Tego Science said Friday that it has received approval to go ahead with the phase 3 clinical trials for TPX-114, a rotator-cuff tear rejuvenation cell therapy, from the Ministry of Food and Drug Safety (MFDS).
Rotator cuff tear is a tendon rupture that happens due to excessive use of muscles or tendons in the shoulder area and stimulation or strong external impact. Such fractures can cause musculoskeletal, cartilage and bone diseases. However, there is no valid treatment to help regenerate and recover the tendon itself, except performing a physical connection.
TPX-114 is a treatment that injects the patient's fibroblasts into the ruptured tendons, which, in turn, induces the expression of the components of the tendon tissues and its growth factors. Ultimately, the treatment helps repair the injured tendon tissues.
If approved, the drug will become the first cell-based therapeutic agent for tendon regeneration.
The company will conduct phase 3 clinical trials at the Seoul National University Hospital and Seoul National University Bundang Hospital.
“Patients themselves are interested in the clinical trials as the number of patients with rotator cuff tear has been increasing in Korea due to aging and sports leisure activities,” a company official said. “We will accelerate the development of pipelines such as cornea and oral mucosa with the approval of the clinical trials for TPX-114.”