A Study of TH-SC01 in the Treatment of Radiation-induced Rectal Injury
- Conditions
- Rectal Injury
- Interventions
- Biological: TH-SC01(Umbilical cord mesenchymal stem cells)
- Registration Number
- NCT05939778
- Lead Sponsor
- Jinling Hospital, China
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 27
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TH-SC01 local injection treatment group 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.
- Primary Outcome Measures
Name Time Method lentsoma score scale improved > 0.6 points 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.
- Secondary Outcome Measures
Name Time Method The decreased levels of SF-36 Scale 16 weeks The quality of life of patients before and after treatment
The decreased levels of Hospital Anxiety and Depression Scales 16 weeks To assess the level of anxiety and depression in the subjects in the hospital
The declining level of the Vienna Rectoscopy Score 16 weeks 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.
The decreased level ofSemi-quantitative Score of Rectal Radiological Pathological Injury 16 weeks The histological severity of the rectal injury was assessed by colonoscopy. The most severe rating is 10
The decreased levels of Visual Analogue Pain Rating Scale 16 weeks 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.
Serious adverse event occurred 2 years Cases such as fever, allergy, pain, and severe bleeding should be recorded immediately and treated actively
The decreasing level of the Rectal Telangiectasia Density Scale(RTD) 16 weeks The degree of capillary dilatation at the lesion site was observed during colonoscopy. There were four grades, with the highest score being 3.
Trial Locations
- Locations (1)
Jinling Hospital, China
🇨🇳Nanjing, Jiangsu, China