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

NCT ID: NCT05939778

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-21
• Study Completion Date: 2026-01-21

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.

Conditions

Rectal Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TH-SC01 local injection treatment group

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.

Group Type: EXPERIMENTAL

TH-SC01(Umbilical cord mesenchymal stem cells)

Intervention Type: BIOLOGICAL

"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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Jinling Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fangyu Wang

Role: STUDY_CHAIR

Director of gastroenterology Department, Jinling Hospital

Locations

Jinling Hospital, China

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fangyu Wang

Role: CONTACT

quanguorenmin1994@163.com

0086-13515100636

Haoyu Xu

Role: CONTACT

quanguorenmin1994@163.com

0086-17362954983

Facility Contacts

Fangyu Wang

Role: primary

quanguorenmin1994@163.com

0086-13515100636

Other Identifiers

TH-SC01-RP-IIT-03

Identifier Type: -

Identifier Source: org_study_id