NeoCart, our Phase 3 investigational product utilizes many aspects of our regenerative medicine platform to repair knee cartilage damage. A NeoCart implant is produced using a patient’s own cartilage cells harvested from the non-weight-bearing cartilage surface of the patient’s femur. The cells are expanded, embedded in our proprietary type I collagen scaffold and then incubated in our proprietary Tissue Engineering Processor (TEP), which is designed to simulate the variation in mechanical forces and low oxygen tension of the knee joint. We believe incubation in this environment helps to ensure that the chondrocyte phenotype is maintained and the cells are producing extracellular matrix proteins crucial to cartilage function prior to implantation. Once biomarkers indicate early signs of chondrocyte function, the neocartilage construct is shipped to the surgical facility and implanted into the patient’s knee defect using our CT3 bioadhesive.
A Phase 1 clinical trial conducted in the United States demonstrated favorable preliminary results, which supported proceeding to a Phase 2 clinical trial. The two-year results of our Phase 1 clinical trial are publicly available. Crawford et al. Am J Sports Med. 2009;37:1334-1343.
A Phase 2 clinical trial conducted in the United States comparing NeoCart to the standard-of-care microfracture met its endpoints for safety and for improvement in pain and function. These results support the continued clinical development of NeoCart. The two-year results of our Phase 2 clinical trial are publicly available. Crawford et al. J Bone Joint Surg Am. 2012;94:979-89.
A Phase 3 clinical trial conducted in the United States comparing NeoCart to the standard-of-care microfracture is currently in progress. Information about the study is available on clinicaltrials.gov.
The investigational NeoCart treatment has three phases.
- Cell collection – The process begins during a short, simple arthroscopic examination when an orthopedic surgeon takes a cartilage biopsy from a non-weight bearing area of the joint. The tissue biopsy is sent to the Histogenics manufacturing facility for culturing into the implant.
- Tissue production – The cartilage cells, or chondrocytes, are isolated from the cartilage and multiplied using standard tissue culture techniques. The cells are harvested, seeded into a unique 3-dimensional collagen scaffold, and cultured under exacting conditions of high pressure, oxygen concentration and perfusion.
- Implant – After a few weeks, a discrete three-dimensional piece of the patient’s own neocartilage, potentially having characteristics of maturing native articular cartilage, is sent to the physician and implanted into the defect in a simple procedure that usually takes less than an hour. We believe within months, there is potential for the matrix to remodel, for the cells to mature, and for the cartilage to integrate with the host tissue.
Caution: New Biologic. NeoCart is limited by federal law to investigational use only and is not available for sale
NeoCart is a registered trademark of Histogenics