Results from a national project proving the therapeutic effects of ‘RegenSeal’ by Cellontech, a subsidiary of SCN Engineering, have been selected as a presentation topic at an international conference.
Cellontech, a regenerative medicine-focused bio company, announced on the 11th that clinical research verifying the efficacy and safety of RegenSeal for patients with rotator cuff (shoulder tendon) tears was presented at the ‘International Congress on Shoulder and Elbow Surgery (ICSES)’ held in Rome, Italy, from the 5th to the 8th. ICSES is the world’s largest specialized academic conference in the field of shoulder and elbow joints, held every three years.
In 2020, Cellontech was selected as a participating research institution for the national project ‘Medical Device Commercialization Capability Enhancement Project’ under the ‘Pan-Ministerial Full-Cycle Medical Device R&D Project’ and conducted joint clinical research to confirm the therapeutic effects of RegenSeal, which is currently marketed domestically. RegenSeal is a collagen-based tissue supplement developed independently by Cellontech, using bio-collagen to graft and replenish soft tissues such as ligaments and tendons that are defective or damaged.
Professors Song Hyun-seok and Kim Hyung-seok from the Department of Orthopedics at Eunpyeong St. Mary’s Hospital, Catholic University, who led the clinical study, conducted research on 55 patients who underwent arthroscopic rotator cuff repair surgery due to rotator cuff tears.
The study randomly assigned 29 patients to the experimental group, which received matrix-type RegenSeal combined with conventional repair surgery, and 26 patients to the control group, which underwent repair surgery alone. Clinical assessments such as the Visual Analog Scale (VAS) for pain, the American Shoulder and Elbow Surgeons (ASES) score for shoulder function, and Range of Motion (ROM), along with imaging tests including Magnetic Resonance Imaging (MRI), were used for in-depth comparative analysis. The results showed a retear rate of only 10.3% in the experimental group, whereas the control group had a retear rate of 34.6%, approximately three times higher. No side effects related to RegenSeal were observed.
Professor Song stated at the conference, “When RegenSeal was used in combination, it showed a statistically significant higher tendon healing rate and lower retear rate compared to the control group,” adding, “We confirmed that RegenSeal, using bio-collagen, is an effective treatment option for reconstructing torn rotator cuffs.”
A Cellontech representative said, “Rotator cuff tears are the most common cause of chronic shoulder joint pain, and the number of patients is rapidly increasing due to aging. Especially in cases with large tear sizes or elderly patients with concerns about tendon regenerative capacity, where repair surgery failure and retear risk are high, RegenSeal made from bio-collagen with excellent tissue adhesion and regenerative ability can enhance therapeutic effects.”
They added, “The clinical research results of RegenSeal will also be presented at the upcoming international academic conference of the Korean Orthopaedic Association to be held in Korea this October.”
Meanwhile, Cellontech is also striving to enter overseas markets with medical devices for human tissue regeneration using bio-collagen. Earlier this month, Cellontech announced an exclusive sales supply contract with Beijing Meiyan Space Technology, a subsidiary of Sichuan Pharmaceutical, for the collagen filler ‘TheraFill,’ targeting the Chinese medical aesthetics market, which is estimated to be worth 55.5 billion yuan (approximately 10 trillion KRW) in 2022.
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