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CORD BLOOD: TREATMENT FOR ACUTE MYOCARDIAL INFARCTION

Award Number: R41HL077012
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/01/2005
PERIOD OF PERFORMANCE END DATE: 04/30/2006

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CORD BLOOD: TREATMENT FOR ACUTE MYOCARDIAL INFARCTION - DESCRIPTION (provided by applicant): Transplantation of human umbilical cord stem cells (hUCBC) has been shown to be effective in limiting infarct size and in the preservation of left ventricular function and anatomy in a rat model. These effects have been present in studies both utilizing and not utilizing immunosuppression. Whether immunosuppression will be required in a large animal model is unknown, as is the efficacy of transplantation of hUCBC in a large animal model. This data is critical in order to determine the risk:benefit ratio of this therapy, especially if immunosuppression is required; and in order to move this therapy into human clinical trials for the treatment of myocardial infarction and prevention of congestive heart failure which affects over 5 million patients in the U.S. This study is specifically designed to evaluate the effects of hUCBC transplantation following myocardial infarction on left ventricular function and anatomy and determine the necessity of immunosuppression in a porcine model. Forty-two animals will be studied; 6 animals will serve as controls (no myocardial infarction) and 36 animals will undergo myocardial infarction (MI). The MI group will consist of three (12 animals each) different treatment modalities (Group 1-no treatment, Group 2-treatment with Isolyte media injection into the infarct border zone, and Group 3-treatment with hUCBC injection into the infarct zone). Six animals in each treatment group will receive immunosuppression and six will receive no immunosuppression. Those animals that are designated for immunosuppression will receive cyclosporine 10 mg/kg twenty-four hours preoperatively and every day subsequently until sacrificed. The randomization will be blinded to pathologists, sonographers, and echocardiogram interpreters. LV function will be evaluated by echocardiography and invasive monitoring at 1, 2, and 4 wks and 2, 3, and 4 months. Animals will be sacrificed following evaluation and the heart tissue will be analyzed for infarct size, hUCBC engraftment, immunorejection, cardiac phenotype (using immunohistochemistry), and stem-cell derived endothelial cells. It is anticipated that the results from this study will assist in planning further studies for determination of the appropriate dosage, route, and timing of administration of hUCBC for the treatment of acute myocardial infraction to preserve left ventricular function and anatomy and prevent the development of congestive heart failure.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2005 ( Subtotal = $184,249 )
2005	2005	SANERON CCEL THERAPEUTICS INC	13101 TELECOM DRIVE	TAMPA	FL	33637	HILLSBOROUGH	USA	Blood Diseases and Resources Research	000	1	4/3/2005	NEW	$184,249
														Subtotal = $184,249

Grand Total All Awards = $184,249

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CORD BLOOD: TREATMENT FOR ACUTE MYOCARDIAL INFARCTION

Award Number: R41HL077012

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/01/2005

PERIOD OF PERFORMANCE END DATE: 04/30/2006

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