Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

Cartilage Regeneration with Tunable Inflammation Resistance

Award Number: R44AG059310
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2017
PERIOD OF PERFORMANCE END DATE: 05/31/2026

Group Awards By:

View Award Description

Cartilage Regeneration with Tunable Inflammation Resistance - Abstract: Femoroacetabular impingement or FAI is a commonly diagnosed condition affecting a younger patient population than the general osteoarthritis (OA) population. Untreated, FAI invariably leads to OA and, ultimately, total hip arthroplasty (THA). The fact that most FAI diagnoses are made in patients under the age of 40, with many in their late teens and twenties, makes FAI all the more clinically challenging to treat. Due to the limited life span of currently available hip implants, hip replacement in younger patients most often will require at least one and possibly several revision surgeries later in life. Each revision surgery leaves the hip joint with less native bone, resulting in a far less stable joint. FAI arises from abnormalities or defects in the bony structure of the hip, typically taking the form of either asphericity of the femoral head or bony overgrowth of the acetabulum itself. While a surgical intervention to remove the bony overgrowth addresses the painful impingement between the two joint components (femoral head and acetabulum), it does not repair the chondral defect caused by the bony malformation, which, over time, will progress and eventually lead to the need for THA. Mosaicplasty or microfracture have been used in an effort to stimulate the re-growth of damaged cartilage, but these procedures have not proven successful. Similarly, biological interventions utilizing stem cells or platelet rich plasma preparations have not proven to have reliable clinical utility. It is clear that there is an unmet need for an intervention that addresses the challenge of repairing damaged cartilage in patients with FAI. In response to this need, Cytex has developed a therapeutic biphasic device consisting of a high- performance 3D woven textile (cartilage phase) thermally bonded to an 3D printed scaffold (bone phase). This implant immediately performs the functions of the replaced osteochondral tissues and provides a conducive environment for native tissue integration and regeneration, demonstrated through multiple prior and ongoing in vitro and in vivo studies. The goals of this application are as follows: (1) finalize all of the manufacturing (cGMP) processes for the device, (2) file an investigational Device Exemption (IDE) with FDA to enable a clinical study, and (3) conduct a single site feasibility (safety) study enrolling up to 15 patients diagnosed with FAI. The patients to be enrolled will be qualified as surgical candidates for treatment of their FAI and must meet a stringent set of inclusion/exclusion criteria in order to ensure participation in the study at the lowest possible risk, while maximizing the possibility of a successful outcome. We have engaged several partners in this application in order to maximize the possibility of a successful outcome. Our partners include both regulatory and clinical development expertise in orthopaedic device trials and a Clinical Advisory Board of experts in the diagnosis and management of hip preservation surgeries to treat FAI. We expect that positive outcomes will move this technology closer to clinical practice by enabling a pivotal trial, but, also, positive results will establish the role of our implants for other disease states requiring joint restoration surgery.


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: 2025 ( Subtotal = $0 )
2025	2023	CYTEX THERAPEUTICS INC	2609 N DUKE ST STE 303A	DURHAM	NC	27704	DURHAM	USA	Aging Research	001	5	5/30/2025	NON-COMPETING CONTINUATION	$0
2025	2023	CYTEX THERAPEUTICS INC	2609 N DUKE ST STE 303A	DURHAM	NC	27704	DURHAM	USA	Aging Research	000	5	4/10/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	CYTEX THERAPEUTICS INC	2609 N DUKE ST STE 303A	DURHAM	NC	27704	DURHAM	USA	Aging Research	000	5	5/8/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $578,372 )
2023	2023	CYTEX THERAPEUTICS, INC.	2609 N DUKE ST STE 303A	DURHAM	NC	27704	DURHAM	USA	Aging Research	001	5	6/12/2023	NON-COMPETING CONTINUATION	$578,372
2023	2021	CYTEX THERAPEUTICS, INC.	2609 N DUKE ST STE 303A	DURHAM	NC	27704	DURHAM	USA	Aging Research	000	4	6/9/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $578,372

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	CYTEX THERAPEUTICS, INC.	2609 N DUKE ST STE 303A	DURHAM	NC	27704	DURHAM	USA	Aging Research	000	4	4/21/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $1,283,733 )
2021	2021	CYTEX THERAPEUTICS, INC.	2609 N DUKE ST STE 303A	DURHAM	NC	27704	DURHAM	USA	Aging Research	001	4	6/3/2021	NON-COMPETING CONTINUATION	$1,283,733
2021	2018	CYTEX THERAPEUTICS, INC.	2609 N DUKE ST STE 303A	DURHAM	NC	27704	DURHAM	USA	Aging Research	000	2	4/19/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,283,733

Issue Date FY: 2020 ( Subtotal = $1,498,253 )
2020	2020	CYTEX THERAPEUTICS, INC.	2609 N DUKE ST STE 303A	DURHAM	NC	27704	DURHAM	USA	Aging Research	002	3	9/18/2020	COMPETING CONTINUATION	$1,498,253
2020	2018	CYTEX THERAPEUTICS, INC.	2609 N DUKE ST STE 303A	DURHAM	NC	27704	DURHAM	USA	Aging Research	001	2	9/18/2020	NON-COMPETING CONTINUATION	$0
2020	2018	CYTEX THERAPEUTICS, INC.	2609 N DUKE ST STE 303A	DURHAM	NC	27704	DURHAM	USA	Aging Research	000	2	4/28/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,498,253

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2018	CYTEX THERAPEUTICS, INC.	2609 N DUKE ST STE 303A	DURHAM	NC	27704	DURHAM	USA	Aging Research	000	2	12/3/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $708,622 )
2018	2018	CYTEX THERAPEUTICS, INC.	2609 N DUKE ST STE 303A	DURHAM	NC	27704	DURHAM	USA	Aging Research	000	2	5/21/2018	NON-COMPETING CONTINUATION	$708,622
														Subtotal = $708,622

Issue Date FY: 2017 ( Subtotal = $704,742 )
2017	2017	CYTEX THERAPEUTICS INC	2608 ERWIN RD, STE 19A	DURHAM	NC	27705	DURHAM	USA	Aging Research	000	1	9/13/2017	NEW	$704,742
														Subtotal = $704,742

Grand Total All Awards = $4,773,722

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Cartilage Regeneration with Tunable Inflammation Resistance

Award Number: R44AG059310

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/15/2017

PERIOD OF PERFORMANCE END DATE: 05/31/2026

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer