapy, LLC
ClinicalTrials.gov Identifier: NCT00643981    
Other Study ID Numbers: 2007-03-I
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: April 28, 2011
Last Verified: December 2008
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Arteriosclerosis
Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes