Cha Biotech Announces Clinical Results of Cell Therapy for Low Back Pain: "Safety and Tolerability Confirmed"

'CodeStem-DD' Phase 1·2a Final Results Report
"Thorough Preparation for Next Clinical Trial"

Cha Biotech announced on the 26th that it has received the final Clinical Study Report (CSR) for the Phase 1/2a clinical trial of 'CordSTEM-DD,' a cell therapy for chronic low back pain caused by degenerative lumbar intervertebral disc disease using umbilical cord-derived mesenchymal stem cells.

ChabioTech CI. [Image provided by ChabioTech]

From October 2020 to April 2022, Cha Biotech conducted the Phase 1/2a clinical trial involving 36 patients suffering from pain due to degenerative lumbar intervertebral disc disease to confirm the safety and tolerability of CordSTEM-DD and to collect data for efficacy evaluation.

According to the report, no dose-limiting toxicity (DLT) was observed in the primary endpoint safety assessment, and no Grade 4 or 5 serious adverse drug reactions related to the investigational drug were reported. Accordingly, Cha Biotech explained that safety and tolerability were confirmed.

CordSTEM-DD is a cell therapy expected to fundamentally treat chronic low back pain by reducing inflammation and regenerating degenerated intervertebral discs. Without genetic modification of the stem cells, a cell line overexpressing the growth factor (TGF-β) that promotes chondrogenic differentiation was used to enhance the drug’s safety and efficacy.

Additionally, in September 2021, it was selected as a research project under the government’s Pan-Ministerial Regenerative Medicine Technology Development Program. Cha Biotech explained that if CordSTEM-DD is commercialized, it is expected to provide a new treatment option for patients with chronic low back pain caused by degenerative lumbar intervertebral disc disease who have failed conservative treatments such as existing analgesics and non-surgical therapies.

Hyun-Jung Lee, CEO of Cha Biotech, stated, "We plan to utilize the results obtained from this clinical trial in planning the next clinical trials," adding, "We will thoroughly prepare at each stage to successfully achieve commercialization development."