Cole Tests Novel Stem Cell Therapy for Cartilage Repair

The country’s first clinical trial of the stem cell drug, Cartistem, designed to repair knee cartilage damaged by aging, trauma or degenerative diseases, is underway at the Rush University Medical Center. According to the university’s press release, Cartistem is made from mesenchymal stem cells derived from umbilical cord blood that has been supplied by donors. Umbilical cord blood is a readily accessible source of high-quality stem cells, has minimal health risks and carries relatively few ethical concerns. The cells are mixed with hyaluronan, a natural polymer that plays a major role in wound healing and is a building block of joint cartilage.

Brian Cole, M.D. a professor in the department of orthopedics and anatomy and cell biology at Rush University Medical Center is the principal investigator. Cole is also head of Rush’s Cartilage Restoration Center. He and his associates have taken on a major challenge in orthopedics as cartilage damage has long resisted attempts to repair it. The tissue lacks blood vessels and nerves and so has little capacity to regenerate itself.

“Finding a biological solution for cartilage regeneration in orthopedics is one of the fastest growing areas of research and development in our specialty, ” said Cole. “Rush is spearheading this field of research with the ultimate goal of safely improving outcomes and sparing patients from having more complicated surgery at a relatively young age.”

The Phase I and II study is planned to last for two years and will enroll twelve participants age 18 and older with a body mass index of less than 35. The plan is to enroll six participants with cartilage lesions of from two to five centimeters and six more participants who have lesions larger than five centimeters. All 12 will be followed up for a year, to determine the safety and efficacy of the drug, and will be evaluated again at the end of two years.

“With a burgeoning aging, yet active population, our patients are looking for effective non-joint replacement solutions to treat their damaged knee cartilage, ” said Cole. “This research is significant in that it utilizes a commonly performed operation (microfracture) in an effort to improve upon variable outcomes.” He added, “Notably, this is a treatment for patients with localized cartilage damage and not for patients who are diagnosed with diffuse or bone on bone arthritis who have otherwise been told they require a knee replacement.”