Clinical trial
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.
Name
TH-SC01-RP-IIT-03
Description
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.
Trial arms
Trial start
2022-09-21
Estimated PCD
2024-01-21
Trial end
2026-01-21
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
TH-SC01 local injection treatment group
Size
27
Primary endpoint
lentsoma score scale improved > 0.6 points
16 weeks
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 27, 'type': 'ESTIMATED'}}
Updated at
2023-07-11
1 organization
Organization
Jinling Hospital