Cord blood cells aim to heal Radiation-Damaged intestines
NCT ID NCT07175207
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase trial tests whether umbilical cord blood cells can safely help people with chronic radiation enteritis, a painful gut condition caused by cancer radiation therapy. Ten adults who have had pelvic or abdominal radiation will receive three weekly infusions of these cells. Researchers will monitor for side effects and look for signs of healing in the gut lining and symptom relief.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- umbilical cord blood mononuclear cells (UCB-MNCs)
- What this could lead to
- If it works, this could point toward a new treatment to repair intestinal damage from radiation therapy.
- What could go wrong
- This is a very early, small trial with only 10 people. It is designed mainly to check safety, not to prove effectiveness. The treatment may not work or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18-75 years, with no restriction on gender; 2. History of pelvic and abdominal radiotherapy; 3. Patients diagnosed with chronic radiation-induced intestinal injury (CRII) via colonoscopy and pathological examination (≥3 months after the end of radiotherapy); 4. 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; 5. Poor response to conventional treatment for two weeks, with symptoms showing no remission or progressive aggravation; 6. Well-controlled tumor for ≥3 months; 7. 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); 8. Expected lifespan of the subject ≥ 3 months; 9. The patient is informed of the study details and voluntarily signs the informed consent form; 10. 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. Exclusion Criteria: 1. 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); 2. Positive results for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis; 3. Eastern Cooperative Oncology Group (ECOG) performance status score ≥ 2; 4. Currently participating in another clinical trial or having participated in another clinical trial within 4 weeks; 5. Patients with an allergic diathesis or known allergy to the preparation used in this trial; 6. Patients with comorbid mental illness who are unable to cooperate with treatment; 7. Pregnant or lactating women.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China