Bone-on-bone knee pain from osteoarthritis can be agonizing and often results in surgery. But for some patients, there is another therapy option gaining ground – engineered cartilage implants.
Bone-on-bone knee pain from osteoarthritis can be agonizing and often results in surgery. But for some patients, there is another therapy option gaining ground – engineered cartilage implants.
But much like the use of engineering an individual’s own cells to develop an immunotherapy treatment, engineered cartilage is also something that companies have developed as a treatment option for patients. One company that has been approved for such a product is Cambridge, Mass.-based Vericel Corporation. Vericel’s MACI (autologous cultured chondrocytes on porcine collagen membrane) was approved by the U.S. Food and Drug Administration (FDA) in 2016 for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. MACi is the first FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee, according to the company’s data. And it seems that the Vericel procedure is becoming more popular.
Prior to MACI, Vericel had sold Carticel (autologous cultured chondrocytes), a first-generation autologous cellular implant in the United States. It was replaced at the end of the second quarter of 2017 by MACI.
In an interview with Bloomberg, Vericel Chief Executive Officer Nick Colangelo said the number of surgeons trained in the MACI procedure have doubled in the past year. By the end of 2018, there will be about 900 surgeons trained in the procedure, Colangelo told Bloomberg.
According to the Arthritis Foundation, arthritis is the leading cause of disability among adults in the U.S. Worldwide, more than 53 million suffer from arthritis, and is projected to grow to more than 78 million by 2040.
That growth in the number of surgeons becoming trained in the MACI procedure has certainly benefitted the company’s bottom line. Vericel recently released its financial report for the second quarter of the year, which showed a $2 million growth over the same time the previous year. The revenue increase isn’t the only sign of MACI’s growing acceptance. During the quarter, Vericel expanded its MACI sales team from 28 to 40 representatives. Vericel also completed an expansion of MACI manufacturing capacity to support expected growth in MACI demand during the quarter. Additionally, Vericel implemented an expanded pharmacy distribution network to continue expansion of MACI payer access.
In a statement, Colangelo said key performance indicators “point to continued robust growth for MACI” in the second half of 2018.
In addition to MACI, Vericel also markets Epicel (cultured epidermal autografts), a permanent skin replacement indicated for use in adult and pediatric patients received significant skin damage from burns.
Vericel isn’t the only company that has focused on the development of engineered cartilage. Waltham, Mass.-based Histogenics is closing on the potential regulatory approval of its NeoCart replacement cartilage technology. NeoCart is a cartilage-like, tissue engineered implant created from a patient’s own cartilage cells. The company anticipates top-line phase III results from its clinical trial in the third quarter of this year. The trial is designed to show superiority of NeoCart at one year after treatment as compared to microfracture, the current standard of care.
Earlier this summer, Boston-based Orig3n announced its intentions to focus its Cartilage Regeneration Program on osteoarthritis. Orig3n’s cartilage regeneration program is a cell-therapy program that uses induced pluripotent stem cells (iPSCs) from Orig3n’s cell bank. The company’s researchers are working with specialized cells which can be transformed into cell types that work best for cartilage regeneration, the company said. Orig3n’s cell bank is 90 percent Human Leukocyte Antigens (HLA) matched to the U.S. population to ensure compatibility to an individual’s body upon treatment to minimize risk of rejection.
While some companies are developing regenerative therapies as a potential long-term treatment for osteoarthritis of the knee, other pharma companies continue to develop more conventional treatments. Last month, Regeneron and Teva posted positive Phase III results for fasinumab as a treatment for osteoarthritis (OA) of the knee or hip. At 16 weeks patients experienced significantly less pain and also showed significantly improved functional ability from baseline.
