One Stage Regeneration System For Articular Cartilage Repair From Depuy Mitek Shows Promise In Pilot Study

Main Category: Bones / Orthopaedics
Also Included In: Sports Medicine / Fitness
Article Date: 01 May 2007 - 2:00 PDT

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DePuy Mitek, Inc. announced a critical milestone in its multi-center randomized pilot study evaluating the safety and performance of its Cartilage Autograft Implantation System (CAIS), with 29 patients enrolled in the study in the United States since March 2006.

This investigational device and method is designed as a primary surgical treatment of damaged knee cartilage using the patient's own healthy cartilage in a single operation. This study, comparing CAIS to microfracture in patients with lesions of the articular knee cartilage, is the first prospective, randomized multi-center clinical trial for a cell-based therapy product intended for cartilage repair in the United States.

"I am excited about the positive study results for this potential advance in cartilage repair. By combining intraoperative cartilage processing and a unique scaffold, this procedure could eliminate the need for a second operation and the expense of cell culturing," said Jack Farr, MD a clinical investigator and orthopedic surgeon at OrthoIndy in Indianapolis, where the first patients were implanted. "This comparative investigation highlights the continuing developments in the field of cartilage restoration."

The control group received a microfracture, a common procedure that has been performed for many years for cartilage repair. In the procedure, several tiny holes, or microfractures, are made in the bone beneath the defect causing bone marrow cells and blood to clot and cover the damaged area to promote healing and tissue repair. Published studies indicate that microfracture only produces softer fibrous cartilage and may require a subsequent operation.

"This technique under investigation would eliminate the need for a second procedure as required by other cell-based technologies, and also could eliminate the need for tedious suturing or the use of expensive donor cartilage potentially associated with the small risk of disease transmission" says Brian Cole, head of the Rush Cartilage Restoration Center, Chicago. "The large animal studies performed at Rush showed hyaline-like cartilage is produced with this system and this study is building on that."

CAIS is a joint development effort between DePuy Mitek and Johnson & Johnson Regenerative Therapeutics, LLC, a regenerative medicine research and development organization. In CAIS, healthy cartilage cells are harvested, placed on to a bioabsorbable scaffold and implanted all in the same surgical procedure. DePuy Mitek scientists were the first to recognize and confirm the breakthrough that chondrocytes when processed/treated appropriately can be re-implanted immediately into the patient.

It is widely reported that those who have an untreated traumatic cartilage injury at a younger age are at risk of developing osteoarthritis later in life.

Other surgeons and centers involved in the U.S. pilot were: John Richmond at New England Baptist Hospital in Boston, MA, Bert Mandelbaum at Santa Monica Orthopedics Group in California, Timothy Hosea at St. Peter's University Hospital and CARES Facility in New Brunswick, NJ, and Ralph Gambardella at Kerlan-Jobe Clinic in Los Angeles.

A similar pilot study is currently underway in Europe, designed to enroll approximately 30 subjects at six sites: Prof. Fredrik Almqvist, University of Gent in Belgium; Prof. Stefan Nehrer, Danube University, Krems, Austria; Dr. Mats Brittberg, Kungsbacka Hospital, Sweden; Tim Spalding, University of Warwick, Coventry, United Kingdom; Prof. Andreas Imhoff, Technische Universität, München Germany; Dr.Claudio Zorzi, Ospedale S. Cuore, Verona.

Information from both the U.S. and European pilot studies will be collected upon which to base the design of a larger, pivotal study in the U.S. Commercialization of the Cartilage Autograft Implantation System in Europe is planned in 2008.

About DePuy Mitek, Inc.

DePuy Mitek, Inc., a Johnson & Johnson company, is a leader in sports medicine and arthroscopy with a range of solutions that "Restore the Anatomy"™. DePuy Mitek also offers ORTHOVISC® (High Molecular Weight Hyaluronan) visco-supplementation, a non-surgical treatment for mild-moderate osteoarthritis knee pain. For more information, go to http://www.depuymitek.com and http://managingosteoarthritis.com.

ORTHOVISC® is a registered trademark of Anika Therapeutics. Manufactured by Anika Therapeutics. Anika Therapeutics, Inc. Woburn, MA 01801 USA