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Mechanical Activation of Adipose-Derived Stem Cells for the Treatment of Diabetic Foot Ulcers Using a Novel CD-Microfluidic Device

Award Number: R43DK116389
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Project Summary/Abstract The diabetic foot ulcer is the leading cause of nontraumatic lower limb amputations and carries the potential to dramatically affect the lives of 148 million individuals by the year 2035. The current standard of care includes physical offloading and surgical debridement, while newer allogeneic cell-based therapies are riddled with high costs and unpredictable outcomes. Emerging research has identified adipose-derived autologous stem cells as a potent therapeutic for safe and effective treatment of this lifestyle-limiting condition. Here, we propose a point-of-care closed system device that creates a ‘minimally manipulated’ adipose tissue therapeutic that can then be reinjected back into the patient for the treatment of this lifestyle-debilitating complication, all in a matter of minutes. Our device incorporates a novel centrifugation platform and a unique microfluidic channel design that shears and stimulates inherent stem cell populations found in adipose tissue. This concept of shear-stress activation is of particular importance in the setting of diabetes due to the fact that diabetic adipose-derived stem cells exhibit greatly reduced function when compared to healthy adipose tissue. Additionally, our device carries significant potential for a precision medicine approach to creating autologous therapeutics, in that the amount of shear-stress applied by our device leads to dose-dependent increase in various stem cell markers and subpopulations. With this grant we will optimize the parameters of our device to generate a therapeutic that enriches and activates adipose-derived stem cell populations critical to diabetic wound healing. Once we identify the shear-stress that generates the highest proportion of regenerative populations while maximizing the safety profile of this tissue, we will test the stem cells in various culture conditions to demonstrate the mechanisms by which wound healing take place. Subsequently, we will examine this optimized therapeutic in an animal model to demonstrate the superiority of this enriched/activated therapeutic when compared to unprocessed adipose tissue from the same source. This study will generate sufficient in vitro and in vivo evidence that should propel us to a phase II study where we will further evaluate the safety and efficacy of the therapeutic generated by our device in various clinical models of diabetes. Our multidisciplinary team includes surgeons, biomedical engineers, business executives and regulatory experts that will significantly increase the likelihood of a successful product that adheres to the highest scientific, clinical and business standards upheld by the Food and Drug Administration.


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: 2020 ( Subtotal = $0 )
2020	2017	SYNTR HEALTH TECHNOLOGIES, LLC	18806 SOUTH PRADO CT	CERRITOS	CA	90703	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	1/6/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $300,000 )
2017	2017	SYNTR HEALTH TECHNOLOGIES, LLC	18806 SOUTH PRADO CT	CERRITOS	CA	90703	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/13/2017	NEW	$300,000
														Subtotal = $300,000

Grand Total All Awards = $300,000

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Mechanical Activation of Adipose-Derived Stem Cells for the Treatment of Diabetic Foot Ulcers Using a Novel CD-Microfluidic Device

Award Number: R43DK116389

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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