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Adipose-Derived Stromal/Stem Cell Therapy for Pressure Ulcers

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2012 / SBIR
Agency Tracking Number:
R43AG042904
Solicitation Year:
2012
Solicitation Topic Code:
NIA
Solicitation Number:
AG12-009
Small Business Information
LACELL, LLC
340 BLDG, LSU CAMPUS, EAST PARKER AVE. BATON ROUGE, LA 70803-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2012
Title: Adipose-Derived Stromal/Stem Cell Therapy for Pressure Ulcers
Agency: HHS
Contract: 1R43AG042904-01
Award Amount: $185,959.00
 

Abstract:

DESCRIPTION (provided by applicant): This Phase I SBIR, responding to RFA-AG-12-009 entitled T1 Translational Research on Aging from the NIA, explores novel cell-based therapeutic approaches to the treatment of pressure ulcers and full thickness skin wounds in the elderly. Although it is well established that the prevention of pressure ulcers requires labor- intensive nursing care, patients in assisted living centers and nursing homes remain at high risk for developing pressure ulcers. In fact, over 70%of pressure ulcers occur in Americans over the age of 70 and their hospital costs exceed 11 billion annually. Current treatment of pressure ulcers relies primarily on surgical debridement, hyperbaric oxygen, growth factors, and negative pressure devices.This proof of principle study will use a murine model to test LaCell's hypothesis that adipose-derived stromal/stem cell (ASC) therapy will accelerate and improve pressure ulcer healing in the elderly. Studies will be conducted in young (3-4 month) and old (24 month) C57Bl/6 male mice using leptin receptor deficient (db/db) obese diabetic mice (3-4 month) as positive controls. Bilateral full thickness skin wounds will be created dorsally on each mouse. These will be protected by a silicon splint in theshape of a donut to prevent spontaneous retraction of the wound edges. This will allow for accurate measurements of the wound epithelialization and healing rates. Adipose stromal/stem cells (ASC) will be isolated from C57Bl/6 mice transgenic for the greenfluorescent protein (GFP). In each animal, GFP+ ASC will be injected into the wound bed of one full thickness defect while the corresponding wound, injected with phosphate buffered saline, will serve as a control. Groups of animals will be harvested after1, 3, and 10 days post-operatively. Quantitative experimental outcomes will address the mechanisms underlying the ASC impact on repair that will include rates of epithelialization, wound closure, cytokine and matrix metalloproteinase expression, and immune cell infiltration. These outcomes will determine the feasibility and efficacy of ASC based therapies to accelerate the repair of pressure ulcers and full thickness skin wounds in the elderly. Phase I will lay the foundation for future pharmacokinetic andtoxicological testing of both murine and human ASC in Phase II studies. Additionally, they will provide the basis for detailed pre-IND discussions with the Food and Drug Administration. LaCell LLC is a biotechnology company founded by leading investigators and inventors in the application of adipose stromal/stem cells to regenerative medicine. As consultants, LaCell has enlisted the assistance of experts in the field of plastic surgery and wound healing. PUBLIC HEALTH RELEVANCE: The elderly are athigh risk for the development of pressure ulcers, a debilitating and life threatening condition that remains a major health care burden in the U.S. LaCell proposes to develop an adipose stromal/stem cell therapy for pressure ulcers. This approach has thepotential to accelerate and improve the rate of wound closure and long-term recovery. The outcomes of this focused proof of principle pre-clinical study have relevance to a clinical issue of unique importance to geriatric medicine in the U.S. and abroad. With its background in adipose stromal/stem cell biotechnology, LaCell and its consultants are uniquely positioned to address this unmet medical need.

Principal Investigator:

Xiying Wu
225-763-9572
xiyingwu77@yahoo.com

Business Contact:

Xiying W. Md
225-763-9572
xiyingwu77@yahoo.com
Small Business Information at Submission:

LACELL, LLC
340 BLDG, LSU CAMPUS, EAST PARKER AVE. BATON ROUGE, LA 70803-

EIN/Tax ID: 127205525
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No