Chronic Radiation Induced Intestinal InjuryEarly Phase 1NCT07175207
Study on Safety and Efficacy of UCB-MNCs for Chronic Radiation Enteritis
A Early Phase 1 study testing UCB-MNCs in people with Chronic Radiation Induced Intestinal Injury and Chronic Radiation Enteritis, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Radiation Induced Intestinal Injury, Chronic Radiation Enteritis
- What is being tested?
- UCB-MNCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Ji ZHU, MD, 0571-88128212, zhuji@zjcc.org.cn
About this study
Official title: Study on the Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in the Treatment of Chronic Radiation Enteritis
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.
- Being tested
- UCB-MNCs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCB-MNCsBiological
UCB-MNCs will be administered via intravenous infusion three times, once per week, with a dose of 3×10⁸ cells per infusion.
| Study group | Role | What they receive |
|---|---|---|
| UCB-MNCs | Experimental | UCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation Receives: Biological: UCB-MNCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Vienna Rectoscopy Score (VRS)
The VRS evaluates four core endoscopic features (mucosal hyperemia/erythema, mucosal ulceration, mucosal fibrosis/stenosis, and telangiectasia), with each feature scored on a 0-3 scale (0 = no abnormality, 3 = severe abnormality). The total VRS score is the sum of scores from the four features, typically ranging from 0 to 12. The total score directly reflects the severity of radiation-induced intestinal injury.
Measured: At 3 and 12 months after the last treatment.
Secondary outcomes (5)
Clinical remission rate
Symptoms such as hematochezia and diarrhea will be counted before treatment and at 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment. The corresponding symptom remission rate will be calculated by comparing with the pre-treatment status.
Measured: At 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment.
Change from baseline LENT-SOMA scoring scale
LENT-SOMA uses a 0-4 grading system for each of the four dimensions (subjective, objective, management, analytic), with scores directly reflecting the severity of radiation-induced tissue injury. A higher LENT-SOMA grade indicates more severe radiation-induced tissue damage.
Measured: At 3 months and 12 months after the last treatment.
Change from baseline visual analog scale (VAS)
VAS is a simple tool to measure pain extent: it uses a 10-centimeter horizontal line, with "no pain at all" marked at 0 and "worst pain imaginable" at 10. Patients mark a point matching their current pain.
Measured: At 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment.
Hemoglobin concentration
Measured: 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
Intestinal flora distribution specifically describes the composition, quantity, and proportional balance of the microbial species.
Measured: At 1 week and 1 month after the last treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Radiation Induced Intestinal InjuryStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Zhu, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175207
- Sponsor's protocol ID
- 2025&UCB-MNCs&CRE
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in the Treatment of Chronic Radiation Enteritis
- ClinicalTrials.gov ID
- NCT07175207
- Acronym / sponsor ID
- 2025&UCB-MNCs&CRE
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UCB-MNCs | Experimental | Biological: UCB-MNCsUCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UCB-MNCsUCB-MNCs will be administered via intravenous infusion three times, once per week, with a dose of 3×10⁸ cells per infusion. | Biological | UCB-MNCs |
Primary outcome
Change from baseline Vienna Rectoscopy Score (VRS)
Time frame: At 3 and 12 months after the last treatment.
The VRS evaluates four core endoscopic features (mucosal hyperemia/erythema, mucosal ulceration, mucosal fibrosis/stenosis, and telangiectasia), with each feature scored on a 0-3 scale (0 = no abnormality, 3 = severe abnormality). The total VRS score is the sum of scores from the four features, typically ranging from 0 to 12. The total score directly reflects the severity of radiation-induced intestinal injury.
5 secondary outcomes
Clinical remission rate
Time frame: At 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment.
Change from baseline LENT-SOMA scoring scale
Time frame: At 3 months and 12 months after the last treatment.
Change from baseline visual analog scale (VAS)
Time frame: At 1 week, 1 month, 3 months, 6 months, and 12 months after the last treatment.
Hemoglobin concentration
Time frame: 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
Time frame: At 1 week and 1 month after the last treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing UCB-MNCs in people with Chronic Radiation Induced Intestinal Injury and Chronic Radiation Enteritis, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ji ZHU (0571-88128212, zhuji@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Vienna Rectoscopy Score (VRS) (time frame: At 3 and 12 months after the last treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.