NeoCart, our Phase 3 investigational product utilizes many aspects of our restorative cell therapy platform for orthopedic use. NeoCart combines breakthroughs in bio-engineering and cell processing to enhance the autologous cartilage repair process. The restorative cell therapy merges a patient’s own cells with a fortified three-dimensional scaffold designed to accelerate healing and reduce pain, with patients receiving functional living cartilage at the time of treatment. NeoCart’s ability to function like a cartilage upon implantation with our proprietary bioadhesive may allow earlier weight bearing and return to activities.
A nine patient 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 30 patient 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 249 patient Phase 3 clinical trial conducted in the United States comparing NeoCart to the standard-of-care microfracture was stopped after the trial did not meet its primary endpoint. Information about the study is available on clinicaltrials.gov.
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NeoCart Implant Surgical Procedure
NeoCart, which is currently being investigated in a Phase 3 clinical trial has three phases over approximately six to eight weeks.
- Cell collection – The process begins during a short, simple arthroscopic examination when an orthopedic surgeon takes a cartilage biopsy from a non-weight bearing cartilage surface of the patient’s femur at the time of the initial diagnosis. The tissue biopsy is sent to the Histogenics manufacturing facility for culturing and expansion.
- 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 in our proprietary Tissue Engineering Processor (TEP). This incubation 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.
- 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 using our CT3 bioadhesive in a simple procedure that usually takes less than thirty minutes. 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