NCT05939778

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2026

Completed
Last Updated

July 11, 2023

Status Verified

September 1, 2022

Enrollment Period

1.3 years

First QC Date

July 2, 2023

Last Update Submit

July 10, 2023

Conditions

Rectal Injury

Outcome Measures

Primary Outcomes (1)

  • lentsoma score scale improved > 0.6 points

    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.

    16 weeks

Secondary Outcomes (7)

  • The decreasing level of the Rectal Telangiectasia Density Scale(RTD)

    16 weeks

  • The declining level of the Vienna Rectoscopy Score

    16 weeks

  • The decreased level ofSemi-quantitative Score of Rectal Radiological Pathological Injury

    16 weeks

  • The decreased levels of SF-36 Scale

    16 weeks

  • The decreased levels of Hospital Anxiety and Depression Scales

    16 weeks

  • +2 more secondary outcomes

Study Arms (1)

TH-SC01 local injection treatment group

EXPERIMENTAL

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.

Biological: TH-SC01(Umbilical cord mesenchymal stem cells)

Interventions

TH-SC01(Umbilical cord mesenchymal stem cells)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.

TH-SC01 local injection treatment group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinling Hospital, China

Nanjing, Jiangsu, 210000, China

RECRUITING

Study Officials

  • Fangyu Wang

    Director of gastroenterology Department, Jinling Hospital

    STUDY CHAIR

Central Study Contacts

Fangyu Wang

CONTACT

0086-13515100636quanguorenmin1994@163.com

Haoyu Xu

CONTACT

0086-17362954983quanguorenmin1994@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2023

First Posted

July 11, 2023

Study Start

September 21, 2022

Primary Completion

January 21, 2024

Study Completion

January 21, 2026

Last Updated

July 11, 2023

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)