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Chondrofluid for arthroscopic knee cartilage repair

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AR081741-01A1
Agency Tracking Number: R41AR081741
Amount: $252,127.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAMS
Solicitation Number: PA22-178
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-09-21
Award End Date (Contract End Date): 2024-08-31
Small Business Information
Irvine, CA 92617-4069
United States
DUNS: 117001436
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (714) 456-1699
Business Contact
Phone: (530) 771-7217
Research Institution
IRVINE, CA 92697-0001
United States

 Nonprofit College or University

Minor injuries to articular cartilage can initiate a catabolic cascade, causing small defects to progress into larger,
more symptomatic defects. Pain, lesion progression, and accelerated joint deterioration may be avoided with
strategies that repair small defects with hyaline-like cartilage. The repair of chondral defects using arthroscopic
techniques, performed in a minimally invasive manner, has advantages over traditional open approaches due to
enhanced access and visualization in the joint, lower risk of infection, and quicker recovery. For the hip and
ankle, arthroscopic cartilage repair is particularly attractive because these joints are difficult to access with open
approaches. To address the need for an effective arthroscopic cartilage repair treatment, Cartilage Inc. has
developed Chondrofluid™, an injectable, biologically active, off-the-shelf cartilage repair product that can be
easily applied arthroscopically to any chondral defect on the femoral and tibial surfaces. Chondrofluid™ is
derived from active, juvenile, allogeneic, costal (rib) chondrocytes using Cartilage Inc.’s patent-pending platform
technologies. At 4ºC, Chondrofluid’s™ liquid form allows it to flow into every crevice of cartilage defects.
Arthroscopic delivery into the body raises Chondrofluid™ past the critical micellization temperature of its
components, causing the self-assembly of cubic lyotropic liquid crystal structures that turn Chondrofluid™ into a
gel, allowing it to attach and lock itself into defects. Ex vivo application of Chondrofluid™ to partial-thickness
defects showed excellent repair tissue fill that integrated into the native cartilage. In vivo, preliminary data show
that Chondrofluid™ fills gouge defects with neocartilage and integrates tissue engineered implants to native
cartilage when applied using open arthrotomy onto defects on the femoral trochlea. The Chondrofluid™
formulation has been modified for arthroscopic approaches, and, toward the regulatory approval of
Chondrofluid™ for arthroscopic use, in vivo validation is needed. Using a preclinical minipig model, this proposal
investigates the arthroscopic treatment of two types of clinically relevant chondral lesions in the knee using
Chondrofluid-MP (minipig cellular product analogous to Chondrofluid). First, a partial thickness, linear, gouge
defect of the medial femoral condyle will be arthroscopically created and treated with injectable Chondrofluid-
MP, or microfracture (positive control), or left empty (negative control) arthroscopically. Second, full-thickness,
small (8x4 mm, which is equivalent to a critical size 1 cm2 defect in the human knee) tibial defects will be
arthroscopically created on the medial tibial plateau and treated with Chondrofluid-MP, or microfracture (positive
control), or left empty (negative control) arthroscopically.

* Information listed above is at the time of submission. *

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