Combination Stem Cell Therapy for the Treatment of Severe Coronary Ischemia - Full Text View

Sponsored by:	TCA Cellular Therapy
Information provided by:	TCA Cellular Therapy
ClinicalTrials.gov Identifier:	NCT00643981

Purpose

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	Intervention	Phase
Coronary Ischemia Coronary Disease Coronary Artery Disease Coronary Atherosclerosis Coronary Arteriosclerosis	Biological: MESENDO	Phase I

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by TCA Cellular Therapy:

Primary Outcome Measures:

Safety as measured by laboratory assessments, ecg, temperature and holter monitor [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Efficacy as measured by SPECT scan and 2-D Echo [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643981

Locations

United States, Louisiana
TCA Cellular Therapy, LLC
Covington, Louisiana, United States, 70433

Sponsors and Collaborators

TCA Cellular Therapy

More Information

No publications provided

Responsible Party:	TCA Cellular Therapy, LLC ( Gabriel P. Lasala, M.D. )
Study ID Numbers:	2007-03-I
Study First Received:	March 20, 2008
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00643981 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Atherosclerosis
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Ischemia
Arteriosclerosis
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Atherosclerosis
Pathologic Processes
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Ischemia
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009