RecruitingPhase 1/2

Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis

China24 participantsStarted 2024-05-24

Plain-language summary

A Phase I/II study to evaluate the safety and preliminary efficacy of human umbilical cord-derived mesenchymal stem cell injection for the treatment of chronic radiation proctitis.

Who can participate

Age range18 Years – 79 Years

SexALL

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Inclusion criteria

✓. Fully understand and sign the informed consent form;
✓. Age ≥18 years and \<80 years;
✓. Good physical condition (WHO performance status score 0-1);
✓. Pathologically diagnosed with pelvic malignant tumors and received radiotherapy;
✓. Diagnosed with chronic radiation proctitis after at least 6 months of endoscopic examination following the completion of radiotherapy and ineffective conventional treatment;
✓. Screening period LENT-SOMA score ≥1;
✓. Subjects and their spouses or partners have no plans for conception from screening to 6 months after the end of the trial, no plans for sperm or egg donation, and agree to use effective non-pharmacological contraceptive measures during the trial.

Exclusion criteria

✕. Patients with severe liver or kidney dysfunction during the screening period;
✕. Patients with severe congestive heart failure or coronary artery disease during the screening period;
✕. Patients with allergic constitution or severe systemic immune diseases;
✕. Patients with active gastrointestinal bleeding or acute intestinal obstruction during the screening period;
✕. Pregnant patients;
✕. Patients with rectal stenosis or fistula formation requiring surgical treatment that limits endoscopic therapy;
✕. Patients with a screening period LENT-SOMA score of 4;
✕. Patients with tumor recurrence or metastasis;

What they're measuring

The severity of adverse events after administration as assessed by CTCAE v5.0.

Timeframe: 28 days (1 month)

The incidence of adverse events after administration.

Timeframe: 28 days (1 month)

Trial details

NCT IDNCT06438809

SponsorJiangsu Topcel-KH Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05

Contact for this trial

Zhaoshen Li, MD

021-81873241 zhsl@vip.163.com

View on ClinicalTrials.gov More Chronic Radiation Proctitis trials