[Asia Economy Reporter Lee Chun-hee] Cha Biotech announced on the 25th that it has successfully completed the administration of the clinical Phase 2a trial for 'CordSTEM®-DD,' a cell therapy for chronic low back pain caused by degenerative lumbar intervertebral disc disease using umbilical cord-derived mesenchymal stem cells.
Starting with the first patient administration in April last year, Cha Biotech administered CordSTEM-DD to a total of 30 subjects. They plan to monitor the subjects for one year to confirm efficacy. Through this, they aim to announce the key results (topline data) of the Phase 2a trial in the first half of next year and subsequently submit an Investigational New Drug (IND) application for the Phase 2b clinical trial to the Ministry of Food and Drug Safety.
CordSTEM-DD is a cell therapy expected to fundamentally treat chronic low back pain by reducing inflammation and regenerating intervertebral discs. Without genetic modification of the stem cells, the therapy uses a cell line that highly expresses the growth factor (TGF-β) which promotes chondrogenic differentiation, enhancing the drug's safety and efficacy.
By utilizing Cha Biotech's proprietary mass culture and freezing technologies, the shelf life of the cells has been significantly extended. This overcomes the disadvantages of non-frozen products such as high production costs due to small-scale manufacturing and short shelf life, thereby increasing commercialization potential. The product, stored frozen, can be thawed and administered to patients immediately upon prescription, which is expected to reduce inconvenience for both patients and medical staff.
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