NeoCart Tissue Implant Superior to Microfracture (Biloine Young @ OTW)
The regenerative medicine company Histogenics Corporation received encouraging news in an article in the Journal of Bone and Joint Surgery reporting the two-year results of a Phase 2 clinical trial of its product NeoCart Autologous Cartilage Tissue Implant (ACTI). The implant is designed for patients with grade II chondral injury to the femur (the cartilage in the knee).
NeoCart is an autologous bioengineered neocartilage grown outside the body using the patient’s own cells for the repair of full thickness cartilage lesions. The current standard of care for this problem is microfracture surgery which works by creating tiny fractures in the underlying bone. While this treatment is widely recommended as a primary treatment for chondral injury to the femur, outcome measures have been reported to plateau between 12 to 24 months.
The results of the two-year Histogenics study, as reported in the June 6 news release, are that NeoCart has a comparable safety profile to microfracture surgery, significantly improves pain and function within six months of treatment, provides significantly greater improvements in a greater proportion of patients than microfracture, and is associated with greater clinical efficacy two years after treatment than does microfracture.
Dennis Crawford, M.D., Ph.D., Assistant Professor, Orthopedics, Oregon Health Science University and the lead author of the paper, said, “Preliminary findings strongly suggest that autologous cartilage tissue implant using NeoCart significantly improved knee pain and function within six months and provided significantly greater improvements, in a greater proportion of patients, than microfracture. This includes, importantly, greater clinical efficacy two years after treatment in contrast to those treated with microfracture surgery.”
He went on to say, “There is a clinical need for a primary surgical treatment option for cartilage repair that improves on the historical outcomes of microfracture and the results detailed in our recent analysis and publication strongly suggest that NeoCart may meet this need as a first-line therapeutic alternative to microfracture procedures.”
Histogenics officials report that a multi-center randomized Phase 3 study of NeoCart is presently underway comparing that treatment of articular cartilage defects of the knee with microfracture surgery.
Histogenics is a regenerative medicine company that combines cell therapy and tissue engineering technologies to develop innovative products for tissue repair and regeneration. In May 2011, Histogenics acquired the Israeli cell-therapy company Prochon BioTech. Histogenics’ products focus on the treatment of active patients suffering from articular cartilage derived pain and immobility.