A Study of TH-SC01 in the Treatment of Radiation-induced Rectal Injury

Phase 1

Recruiting

• Conditions: Rectal Injury

• 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.

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09-21
• Study First Submitted: 2023-07-02
• Study First Submitted QC: 2023-07-10
• Last Update Submitted: 2023-07-10
• Study First Posted: 2023-07-11
• Last Update Posted: 2023-07-11
• Primary Completion: 2024-01-21
• Study Completion: 2026-01-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

1. Fully understand and sign the informed consent form;
2. Age ≥18 years and <80 years;
3. Patients diagnosed with chronic radiation rectal injury after radiation therapy;
4. Patients with LENT-SOMA scale score ≥1;
5. Good physical condition (WHO functional status score 0-1).

Exclusion Criteria

1. The patient had severe liver and kidney disease;
2. Severe congestive heart failure or coronary heart disease;
3. Patients have allergic constitutions or severe systemic immune diseases;
4. The patient had active gastrointestinal hemorrhage or acute intestinal obstruction;
5. 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

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