MEDIPOST announced on the 4th that the cartilage regeneration effect was confirmed in a combination clinical trial applying its stem cell treatment 'CATIS' and high tibial osteotomy (HTO) simultaneously in patients with moderate to severe degenerative knee osteoarthritis.
High tibial osteotomy is a surgery that improves knee joint alignment and slows the progression of arthritis in middle-aged individuals. However, its limitation has been noted due to the restricted long-term cartilage regeneration effect.
The research results led by Professor Kim Seok-jung's orthopedic team at The Catholic University of Korea, Uijeongbu St. Mary’s Hospital, were published in the latest issue of the international journal 'Stem Cell Research & Therapy.'
The research team followed up on 10 patients with degenerative knee osteoarthritis, averaging 58.5 years old (with an average body mass index of 27.8 kg/m²), after transplanting CATIS for at least two years.
As a result of the treatment, the average cartilage lesion size significantly decreased from 7 cm² before surgery to 0.16 cm² after surgery. This indicates a cartilage regeneration rate of 97.7%. Additionally, the grading index defined by the International Cartilage Repair Society (ICRS Grade), which evaluates the degree of cartilage damage, improved significantly. It was assessed at grade 4, the most severe level, before surgery, but recovered to nearly normal at grade 1 after surgery.
The improvement in the patients' quality of life was also notable. The score evaluating physical health status (SF-36 PCS) increased from 27.9 points to 55.3 points, a 98.2% improvement, and the mental health status (SF-36 MCS) score improved from 41 points to 63.1 points, a 53.9% improvement. This indicates a significant enhancement in overall life satisfaction and mental well-being as knee pain decreased.
The company explained, “This study shows that the umbilical cord-derived mesenchymal stem cell transplantation performed simultaneously with high tibial osteotomy promotes cartilage regeneration and is especially effective for middle-aged overweight patients with extensive cartilage defects larger than 4 cm², which is noteworthy.”
The transplanted umbilical cord-derived mesenchymal stem cells can be regarded as 'SUPERCELL,' which exhibits superior biological characteristics such as low immunogenicity, high proliferation, and excellent cartilage differentiation compared to conventional autologous bone marrow-derived or adipose-derived stem cells. Their collection is non-invasive, and they can be supplied in a commercially available ready-made form.
Professor Kim Seok-jung of the orthopedic department at The Catholic University of Korea, Uijeongbu St. Mary’s Hospital noted, “Future studies comparing umbilical cord-derived mesenchymal stem cell transplantation alone versus high tibial osteotomy alone, as well as long-term follow-ups, are needed,” adding that “the introduction of non-invasive cartilage assessment utilizing MRI (Magnetic Resonance Imaging) is also anticipated.”
A representative of MEDIPOST said, “This research result objectively proves that CATIS has a practical cartilage regeneration effect, not just simple symptom relief,” and added, “We plan to continue expanding the treatment area of CATIS through ongoing clinical studies.”
CATIS is the world's first allogeneic umbilical cord-derived stem cell treatment approved in 2012. It has confirmed fundamental therapeutic effects that suppress inflammation caused by degenerative and repetitive traumatic arthritis, as well as regenerate damaged cartilage to its natural state, proving long-term efficacy. As of May this year, the cumulative number of treated patients has exceeded 33,000.
MEDIPOST announced that it is currently preparing for the application for U.S. clinical phase 3 trial approval (IND) through meetings with the U.S. Food and Drug Administration (FDA). The clinical trial in Japan has completed treatment for the last patient in phase 3, and approximately 70% of the subjects have finished one year of follow-up.
References
Stem Cell Research & Therapy (2025), DOI: https://doi.org/10.1186/s13287-025-04356-9