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

Tracking Information
First Received Date ^ICMJE	March 20, 2008
Last Updated Date	December 9, 2008
Start Date ^ICMJE	February 2008
Estimated Primary Completion Date	August 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 25, 2008)	Safety as measured by laboratory assessments, ecg, temperature and holter monitor [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00643981 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 25, 2008)	Efficacy as measured by SPECT scan and 2-D Echo [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Combination Stem Cell Therapy for the Treatment of Severe Coronary Ischemia
Official Title ^ICMJE	Phase I Study to See if a of A Combination Stem Cell Therapy is Safe and Feasible for the Treatment of Severe Coronary Ischemia
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.
Detailed Description
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Coronary Ischemia Coronary Disease Coronary Artery Disease Coronary Atherosclerosis Coronary Arteriosclerosis
Intervention ^ICMJE	Biological: MESENDO
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	10
Estimated Completion Date	February 2009
Estimated Primary Completion Date	August 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00643981
Responsible Party	Gabriel P. Lasala, M.D., TCA Cellular Therapy, LLC
Study ID Numbers ^ICMJE	2007-03-I
Study Sponsor ^ICMJE	TCA Cellular Therapy
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	TCA Cellular Therapy
Verification Date	December 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP