Study on Safety and Efficacy of UCB-MNCs for Chronic Radiation Enteritis
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Cancer Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- UCB-MNCs
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov