Chronic Radiation ProctitisPhase 1/2NCT06438809
Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis
A Phase 1/2 study testing Mesenchymal Stem Cells (MSCs) in people with Chronic Radiation Proctitis, run by Jiangsu Topcel-KH Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
A Phase I/II study to evaluate the safety and preliminary efficacy of human umbilical cord-derived mesenchymal stem cell injection for the treatment of chronic radiation proctitis. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Chronic 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
- 24 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2024to May 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand and sign the informed consent form;
- Age ≥18 years and <80 years;
- Good physical condition (WHO performance status score 0-1);
- Pathologically diagnosed with pelvic malignant tumors and received radiotherapy;
- Diagnosed with chronic radiation proctitis after at least 6 months of endoscopic examination following the completion of radiotherapy and ineffective conventional treatment;
- Screening period LENT-SOMA score ≥1;
- Subjects and their spouses or partners have no plans for conception from screening to 6 months after the end of the trial, no plans for sperm or egg donation, and agree to use effective non-pharmacological contraceptive measures during the trial.
Who cannot join
- Patients with severe liver or kidney dysfunction during the screening period;
- Patients with severe congestive heart failure or coronary artery disease during the screening period;
- Patients with allergic constitution or severe systemic immune diseases;
- Patients with active gastrointestinal bleeding or acute intestinal obstruction during the screening period;
- Pregnant patients;
- Patients with rectal stenosis or fistula formation requiring surgical treatment that limits endoscopic therapy;
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- Patients with a screening period LENT-SOMA score of 4;
- Patients with tumor recurrence or metastasis;
- Patients currently participating in other clinical trials at the time of screening or who have not been out of another clinical trial for less than 1 month;
- Other situations deemed unsuitable for inclusion in this study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital
Nanjing, Jiangsu, 210016
Haoyu Xu, BD, 19895883608, quanguorenmin1994@163.com
About this study
Official title: Safety and Preliminary Efficacy of Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis
A Phase I/II study to evaluate the safety and preliminary efficacy of human umbilical cord-derived mesenchymal stem cell injection for the treatment of chronic radiation proctitis.
Read the detailed description
Radiation therapy is frequently used to treat pelvic cancers such as anal, cervical, prostate, and rectal cancer. While effective in controlling local tumors, it can also cause collateral damage to the gastrointestinal tract. The rectum is particularly vulnerable to radiation damage due to its fixed position in the pelvis. In the acute phase, radiation can lead to proctitis, an inflammatory condition characterized by mucosal ulceration, edema, and loss of microvilli. Patients typically present within three months of radiation therapy with symptoms like diarrhea, urgency, and tenesmus. Chronic radiation proctitis can either follow the acute phase or appear after a symptom-free period, typically 8 to 12 months post-radiation treatment. This chronic condition results from radiation-induced small-vessel injury, causing ischemia, obliterative endarteritis, fibrosis, and neovascularization. Rectal bleeding is a common symptom of chronic radiation proctitis.
Clinical studies have demonstrated that mesenchymal stem cell (MSC) treatment offers significant benefits, including anti-inflammatory, immune modulation, and tissue repair effects. Recent research indicates that intralesional injection of MSC is effective in treating radiation proctitis, reducing pain and bleeding without causing severe adverse events. This suggests that MSC treatment could be a promising option for radiation proctitis.
This is a phase I/II study designed to evaluate the safety and preliminary efficacy of MSC treatment for radiation proctitis. Patients will be followed up for 24 months after treatment.
- Conditions
- Chronic 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)Biological
MSC suspension single does injection.
| Study group | Role | What they receive |
|---|---|---|
| Open label single arm study | Experimental | All patients will receive a single injection of umbilical cord-derived mesenchymal stem cells (120 million cells), and their therapeutic response will be monitored over a period of 24 months. Receives: Biological: Mesenchymal Stem Cells (MSCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity of adverse events after administration as assessed by CTCAE v5.0.
Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 is a grading scale which can be utilized for adverse event (AE) reporting. It ranges from grade 1 (mild) to grade 5 (death related to AE) , and higher grade means the AE is more severe.
Measured: 28 days (1 month)
The incidence of adverse events after administration.
Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention.
Measured: 28 days (1 month)
Secondary outcomes (9)
The severity of adverse events after administration as assessed by CTCAE v5.0.
Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 is a grading scale which can be utilized for adverse event (AE) reporting. It ranges from grade 1 (mild) to grade 5 (death related to AE) , and higher grade means the AE is more severe.
Measured: 112 days (4 month)
The incidence of adverse events after administration.
Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention.
Measured: 112 days (4 month)
The recurrence of chronic radiation proctitis symptoms after administration.
The recurrence means that subjects who were previously cured or relieved are diagnosed again by the investigator, clinically, as having chronic radiation proctitis.
Measured: Day 112 (month 4)
The deterioration of chronic radiation proctitis symptoms after administration.
The deterioration means that the symptoms of chronic radiation proctitis have worsened compared to baseline.
Measured: Day 112 (month 4)
No improvement of chronic radiation proctitis symptoms after administration as assessed by LENT-SOMA score.
The Late Effects Normal Tissue/Subjective Objective Management Analytic (LENT/SOMA) is used for grading radiation therapy (RT)-induced side effects. It is graded on a 4-point scale ranging from occasional (score of 1) to refractory (score of 4), with a higher score indicating more severe disease. No improvement means no improvement of the score comparing to the baseline level.
Measured: Day 112 (month 4)
No improvement of chronic radiation proctitis symptoms after administration as assessed by VRS.
The Vienna Rectoscopy Score (VRS) is a feasible and effective tool for detecting and classifying pathological changes in the rectal mucosa after radiotherapy (RT). It is graded on a 5-point scale, ranging from 0 to 5, with a higher score indicating more severe disease. No improvement means that the score does not improve compared to the baseline level.
Measured: Day 112 (month 4)
No improvement of chronic radiation proctitis symptoms after administration as assessed by a semi-quantitative scoring system for radiotherapy-induced rectal pathological damage.
A specific scoring system that assesses the intensity of morphological features has been developed. The total score ranging from 0 to 10 , and a higher score indicates more severe disease. No improvement means that the score does not improve compared to the baseline level.
Measured: Day 112 (month 4)
No improvement of chronic radiation proctitis symptoms after administration as assessed by a RTD grading scale.
The rectal telangiectasia density (RTD) grading scale ranges from 0 to 3, and a higher score indicates the disease is more severe. No improvement means that the score does not improve compared to the baseline level.
Measured: Day 112 (month 4)
No improvement of chronic radiation proctitis symptoms after administration as assessed by VAS score.
The Visual Analogue Scale (VAS) is commonly used to assess the intensity of a patient's pain, ranging from none to extreme. It is graded on an 11-point scale,ranging from 0 to 10,with higher scores indicating more severe pain. No improvement means that the score does not improve compared to the baseline level.
Measured: Day 112 (month 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start24 May 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT06438809
- Sponsor's protocol ID
- TH-SC01-RP-I/II-03
- Status last verified
- Jun 2024
- First submitted
- 23 May 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Preliminary Efficacy of Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis
- ClinicalTrials.gov ID
- NCT06438809
- Acronym / sponsor ID
- TH-SC01-RP-I/II-03
- Conditions
- Chronic Radiation Proctitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 May 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 3 Jun 2024 (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 I/II study to evaluate the safety and preliminary efficacy of human umbilical cord-derived mesenchymal stem cell injection for the treatment of chronic radiation proctitis.
Detailed description
Radiation therapy is frequently used to treat pelvic cancers such as anal, cervical, prostate, and rectal cancer. While effective in controlling local tumors, it can also cause collateral damage to the gastrointestinal tract. The rectum is particularly vulnerable to radiation damage due to its fixed position in the pelvis. In the acute phase, radiation can lead to proctitis, an inflammatory condition characterized by mucosal ulceration, edema, and loss of microvilli. Patients typically present within three months of radiation therapy with symptoms like diarrhea, urgency, and tenesmus. Chronic radiation proctitis can either follow the acute phase or appear after a symptom-free period, typically 8 to 12 months post-radiation treatment. This chronic condition results from radiation-induced small-vessel injury, causing ischemia, obliterative endarteritis, fibrosis, and neovascularization. Rectal bleeding is a common symptom of chronic radiation proctitis.
Clinical studies have demonstrated that mesenchymal stem cell (MSC) treatment offers significant benefits, including anti-inflammatory, immune modulation, and tissue repair effects. Recent research indicates that intralesional injection of MSC is effective in treating radiation proctitis, reducing pain and bleeding without causing severe adverse events. This suggests that MSC treatment could be a promising option for radiation proctitis.
This is a phase I/II study designed to evaluate the safety and preliminary efficacy of MSC treatment for radiation proctitis. Patients will be followed up for 24 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label single arm study | Experimental | Biological: Mesenchymal Stem Cells (MSCs)All patients will receive a single injection of umbilical cord-derived mesenchymal stem cells (120 million cells), and their therapeutic response will be monitored over a period of 24 months. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Fully understand and sign the informed consent form;
- Age ≥18 years and <80 years;
- Good physical condition (WHO performance status score 0-1);
- Pathologically diagnosed with pelvic malignant tumors and received radiotherapy;
- Diagnosed with chronic radiation proctitis after at least 6 months of endoscopic examination following the completion of radiotherapy and ineffective conventional treatment;
Key exclusion criteria (10 listed)
- Patients with severe liver or kidney dysfunction during the screening period;
- Patients with severe congestive heart failure or coronary artery disease during the screening period;
- Patients with allergic constitution or severe systemic immune diseases;
- Patients with active gastrointestinal bleeding or acute intestinal obstruction during the screening period;
- Pregnant patients;
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)MSC suspension single does injection. | Biological | Open label single arm study |
Primary outcome
The severity of adverse events after administration as assessed by CTCAE v5.0.
Time frame: 28 days (1 month)
Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 is a grading scale which can be utilized for adverse event (AE) reporting. It ranges from grade 1 (mild) to grade 5 (death related to AE) , and higher grade means the AE is more severe.
The incidence of adverse events after administration.
Time frame: 28 days (1 month)
Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention.
9 secondary outcomes
The severity of adverse events after administration as assessed by CTCAE v5.0.
Time frame: 112 days (4 month)
The incidence of adverse events after administration.
Time frame: 112 days (4 month)
The recurrence of chronic radiation proctitis symptoms after administration.
Time frame: Day 112 (month 4)
The deterioration of chronic radiation proctitis symptoms after administration.
Time frame: Day 112 (month 4)
No improvement of chronic radiation proctitis symptoms after administration as assessed by LENT-SOMA score.
Time frame: Day 112 (month 4)
No improvement of chronic radiation proctitis symptoms after administration as assessed by VRS.
Time frame: Day 112 (month 4)
No improvement of chronic radiation proctitis symptoms after administration as assessed by a semi-quantitative scoring system for radiotherapy-induced rectal pathological damage.
Time frame: Day 112 (month 4)
No improvement of chronic radiation proctitis symptoms after administration as assessed by a RTD grading scale.
Time frame: Day 112 (month 4)
No improvement of chronic radiation proctitis symptoms after administration as assessed by VAS score.
Time frame: Day 112 (month 4)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mesenchymal Stem Cells (MSCs) in people with Chronic Radiation Proctitis, run by Jiangsu Topcel-KH Pharmaceutical Co., Ltd. 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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 21 Jun 2024. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaoshen Li, MD (021-81873241, zhsl@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The severity of adverse events after administration as assessed by CTCAE v5.0. (time frame: 28 days (1 month)). The study lists 2 primary outcomes in all. 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 21 Jun 2024.