A Clinical Trial to Evaluate the Safety and Efficacy of for Ulcerative Colitis.

AIMS

We previously reported that telomerase activator (CA) can normalize the crypt structure of human colonic organoids in an ulcerative colitis (UC) model. Therefore, we aimed to evaluate the safety and efficacy of CA for UC in a clinical trial.

METHODS AND RESULTS

Ten patients with mild UC were recruited. Patients received 500 mg of oral CA extract tablets once daily for 12 weeks. Safety and efficacy were monitored based on clinical manifestations, biomarkers, endoscopic findings, histopathological findings, and telomere length. Among 10 patients, one patient withdrew due to the relapse of UC. No adverse events were identified during the medication in the remaining nine patients. One patient showed a Partial Mayo Score (pMayo) decrease from 1 to 0, while the remaining eight pMayo scores remained at 0 before and after treatment. CRP, ESR, and leucine-rich alpha 2 glycoprotein (LRG) levels remained unchanged throughout treatment. Two patients showed endoscopic improvement. The other two patients showed histological improvement. Among five patients, relative telomere length of the rectum remained unchanged by treatment.

CONCLUSION

CA is safe for patients with UC. Longer treatment durations and larger participant pools are required to assess CA efficacy on histological healing in the future.