Clinical trial NCT05939778: A Study of TH-SC01 in the Treatment of Radiation-induced Rectal Injury
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Rectal Injury
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
Collaborators: name: Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
First posted: 2023-07-11
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: lentsoma score scale improved > 0.6 points
timeFrame: 16 weeks
Secondary outcomes:
measure: The decreasing level of the Rectal Telangiectasia Density Scale(RTD)
timeFrame: 16 weeks
measure: The declining level of the Vienna Rectoscopy Score
timeFrame: 16 weeks
measure: The decreased level ofSemi-quantitative Score of Rectal Radiological Pathological Injury
timeFrame: 16 weeks
measure: The decreased levels of SF-36 Scale
timeFrame: 16 weeks
measure: The decreased levels of Hospital Anxiety and Depression Scales
timeFrame: 16 weeks
measure: The decreased levels of Visual Analogue Pain Rating Scale
timeFrame: 16 weeks
measure: Serious adverse event occurred
timeFrame: 2 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital, China
state: Jiangsu
Study officials:
affiliation: Director of gastroenterology Department, Jinling Hospital
name: Fangyu Wang
role: STUDY_CHAIR
References: