Repairing Knee Cartilage Defects with the Patient’s Own Cells

Autologous cell therapy (ACT) uses patient cells cultured and expanded outside the body and reintroduces them to the donor for a variety of treatments. This form of therapy has been employed successfully to bionengineer skin substitutes, assist in wound healing, counteract chronic inflammation, treat burns and pressure ulcers, and boost post-op healing. This approach is especially useful because using the patient’s own cells minimizes risks from systemic immunological reactions, bio-incompatibility, and disease transmission due to grafts or cells not grown from the patient.
 
Berlin, Germany-based CO.DON has harnessed this therapy for the treatment of articular cartilage defects. The company’s matrix-associated autologous cartilage cell transplantation (M-ACT) procedure involves harvesting the patient’s cells and transplanting them back into the patient’s damaged knee cartilage to promote healing. As a completely autologous therapy, it does not contain animal, synthetic, or allogenic products. The M-ACT procedure is currently well established in Europe, but CO.DON is eyeing clinical development in North America.
 

To get more information about CO.DON, the company’s M-ACT procedure, and how M-ACT can revolutionize the regenerative approach to articular damage treatment, I spoke with Ralf Jakobs, CEO of CO.DON:
 
Sam Brusco: What is CO.DON’s history?
 
Ralf Jakobs: CO.DON, the company I lead as CEO, is focused on the development, production, and marketing of cell-based products for joint-preserving, regenerative treatment of articular cartilage defects. CO.DON has been operating in tissue engineering for more than 25 years, making us a very experienced manufacturer of cell and tissue transplants. Our unique minimally invasive, 100 percent autologous chondrocyte transplantation cell therapy allows for treatment of cartilage damage in the knee joint using a patient’s own cells.
CO.DON’s main product treats knee cartilage defects for adults experiencing pain and mobility problems. This three-dimensional chondrocyte product received central EU marketing authorization from the European Commission, based on the assessment by the European Medicines Agency (EMA). It is now available in Germany, the Netherlands, England, Austria, and Switzerland. We are working on adding additional locations in Europe and have recently finalized our first License Agreement with a strong partner in Russia.
 
Brusco: How does M-ACT work?
 
Jakobs: M-ACT starts with taking a small piece of cartilage from the patient’s knee using arthroscopy. The cartilage cells are then sent to CO.DON, where, over a period of seven weeks, the chondrocytes—the cells in healthy cartilage that give it its structure—are isolated and multiplied in the laboratory. The chondrocytes naturally adhere together to form spheroids or spherical balls. The spheroids are then placed into the damaged area of the patient’s cartilage where they adhere naturally within 20 minutes and then regeneration of the cartilage begins. The new tissue combines with any remaining healthy cartilage, producing a strong repair. Arthroscopic examinations after the M-ACT procedure show good filling of the defect with hyaline-like tissue and seamless integration with the native cartilage.

 
Brusco: What unmet need in orthopedic care does it fill?
 
Jakobs: With the incidence of cartilage defects reported to be as high as 65 percent in routine knee arthroscopies, CO.DON´s M-ACT fills an unmet need for regenerative treatments. It is designed to repair cartilage damage before it worsens or develops into osteoarthritis. The goal of our treatment is to postpone and possibly even avoid the need for prosthesis. Other common treatments include painkillers or even knee replacements. As one of our patients said after our treatment: “I’ve regained a pain-free life in motion!”
 
Brusco: How is M-ACT an improvement on typical treatments for articular damage?
 
Jakobs: CO.DON’s 100 percent autologous cartilage repair treatment epitomizes “personalized medicine.” The treatment is generated from the patient’s own cells, and is free from animal, synthetic, and allogenic products so the risk of rejection is low. It is minimally invasive and the only EU licensed cell-based pharmaceutical product for the regenerative treatment of knee cartilage defects that is also indicated for patients 55 years and older. Usually, cartilage repair treatments are indicated for patients ages 18-55.

 
Brusco: How does CO.DON ensure the quality of collected cell samples?
 
Jakobs: CO.DON’s proprietary Integrated Isolator Technology (IIT) cleanroom is the most sophisticated in the industry. This unique technology ensures that patients’ chondrocytes maintain absolute purity and sterility prior to transplant and eliminates any potential for cross contamination—without the use of antibiotics and fungistatic agents and without genetic modifications. The modular design of the cleanroom production facility is readily expandable and easily transferable to other locations/geographies.
 
Brusco: What success has the M-ACT procedure found so far?
 
Jakobs: CO.DON is proud to report that more than 15,000 procedures have been performed in over 200 clinics using our technology. Our EU single marketing authorization provides a “first mover” competitive advantage—success we feel can be replicated in North America and other geographies. CO.DON’s product is also the only EU licensed cell-based pharmaceutical product for the regenerative treatment of cartilage defects of the knee.

 
Brusco: What’s next for CO.DON’s M-ACT procedure?
 
Jakobs: Currently approved in Europe for adults, CO.DON is working to expand indications to a wider range of patients, including adolescents. Our technology also has a broad potential for new applications across the cartilage repair continuum: i.e., hip, shoulder, ankle, elbow. We are eyeing geographic expansion, including into North America. Also, this October, CO.DON will celebrate a major milestone: The “Grand Opening” of its new Leipzig production site, which will be one of the world’s most unique facilities for the industrial-scale production of autologous human cell transplants.