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THERAPEUTIC POTENTIAL OF EX VIVO EXPANDED HUMAN CORD BLOOD DERIVED CD133+ CELLS I

Award Number: R44HL092706
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/19/2008
PERIOD OF PERFORMANCE END DATE: 03/31/2012

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THERAPEUTIC POTENTIAL OF EX VIVO EXPANDED HUMAN CORD BLOOD DERIVED CD133+ CELLS I - DESCRIPTION (provided by applicant): Critical Limb Ischemia (CLI) is a common problem that often results in major limb amputation. Circulating endothelial progenitor cells likely play a role in the pathogenesis of CLI; the number and function of these cells that are mobilized from the bone marrow are reduced in the elderly and diabetics, groups at high risk for CLI. Allogenic Umbilical Cord Blood (UCB) derived CD133+ hemangioblasts demonstrate greater activity for stimulating angiogenesis. However, there are no clinical trials of UCB-derived cell lines for CLI and the number of cells available from a cord sample is limited. The long-term objective is to develop a clinically relevant approach, through nanomaterials engineering, to efficiently expand human allogenic UCB derived CD133+ hemangioblasts and to demonstrate the biologic and therapeutic feasibility to treat CLI. In this proposed study, Specific Aim I will optimize clinical grade nanofiber scaffold ex vivo expansion of UCB derived CD133+ hemangioblasts from fresh and cryopreserved UCBs in a Good Manufacturing Practice (GMP) based cell culture and production facility. Specific Aim IIa will test survival of the expanded UCB allograft in a Histocompatibility Leukocyte Antigen (HLA)-matched, unrelated, non-immunosuppressed recipients. To test this aim 5 women with CLI will undergo implantation of HLA matched, gender mismatched UCB-derived cells subcutaneously with biopsy of the delivery site used to determine cell survival. To identify transplanted cells the specimens will be examined for viable Y-chromosome bearing cells using the Fluorescent in situ hybridization techniques (FISH). Specific Aim IIb will establish the therapeutic potential of the expanded HLA matched UCB allograft as a strategy to improve tissue perfusion in CLI. To test this aim 10 patients with CLI will receive HLA matched, ex vivo expanded, UCB-derived cells injected into the affected limb. This Aim will have 80% power to detect a 10 mmHg improvement in Transcutaneous Oxygen Pressure (TcPO2). PUBLIC HEALTH RELEVANCE: The overall objective of this project is to demonstrate the safety and efficacy of injecting ex vivo expanded allogeneic (from other people) umbilical cord blood-derived stem cells (CD133+ cells) for the treatment of critical limb ischemia (CLI). By providing enough blood supply to the ischemic limb, Arteriocyte hopes to observe reduced rest pain, increased exercise capacity, increased skin surface oxygen pressure and improved ulcer healing in the CLI patients. Arteriocyte believes through its stem cell therapy, patients with CLI will benefit from functional improvement, lower amputation risks, and save significant healthcare costs associated with CLI.


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 = $586,833 )
2011	2011	ARTERIOCYTE INC	11000 CEDAR AVENUE	CLEVELAND	OH	44106	CUYAHOGA	USA	Blood Diseases and Resources Research	000	3	3/14/2011	NON-COMPETING CONTINUATION	$586,833
														Subtotal = $586,833

Issue Date FY: 2010 ( Subtotal = $1,609,381 )
2010	2010	ARTERIOCYTE INC	11000 CEDAR AVENUE	CLEVELAND	OH	44106	CUYAHOGA	USA	Blood Diseases and Resources Research	000	2	3/24/2010	EXTENSION WITH OR WITHOUT FUNDS	$1,609,381
														Subtotal = $1,609,381

Issue Date FY: 2008 ( Subtotal = $281,794 )
2008	2008	ARTERIOCYTE INC	11000 CEDAR AVENUE	CLEVELAND	OH	44106	CUYAHOGA	USA	Blood Diseases and Resources Research	000	1	9/19/2008	NEW	$281,794
														Subtotal = $281,794

Grand Total All Awards = $2,478,008

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THERAPEUTIC POTENTIAL OF EX VIVO EXPANDED HUMAN CORD BLOOD DERIVED CD133+ CELLS I

Award Number: R44HL092706

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/19/2008

PERIOD OF PERFORMANCE END DATE: 03/31/2012

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