Study on Safety and Efficacy of UCB-MNCs for Chronic Radiation Enteritis

Официальное название

Study on the Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in the Treatment of Chronic Radiation Enteritis

Обзор

This study aims to evaluate the safety and efficacy of the umbilical cord blood mononuclear cells (UCB-MNCs) therapy for chronic radiation enteritis (CRE) by observing factors related to the therapeutic effect and adverse reactions of UCB-MNCs in treating CRE.

Вмешательства

• Биопрепарат UCB-MNCs
  UCB-MNCs will be administered via intravenous infusion three times, once per week, with a dose of 3×10⁸ cells per infusion.

Первичные конечные точки

• Change from baseline Vienna Rectoscopy Score (VRS) [Срок оценки: At 3 and 12 months after the last treatment.]

Вторичные конечные точки (5)

• Clinical remission rate [Срок оценки: At 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment.]
• Change from baseline LENT-SOMA scoring scale [Срок оценки: At 3 months and 12 months after the last treatment.]
• Change from baseline visual analog scale (VAS) [Срок оценки: At 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment.]
• Hemoglobin concentration [Срок оценки: Changes in hemoglobin levels will be compared before treatment and at 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment.]
• Changes in Intestinal Flora Distribution [Срок оценки: At 1 week and 1 month after the last treatment.]

Критерии участия

Критерии включения

• Aged 18-75 years, with no restriction on gender;
• History of pelvic and abdominal radiotherapy;
• Patients diagnosed with chronic radiation-induced intestinal injury (CRII) via colonoscopy and pathological examination (≥3 months after the end of radiotherapy);
• Diagnosed with grade 2-3 radiation-induced intestinal injury based on the clinical symptom assessment (RTOG classification) in Expert Consensus on Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Radiation-Induced Intestinal Injury in China;
• Poor response to conventional treatment for two weeks, with symptoms showing no remission or progressive aggravation;
• Well-controlled tumor for ≥3 months;
• No significant abnormalities in liver and renal function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN); serum creatinine (Cr) and blood urea nitrogen (BUN) ≤ 2 times the upper limit of normal (ULN);
• Expected lifespan of the subject ≥ 3 months;
• The patient is informed of the study details and voluntarily signs the informed consent form;
• Willing and able to receive treatment and complete follow-up in accordance with the protocol requirements, and able to adhere to the doctor's advice for basic treatment.

Критерии исключения

• Severe cardiac insufficiency (e.g., NYHA classification Grade Ⅲ or Ⅳ) and uncontrolled hypertension with medication (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 110 mmHg);
• Positive results for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis;
• Eastern Cooperative Oncology Group (ECOG) performance status score ≥ 2;
• Currently participating in another clinical trial or having participated in another clinical trial within 4 weeks;
• Patients with an allergic diathesis or known allergy to the preparation used in this trial;
• Patients with comorbid mental illness who are unable to cooperate with treatment;
• Pregnant or lactating women.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhejiang Cancer Hospital — Ханчжоу

Идентификаторы

NCT: NCT07175207 · 2025&UCB-MNCs&CRE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗