SCM Life Sciences Announces Phase 2a Clinical Trial Results of Stem Cell Therapy for Pancreatitis

Professor Shin Ilsang of Soonchunhyang University Bucheon Hospital is presenting the results of the Phase 2a clinical trial of SCM-AGH. (Photo by SCM Life Sciences)

[Asia Economy Reporter Chunhee Lee] SCM Life Sciences, a cell therapy research and development (R&D) company, announced on the 2nd that it presented the results of the Phase 2a clinical trial of its acute pancreatitis stem cell therapy ‘SCM-AGH’ at the 6th International Digestive Disease Week Korea (KDDW 2022) held on the 1st.

The presentation was delivered by Professor Il-Sang Shin of Soonchunhyang University Bucheon Hospital, who directly participated in the clinical trial, explaining the main results, achievements, and significance. The presentation abstract was also selected as the best abstract.

The clinical trial of SCM-AGH for acute pancreatitis stem cell therapy involved administering SCM-AGH to four patients with acute pancreatitis accompanied by organ failure in Phase 1 to confirm tolerability. In Phase 2a, the trial was conducted on 36 patients with moderate to severe acute pancreatitis accompanied by organ failure or a Computed Tomography Severity Index (CTSI) of 4 or higher.

Professor Shin presented cases from the trial showing that after SCM-AGH administration in Phase 2a, the Modified Marshall Score, an evaluation score measuring the degree of organ failure, decreased on day 7, and the CTSI tended to decrease on day 28. He also emphasized that C-Reactive Protein (CRP) and Interleukin (IL)-6 significantly decreased at day 3 post-administration.

Professor Shin explained, “Allogeneic bone marrow-derived stem cells can be safely administered to patients with moderate to severe acute pancreatitis and can exhibit early anti-inflammatory effects.”

SCM Life Sciences is preparing for a Phase 2b clinical trial to confirm the efficacy of SCM-AGH and plans to apply for clinical trial approval (IND) from the Ministry of Food and Drug Safety next year. Having previously received orphan drug designation for SCM-AGH during the development stage, the company’s strategy is to obtain conditional marketing authorization upon successful completion of Phase 2b and proceed with early commercialization.