Stem Cell Therapy "Catisstem" Introduces a New Paradigm in Cartilage Regeneration Treatment

Catisstem, Medipost's allogeneic umbilical cord blood-derived mesenchymal stem cell therapy, has introduced a new paradigm in cartilage regeneration treatment.

Catisstem. Medipost

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Medipost announced on October 28 that at the 69th Korean Orthopaedic Association International Congress held from October 16 to 18, Jin Goo Kim, Director of Myongji Hospital, served as the session chair, while Mansoo Kim, Professor at Seoul St. Mary's Hospital of Catholic University, and Dong Won Lee, Professor of Orthopedic Surgery at Konkuk University Hospital, participated as speakers to discuss the clinical value of Catisstem and optimized surgical strategies.

Professor Mansoo Kim, in his lecture on "Latest Clinical Evidence and Clinical Experience," presented the clinical outcomes of Catisstem accumulated over approximately 13 years since its approval as a prescription drug by the Ministry of Food and Drug Safety in 2012. Medipost's Catisstem is an allogeneic stem cell therapy produced by isolating and culturing human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs). At the time of its approval in 2012, results from domestic Phase 3 clinical trials showed an ICRS grade improvement rate of 98%, which was statistically significantly superior to the 71% improvement rate of microfracture surgery, leading to its approval as a prescription drug.

Professor Kim stated, "Catisstem demonstrates much higher proliferation potential and angiogenic capacity compared to MSCs derived from other tissues such as bone marrow, and it also poses a lower risk to donors." He added, "Long-term follow-up studies at five and seven years have consistently shown excellent clinical outcomes." He reviewed recent publications among approximately 30 papers that have confirmed the clinical safety and efficacy of Catisstem over the past 13 years. In particular, he highlighted the two-year follow-up results of a Phase 1/2a clinical trial conducted in the United States, which demonstrated stable safety and efficacy, emphasizing that this treatment is internationally validated. He further evaluated Catisstem as an effective stem cell therapy for cartilage regeneration, possessing higher proliferation capacity and safety compared to MSCs derived from other tissues such as bone marrow.

Professor Dong Won Lee, in his lecture on "Subchondral Bone Pathology and Surgical Know-How," emphasized the importance of the subchondral bone, introducing the new concept that "cartilage and subchondral bone should be treated as a single functional unit." Professor Lee explained, "Subchondral bone has about ten times greater shock absorption capacity than cartilage and acts not merely as a passive victim of arthritis but as a key driver in the onset and progression of the disease." He pointed out that conventional treatments such as microfracture surgery or autologous chondrocyte implantation (ACI) may be effective for short-term symptom relief but have limitations in achieving structural integration and regeneration of both cartilage and subchondral bone. Introducing the latest Catisstem surgical technique, he added, "By forming a deeper bone tunnel than before and sufficiently injecting the stem cell therapy, it is now possible to achieve stable simultaneous regeneration of both cartilage and subchondral bone."

Session chair Jin Goo Kim presented a new perspective on the role of Catisstem, stating, "Over 13 years of clinical experience, the concept has shifted from Catisstem simply differentiating directly into cartilage to the understanding that cartilage regeneration continues for two to three years through subchondral bone remodeling."

A Medipost representative stated, "Through this academic conference, we have confirmed the potential of Catisstem not only for cartilage regeneration but also for contributing to integrated treatment of the entire knee, including the subchondral bone," and added, "We will continue to establish a new standard for the treatment of degenerative arthritis and cartilage regeneration through ongoing research and accumulation of clinical data."

Meanwhile, Catisstem's clinical trials in the United States are currently focusing on preparing for a Phase 3 Investigational New Drug (IND) application, including finalizing the clinical protocol through meetings with the U.S. Food and Drug Administration (FDA). In Japan, the Phase 3 clinical trial is expected to be completed in November with the one-year follow-up of the last patient.

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