Radiation ProctitisPhase 1NCT06925607
Evaluate the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Radiation Proctitis
A Phase 1 study testing Mesenchymal Stem Cells (MSCs) in people with Radiation Proctitis, run by Jiangsu Topcel-KH Pharmaceutical Co., Ltd..
Trial summary
A Phase l clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with Radiation proctitis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radiation Proctitis
- What is being tested?
- Mesenchymal Stem Cells (MSCs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Dec 2026
- Phase
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Good physical condition (WHO performance status score 0-1).
- Patient received radiotherapy after being pathologically diagnosed with pelvic malignant tumors
- Patient diagnosed with chronic radiation proctitis after undergoing colonoscopy more than 6 months after the completion of radiotherapy and did not respond to conventional treatment.
- The LENT-SOMA score was ≥1 during the screening period.
- All subjects and their partners were not planning to have a child from screening to the end of the trial and agreed to use effective non-drug contraception during the trial.
Who cannot join
- Patients with severe, progressive and uncontrollable diseases of the liver, blood, gastrointestinal tract, endocrine system, lungs, heart, nervous system, mental system or brain.
- Patients with allergic constitution or severe systemic autoimmune diseases.
- Patients with active massive gastrointestinal bleeding or acute intestinal obstruction during the screening period.
- Pregnant or lactating women.
- Patients with rectal stenosis or fistula formation that restricts endoscopic treatment and require surgical treatment.
- Patients with a LENT-SOMA score of 4 during the screening period.
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- Serum virology test (HBeAg, HCV antibody, HlV antibody, Treponema pallidum antibody) positive.
- Patients with uncontrolled tumors, tumor recurrence or metastasis.
- Subjects received any investigational drug within 3 months prior to the screening.
- Subjects received stem cell treatment.
- Participants considered inappropriate to participate in this clinical trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase l Clinical Study Evaluating the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Radiation Proctitis
A Phase l clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with Radiation proctitis
- Conditions
- Radiation Proctitis
- Being tested
- Mesenchymal Stem Cells (MSCs)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem Cells (MSCs)Drug
single dose injection (120 million cells)
| Study group | Role | What they receive |
|---|---|---|
| MSCs treatment group | Experimental | Not described Receives: Drug: Mesenchymal Stem Cells (MSCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radioactive distribution
The radioactive distribution in the injection site and various organs or tissues after local injection in patients with radiation proctitis
Measured: 8-12 hour、32-36 hour、 56-60 hour. 104-108 hour、152-156 hour, 296-300 hour
Secondary outcomes (3)
Safety endpoint: Treatment-related adverse events/adverse reactions, serious adverse events/serious adverse events
All subjects were observed for any adverse events/reactions or serious adverse events/reactions that occurred during the clinical trial, including but not limited to clinically significant abnormal changes in clinical symptoms, physical examination, vital signs examination, laboratory examination, 12- ead electrocardiogram examination, etc. The clinical features, severity, occurrence time, end time, treatment and outcome of the disease should be recorded, and the correlation between the disease and the investigational drug should be determined.
Measured: Week1, Week 4, Week 24，Month 24
Effectiveness endpoint:Clinical symptom assessment, endoscopic evaluation and clinical improvement.
The clinical symptom assessment adopts the LENT-SOMA score， total score ranges from 0 to 4, higher score means more severe symptoms.
The endoscopic evaluation adopts the Vienna Rectoscopy Score, The score range from 0 to 5 points. The highest score of each individual item is counted as the total VRS score. Higher the VRS score means more severe lesions.
Measured: Week 4，Week 24
Radiation exposure
The uptake rate (%ID), absorbed dose and whole-body effective dose of important organs or tissues after local injection administration of [89Zr] human-derived TH-SC01 cell injection.
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ProctitisStudies of the same condition, open and under way.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925607
- Sponsor's protocol ID
- TH-SC01-RP-Ⅰ-05
- Status last verified
- Mar 2025
- First submitted
- 7 Apr 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase l Clinical Study Evaluating the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Radiation Proctitis
- ClinicalTrials.gov ID
- NCT06925607
- Acronym / sponsor ID
- TH-SC01-RP-Ⅰ-05
- Conditions
- Radiation Proctitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Apr 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.
A Phase l clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with Radiation proctitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSCs treatment group | Experimental | Drug: Mesenchymal Stem Cells (MSCs) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent
- Good physical condition (WHO performance status score 0-1).
- Patient received radiotherapy after being pathologically diagnosed with pelvic malignant tumors
- Patient diagnosed with chronic radiation proctitis after undergoing colonoscopy more than 6 months after the completion of radiotherapy and did not respond to conventional treatment.
- The LENT-SOMA score was ≥1 during the screening period.
Key exclusion criteria (11 listed)
- Patients with severe, progressive and uncontrollable diseases of the liver, blood, gastrointestinal tract, endocrine system, lungs, heart, nervous system, mental system or brain.
- Patients with allergic constitution or severe systemic autoimmune diseases.
- Patients with active massive gastrointestinal bleeding or acute intestinal obstruction during the screening period.
- Pregnant or lactating women.
- Patients with rectal stenosis or fistula formation that restricts endoscopic treatment and require surgical treatment.
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 |
|---|---|---|
| Mesenchymal Stem Cells (MSCs)single dose injection (120 million cells) | Drug | MSCs treatment group |
Primary outcome
Radioactive distribution
Time frame: 8-12 hour、32-36 hour、 56-60 hour. 104-108 hour、152-156 hour, 296-300 hour
The radioactive distribution in the injection site and various organs or tissues after local injection in patients with radiation proctitis
3 secondary outcomes
Safety endpoint: Treatment-related adverse events/adverse reactions, serious adverse events/serious adverse events
Time frame: Week1, Week 4, Week 24，Month 24
Effectiveness endpoint:Clinical symptom assessment, endoscopic evaluation and clinical improvement.
Time frame: Week 4，Week 24
Radiation exposure
Time frame: Week 1
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 13 Apr 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mesenchymal Stem Cells (MSCs) in people with Radiation Proctitis, run by Jiangsu Topcel-KH Pharmaceutical Co., Ltd..
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 6 inclusion and 11 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 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Jueyu Xia, Master (025-52700103, xiajueyu@topcelbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radioactive distribution (time frame: 8-12 hour、32-36 hour、 56-60 hour. 104-108 hour、152-156 hour, 296-300 hour). 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 13 Apr 2025.