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AUTOLOGOUS CD34+ CELL THERAPY FOR THERAPEUTIC ANGIOGENESIS IN ADVANCED PAD

Award Number: R01HL077428
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2006
PERIOD OF PERFORMANCE END DATE: 12/31/2011

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AUTOLOGOUS CD34+ CELL THERAPY FOR THERAPEUTIC ANGIOGENESIS IN ADVANCED PAD - DESCRIPTION (provided by applicant): The age-adjusted prevalence of peripheral arterial disease (PAD) in the U.S. population has been estimated to approach 12%. The clinical consequences of occlusive PAD include pain on walking (claudication), pain at rest, and loss of tissue integrity in the distal limbs; the latter may ultimately lead to amputation of a portion of the lower extremity. Surgical bypass techniques and percutaneous catheter-based interventions may be used to successfully revascularize the limbs of certain patients with PAD. In many patients, however, the anatomic extent and distribution of arterial occlusion is too severe to permit relief of pain and/or healing of ischemic ulcers. No effective medical therapy is available for the treatment of such patients, for many of whom amputation represents the only hope for alleviation of symptoms. The ultimate failure of medical treatment and mechanical revascularization in significant numbers of patients has led to attempts to develop alternative therapies for ischemic disease. These strategies include administration of angiogenic cytokines, either as recombinant protein or as gene therapy, and more recently, to investigations of cell therapy. The concept that new blood vessel formation could be augmented by administering bone marrow cells or circulating endothelial progenitor cells (EPCs) is based upon work performed in our laboratory and others in the past 7 years. The purpose of this pilot clinical protocol is to investigate the efficacy and safety of intramuscular injection of autologously derived EPCs in patients with PAD as a means of augmenting blood vessel formation and perfusion. The rationale for this human protocol is based upon preclinical studies performed in our laboratory and detailed in this application. The completion of the proposed studies will provide data regarding the safety and efficacy of EPC therapy necessary for the design of larger randomized trials and will also provide valuable insights regarding treatment of ischemic disease with a cell based approach.


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: 2011 ( Subtotal = $330,725 )
2011	2011	NORTHWESTERN UNIVERSITY	633 CLARK STREET	EVANSTON	IL	60208	COOK	USA	Cardiovascular Diseases Research	000	5	12/21/2010	NON-COMPETING CONTINUATION	$330,725
														Subtotal = $330,725

Issue Date FY: 2010 ( Subtotal = $543,964 )
2010	2010	NORTHWESTERN UNIVERSITY	633 CLARK STREET	EVANSTON	IL	60208	COOK	USA	Cardiovascular Diseases Research	001	4	2/26/2010	NON-COMPETING CONTINUATION	$44,405
2010	2010	NORTHWESTERN UNIVERSITY	633 CLARK STREET	EVANSTON	IL	60208	COOK	USA	Cardiovascular Diseases Research	000	4	1/8/2010	NON-COMPETING CONTINUATION	$499,559
														Subtotal = $543,964

Issue Date FY: 2009 ( Subtotal = $0 )
2009	2008	NORTHWESTERN UNIVERSITY	633 CLARK STREET	EVANSTON	IL	60201	COOK	USA	Cardiovascular Diseases Research	000	3	4/10/2009	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2008 ( Subtotal = $529,972 )
2008	2008	NORTHWESTERN UNIVERSITY	633 CLARK STREET	EVANSTON	IL	60201	COOK	USA	Cardiovascular Diseases Research	000	3	2/27/2008	NON-COMPETING CONTINUATION	$529,972
														Subtotal = $529,972

Issue Date FY: 2007 ( Subtotal = $526,922 )
2007	2007	NORTHWESTERN UNIVERSITY	633 CLARK STREET	EVANSTON	IL	60201	COOK	USA	Cardiovascular Diseases Research	000	2	8/13/2007	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$526,922
														Subtotal = $526,922

Issue Date FY: 2006 ( Subtotal = $570,336 )
2006	2006	CARITAS ST ELIZABETH`S MEDICAL CENTER OF BOSTON	736 CAMBRIDGE ST, BOX OLH-6BD	BOSTON	MA	02135	SUFFOLK	USA	Cardiovascular Diseases Research	000	1	1/20/2006	NEW	$570,336
														Subtotal = $570,336

Grand Total All Awards = $2,501,919

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AUTOLOGOUS CD34+ CELL THERAPY FOR THERAPEUTIC ANGIOGENESIS IN ADVANCED PAD

Award Number: R01HL077428

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 02/01/2006

PERIOD OF PERFORMANCE END DATE: 12/31/2011

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