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SCM Life Science (SCM Life Science, 298060, CEO Sun Uk Song), a company specializing in research and development of cell therapy, announced on December 30 that it has completed recruiting clinical patients (tested subjects) for phase 2a clinical trials of its acute pancreatitis stem cell therapy.
The clinical trial was conducted on 36 patients with acute pancreatitis above moderate level to confirm the effectiveness and safety of stem cell therapy (SCM-AGH) and 18 patients with placebo control.
The company started recruiting clinical patients through 9 university hospitals, including the Department of Gastroenterology at Soonchunhyang University Bucheon Hospital, targeting patients with moderate to severe acute pancreatitis with organ failure or with a CTSI of 4 or higher. In just 21 months from the start, we successfully completed the registration of 36 test subjects, the total number of recruits.
As this clinical trial begins in earnest, when all patient visits (medication?) are completed by March, a comprehensive analysis of the efficacy and safety of the clinical drug SCM-AGH will be completed, and the final report will be completed around August of this year. In particular, the company plans to focus on confirming the effectiveness of the clinical drug by observing the change in Modified Marshall Score (evaluation score to measure the degree of organ failure of acute pancreatitis) compared to the baseline at the time of SCM-AGH administration on the 28th.
Acute pancreatitis is a fatal disease with a mortality rate of 15% of patients with outbreaks, but there is still no fundamental treatment, so demand for medical unmet is high. SCM Life Science was previously designated as a rare drug in the development stage for the acute pancreatitis stem cell treatment in 2020, and based on the results of phase 2a, it aims to prove its validity and obtain conditional item approval.
SCM Life Science CEO Sun Uk Song said, “Following the completion of the registration of patients with acute pancreatitis phase 2a clinical trial, the ongoing registration of patients with moderate-severe atopic dermatitis phase 2 clinical trial is expected to be completed within this month.” "In addition, two of the three pipelines currently under clinical trials, including the treatment of GVHD, will be able to announce clinical results within this year," he said.