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Phase 2 Study of Selective Cytopheretic Device for the Treatment of Pediatric Patients with Acute Kidney Injury

Award Number: R01FD005092
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/10/2015
PERIOD OF PERFORMANCE END DATE: 07/30/2019

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Phase 2 Study of Selective Cytopheretic Device for the Treatment of Pediatric Patients with Acute Kidney Injury - DESCRIPTION (provided by applicant): Acute kidney injury (AKI) and septic shock associated AKI (SSAKI) requiring renal replacement therapy (RRT) are significant complications in intensive care unit (ICU) patients with an associated mortality rate exceeding 50%. The need for novel therapeutics that are specifically approved for pediatric AKI/RRT use is driven by the nearly 50% mortality rates of pediatric patients with this disorder. The SCD is a novel device containing bundled biomimetic polysulfone fibers which selectively bind/sequester and deactivate leukocytes (LE) in a dialysis extracorporeal blood circuit, resulting in an immunomodulatory effect in the systemic inflammatory response associated with AKI and SSAKI. The SCD, combined with regional citrate anticoagulation, is a novel therapeutic application utilizing biocompatible membranes that allow LE attachment in a calcium low environment during regional citrate anticoagulation resulting in a diminution in the LE activated state. The SCD has been studied in prior clinical trials of AKI. This proposal will study the safety and efficacy of SCD therapy in pediatric patients with AKI requiring CRRT therapy. Specific Aim 1 will evaluate this innovative approach in pediatric ICU patients of greater than 20 kilograms (kg) in body weight. Specific Aim 2 will assess this approach in pediatric patients with body weights between 8 and 20 kg utilizing a SCD one-fifth the size of the current SCD.


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: 2019 ( Subtotal = -$221,086 )
2019	2018	INNOVATIVE BIOTHERAPIES, INC.	650 AVIS DR # 300	ANN ARBOR	MI	48108	WASHTENAW	USA	Food and Drug Administration Research	001	3	8/7/2019	NON-COMPETING CONTINUATION	-$43,308
2019	2018	INNOVATIVE BIOTHERAPIES, INC.	650 AVIS DR # 300	ANN ARBOR	MI	48108	WASHTENAW	USA	Food and Drug Administration Research	000	3	8/2/2019	NON-COMPETING CONTINUATION	-$177,778
														Subtotal = -$221,086

Issue Date FY: 2018 ( Subtotal = $398,864 )
2018	2018	INNOVATIVE BIOTHERAPIES, INC.	650 AVIS DR # 300	ANN ARBOR	MI	48108	WASHTENAW	USA	Food and Drug Administration Research	000	3	4/11/2018	NON-COMPETING CONTINUATION	$398,864
														Subtotal = $398,864

Issue Date FY: 2017 ( Subtotal = $399,483 )
2017	2017	INNOVATIVE BIOTHERAPIES, INC.	650 AVIS DR # 300	ANN ARBOR	MI	48108	WASHTENAW	USA	Food and Drug Administration Research	000	2	3/24/2017	NON-COMPETING CONTINUATION	$399,483
														Subtotal = $399,483

Issue Date FY: 2016 ( Subtotal = $0 )
2016	2015	INNOVATIVE BIOTHERAPIES INC	650 AVIS DRIVE	ANN ARBOR	MI	48108	WASHTENAW	USA	Food and Drug Administration Research	000	1	8/15/2016	NEW	$0
														Subtotal = $0

Issue Date FY: 2015 ( Subtotal = $399,132 )
2015	2015	INNOVATIVE BIOTHERAPIES INC	401 WEST MORGAN ROAD	ANN ARBOR	MI	48108	WASHTENAW	USA	Food and Drug Administration Research	000	1	9/7/2015	NEW	$399,132
														Subtotal = $399,132

Grand Total All Awards = $976,393

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Phase 2 Study of Selective Cytopheretic Device for the Treatment of Pediatric Patients with Acute Kidney Injury

Award Number: R01FD005092

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/10/2015

PERIOD OF PERFORMANCE END DATE: 07/30/2019

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