Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis

NCT06438809 | Recruiting Phase 1

• 1 other identifier: TH-SC01-RP-I/II-03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I/II study to evaluate the safety and preliminary efficacy of human umbilical cord-derived mesenchymal stem cell injection for the treatment of chronic radiation proctitis.

Conditions

Chronic Radiation Proctitis

Outcome Measures

Primary Outcomes (2)

• The severity of adverse events after administration as assessed by CTCAE v5.0.

  Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 is a grading scale which can be utilized for adverse event (AE) reporting. It ranges from grade 1 (mild) to grade 5 (death related to AE) , and higher grade means the AE is more severe.

  28 days (1 month)

• The incidence of adverse events after administration.

  Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention.

  28 days (1 month)

Secondary Outcomes (9)

• The severity of adverse events after administration as assessed by CTCAE v5.0.

  112 days (4 month)

• The incidence of adverse events after administration.

  112 days (4 month)

• The recurrence of chronic radiation proctitis symptoms after administration.

  Day 112 (month 4)

• The deterioration of chronic radiation proctitis symptoms after administration.

  Day 112 (month 4)

• No improvement of chronic radiation proctitis symptoms after administration as assessed by LENT-SOMA score.

  Day 112 (month 4)

Study Arms (1)

Open label single arm study

EXPERIMENTAL

All patients will receive a single injection of umbilical cord-derived mesenchymal stem cells (120 million cells), and their therapeutic response will be monitored over a period of 24 months.

Biological: Mesenchymal Stem Cells (MSCs)

Interventions

Mesenchymal Stem Cells (MSCs) BIOLOGICAL

MSC suspension single does injection.

Open label single arm study

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully understand and sign the informed consent form;
• Age ≥18 years and \<80 years;
• Good physical condition (WHO performance status score 0-1);
• Pathologically diagnosed with pelvic malignant tumors and received radiotherapy;
• Diagnosed with chronic radiation proctitis after at least 6 months of endoscopic examination following the completion of radiotherapy and ineffective conventional treatment;
• Screening period LENT-SOMA score ≥1;
• Subjects and their spouses or partners have no plans for conception from screening to 6 months after the end of the trial, no plans for sperm or egg donation, and agree to use effective non-pharmacological contraceptive measures during the trial.

You may not qualify if:

• Patients with severe liver or kidney dysfunction during the screening period;
• Patients with severe congestive heart failure or coronary artery disease during the screening period;
• Patients with allergic constitution or severe systemic immune diseases;
• Patients with active gastrointestinal bleeding or acute intestinal obstruction during the screening period;
• Pregnant patients;
• Patients with rectal stenosis or fistula formation requiring surgical treatment that limits endoscopic therapy;
• Patients with a screening period LENT-SOMA score of 4;
• Patients with tumor recurrence or metastasis;
• Patients currently participating in other clinical trials at the time of screening or who have not been out of another clinical trial for less than 1 month;

Sponsors & Collaborators

• Jiangsu Topcel-KH Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 210016, China

RECRUITING

Central Study Contacts

Zhaoshen Li, MD

CONTACT

021-81873241; zhsl@vip.163.com

Study Design

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

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 3, 2024
• Study Start: May 24, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)