Rectal InjuryPhase 1NCT05939778
A Study of TH-SC01 in the Treatment of Radiation-induced Rectal Injury
A Phase 1 study testing TH-SC01(Umbilical cord mesenchymal stem cells) in people with Rectal Injury, run by Jinling Hospital, China at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of allogeneic umbilical cord mesenchymal stem cells in the treatment of radiation-induced rectal injury. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rectal Injury
- What is being tested?
- TH-SC01(Umbilical cord mesenchymal stem cells)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2022to 21 Jan 2026
- Phase
- Phase 1
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fully understand and sign the informed consent form;
- Age ≥18 years and <80 years;
- Patients diagnosed with chronic radiation rectal injury after radiation therapy;
- Patients with LENT-SOMA scale score ≥1;
- Good physical condition (WHO functional status score 0-1).
Who cannot join
- The patient had severe liver and kidney disease;
- Severe congestive heart failure or coronary heart disease;
- Patients have allergic constitutions or severe systemic immune diseases;
- The patient had active gastrointestinal hemorrhage or acute intestinal obstruction;
- Patients were pregnant or had other conditions that the investigators deemed unsuitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital, China
Nanjing, Jiangsu, 210000
Fangyu Wang, 0086-13515100636, quanguorenmin1994@163.com
About this study
Official title: A Study on the Efficacy and Safety of Endoscopic Local Injection of Umbilical Cord Mesenchymal Stem Cells（TH-SC01） for the Treatment of Radiation-induced Rectal Injury.
The purpose of this study is to evaluate the efficacy and safety of allogeneic umbilical cord mesenchymal stem cells in the treatment of radiation-induced rectal injury.
Read the detailed description
radiation-induced rectal injury (RRI) is a common clinical disease. The symptoms of RRI often include: Abdominal pain, diarrhea, hematochezia, etc., especially chronic radiation-induced late rectal injury (RLRI), are easy to cause the disease to prolong and not heal. Some patients will have severe complications such as massive rectal bleeding, rectal stenosis, intestinal obstruction, deep ulcer, intestinal perforation, and fistula formation after the disease progresses to the advanced stage, most of which occur 2-5 years after the end of radiotherapy. The incidence of radiation rectal injury is high, which has a serious impact on the health and quality of life of patients. Currently, the commonly used treatment methods include non-steroidal anti-inflammatory drugs, mucosal protective agents, hemostatic agents, compound enema preparations, hyperbaric oxygen, surgical treatment, etc., but there is still no standard treatment strategy and effective plan, and clinical treatment is extremely difficult.
Mesenchymal stem cells have the properties of proliferation, differentiation, immune regulation and angiogenesis. There are few clinical studies on the use of mesenchymal stem cells in the treatment of radiation-induced rectal injury. Good therapeutic effect was achieved in vivo and in vitro in the preliminary experiment. The aim of this study was to verify the safety and efficacy of allogeneic mesenchymal stem cells from healthy donors in RRI patients.
Primary objective: To assess the safety (incidence of treatment emergent adverse-events) of TH-SC01.
- Conditions
- Rectal Injury
- Being tested
- TH-SC01(Umbilical cord mesenchymal stem cells)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TH-SC01(Umbilical cord mesenchymal stem cells)Biological
"5+7" principle:
- In medium and high dose groups, 5 subjects were included in each dose group in the first step, and the first 3 subjects had good safety The investigator evaluated safety and efficacy data and could enroll a fourth and fifth subject.
- If the number of successful participants in these 5 subjects is less than 2, the study in this dose group will be ended due to drug ineffectiveness, and the researcher will evaluate the safety and enter the next dose group.
- If the number of successful participants in these 5 cases is greater than or equal to 2, then proceed to the second step.
- 7 subjects were included in the second step.
| Study group | Role | What they receive |
|---|---|---|
| TH-SC01 local injection treatment group | Experimental | The trial was conducted in a non-randomized, single-center, single-arm, dose-escalation design. Three dose groups were preset, which were as follows:
Low dose group: 3×10^7 live cells/person (6mL); Medium dose group: 6×10^7 live cells/person (12mL) ; High dose group: 1.2×10^8 live cells/person (24mL); Each subject should receive only one corresponding dose. Three subjects were enrolled in the low-dose group,If the safety of the subjects was good, the researchers evaluated the safety and efficacy data and entered the next dose group for treatment. The medium and high-dose groups were enrolled according to the "5+7" principle.
For the first 3 dose groups, after safety evaluation by the investigators, the maximum dose could reach 2.4×10^8 live cells/person (48mL). If the MTD group is not identified by the highest dose group, it is up to the investigator to decide whether to continue with dose escalation. Receives: Biological: TH-SC01(Umbilical cord mesenchymal stem cells) |
What is being measured
The primary outcome is the main question the study is designed to answer.
lentsoma score scale improved > 0.6 points
lentsoma scale can comprehensively reflect the severity of radiation-induced rectal injury from three aspects: subjective feeling, objective situation and intervention measures. There are 14 items in total, each item has a maximum of 4 points, and the final total is divided by 14.
Measured: 16 weeks
Secondary outcomes (7)
The decreasing level of the Rectal Telangiectasia Density Scale(RTD)
The degree of capillary dilatation at the lesion site was observed during colonoscopy. There were four grades, with the highest score being 3.
Measured: 16 weeks
The declining level of the Vienna Rectoscopy Score
The Vienna Rectoscopy Score evaluated the severity of the disease under colonoscopy in five aspects: the degree of telangiectasia, mucosal congestion, ulceration, stenosis, and necrosis. The most serious score is 5 points.
Measured: 16 weeks
The decreased level ofSemi-quantitative Score of Rectal Radiological Pathological Injury
The histological severity of the rectal injury was assessed by colonoscopy. The most severe rating is 10
Measured: 16 weeks
The decreased levels of SF-36 Scale
The quality of life of patients before and after treatment
Measured: 16 weeks
The decreased levels of Hospital Anxiety and Depression Scales
To assess the level of anxiety and depression in the subjects in the hospital
Measured: 16 weeks
The decreased levels of Visual Analogue Pain Rating Scale
The degree of pain is represented by a total of 11 numbers from 0 to 10, 0 means no pain, 10 represents the most pain, according to the degree of pain in the 11 numbers to select a number to represent the pain degree.
Measured: 16 weeks
Serious adverse event occurred
Cases such as fever, allergy, pain, and severe bleeding should be recorded immediately and treated actively
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start21 Sep 2022
- Primary completion21 Jan 2024 (estimated)
- Study completion21 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal InjuryStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Fangyu Wang, Study chair, Director of gastroenterology Department, Jinling Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939778
- Sponsor's protocol ID
- TH-SC01-RP-IIT-03
- Status last verified
- Sep 2022
- First submitted
- 2 Jul 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Safety of Endoscopic Local Injection of Umbilical Cord Mesenchymal Stem Cells（TH-SC01） for the Treatment of Radiation-induced Rectal Injury.
- ClinicalTrials.gov ID
- NCT05939778
- Acronym / sponsor ID
- TH-SC01-RP-IIT-03
- Conditions
- Rectal Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Collaborators
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 21 Jan 2024 (estimated)
- Study completion
- 21 Jan 2026 (estimated)
- First posted
- 11 Jul 2023 (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.
The purpose of this study is to evaluate the efficacy and safety of allogeneic umbilical cord mesenchymal stem cells in the treatment of radiation-induced rectal injury.
Detailed description
radiation-induced rectal injury (RRI) is a common clinical disease. The symptoms of RRI often include: Abdominal pain, diarrhea, hematochezia, etc., especially chronic radiation-induced late rectal injury (RLRI), are easy to cause the disease to prolong and not heal. Some patients will have severe complications such as massive rectal bleeding, rectal stenosis, intestinal obstruction, deep ulcer, intestinal perforation, and fistula formation after the disease progresses to the advanced stage, most of which occur 2-5 years after the end of radiotherapy. The incidence of radiation rectal injury is high, which has a serious impact on the health and quality of life of patients. Currently, the commonly used treatment methods include non-steroidal anti-inflammatory drugs, mucosal protective agents, hemostatic agents, compound enema preparations, hyperbaric oxygen, surgical treatment, etc., but there is still no standard treatment strategy and effective plan, and clinical treatment is extremely difficult.
Mesenchymal stem cells have the properties of proliferation, differentiation, immune regulation and angiogenesis. There are few clinical studies on the use of mesenchymal stem cells in the treatment of radiation-induced rectal injury. Good therapeutic effect was achieved in vivo and in vitro in the preliminary experiment. The aim of this study was to verify the safety and efficacy of allogeneic mesenchymal stem cells from healthy donors in RRI patients.
Primary objective: To assess the safety (incidence of treatment emergent adverse-events) of TH-SC01.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TH-SC01 local injection treatment group | Experimental | Biological: TH-SC01(Umbilical cord mesenchymal stem cells)The trial was conducted in a non-randomized, single-center, single-arm, dose-escalation design. Three dose groups were preset, which were as follows: Low dose group: 3×10^7 live cells/person (6mL); Medium dose group: 6×10^7 live cells/person (12mL) ; High dose group: 1.2×10^8 live cells/person (24mL); Each subject should receive only one corresponding dose. Three subjects were enrolled in the low-dose group,If the safety of the subjects was good, the researchers evaluated the safety and efficacy data and entered the next dose group for treatment. The medium and high-dose groups were enrolled according to the "5+7" principle. For the first 3 dose groups, after safety evaluation by the investigators, the maximum dose could reach 2.4×10^8 live cells/person (48mL). If the MTD group is not identified by the highest dose group, it is up to the investigator to decide whether to continue with dose escalation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fully understand and sign the informed consent form;
- Age ≥18 years and <80 years;
- Patients diagnosed with chronic radiation rectal injury after radiation therapy;
- Patients with LENT-SOMA scale score ≥1;
- Good physical condition (WHO functional status score 0-1).
Key exclusion criteria (5 listed)
- The patient had severe liver and kidney disease;
- Severe congestive heart failure or coronary heart disease;
- Patients have allergic constitutions or severe systemic immune diseases;
- The patient had active gastrointestinal hemorrhage or acute intestinal obstruction;
- Patients were pregnant or had other conditions that the investigators deemed unsuitable for inclusion in the study.
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 |
|---|---|---|
| TH-SC01(Umbilical cord mesenchymal stem cells)"5+7" principle: 1. In medium and high dose groups, 5 subjects were included in each dose group in the first step, and the first 3 subjects had good safety The investigator evaluated safety and efficacy data and could enroll a fourth and fifth subject. 1. If the number of successful participants in these 5 subjects is less than 2, the study in this dose group will be ended due to drug ineffectiveness, and the researcher will evaluate the safety and enter the next dose group. 2. If the number of successful participants in these 5 cases is greater than or equal to 2, then proceed to the second step. 2. 7 subjects were included in the second step. | Biological | TH-SC01 local injection treatment group |
Primary outcome
lentsoma score scale improved > 0.6 points
Time frame: 16 weeks
lentsoma scale can comprehensively reflect the severity of radiation-induced rectal injury from three aspects: subjective feeling, objective situation and intervention measures. There are 14 items in total, each item has a maximum of 4 points, and the final total is divided by 14.
7 secondary outcomes
The decreasing level of the Rectal Telangiectasia Density Scale(RTD)
Time frame: 16 weeks
The declining level of the Vienna Rectoscopy Score
Time frame: 16 weeks
The decreased level ofSemi-quantitative Score of Rectal Radiological Pathological Injury
Time frame: 16 weeks
The decreased levels of SF-36 Scale
Time frame: 16 weeks
The decreased levels of Hospital Anxiety and Depression Scales
Time frame: 16 weeks
The decreased levels of Visual Analogue Pain Rating Scale
Time frame: 16 weeks
Serious adverse event occurred
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- 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.
Fangyu Wang study chair
Director of gastroenterology Department, Jinling Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TH-SC01(Umbilical cord mesenchymal stem cells) in people with Rectal Injury, run by Jinling Hospital, China 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 5 inclusion and 5 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 11 Jul 2023. 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?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fangyu Wang (0086-13515100636, quanguorenmin1994@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lentsoma score scale improved > 0.6 points (time frame: 16 weeks). 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 11 Jul 2023.