Evaluate the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Radiation Proctitis

NCT06925607 | Not Yet Recruiting Phase 1

• 1 other identifier: TH-SC01-RP-Ⅰ-05
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Phase l clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with Radiation proctitis

Conditions

Radiation Proctitis

Outcome Measures

Primary Outcomes (1)

• Radioactive distribution

  The radioactive distribution in the injection site and various organs or tissues after local injection in patients with radiation proctitis

  8-12 hour、32-36 hour、 56-60 hour. 104-108 hour、152-156 hour, 296-300 hour

Secondary Outcomes (3)

• Safety endpoint: Treatment-related adverse events/adverse reactions, serious adverse events/serious adverse events

  Week1, Week 4, Week 24，Month 24

• Effectiveness endpoint:Clinical symptom assessment, endoscopic evaluation and clinical improvement.

  Week 4，Week 24

• Radiation exposure

  Week 1

Study Arms (1)

MSCs treatment group

EXPERIMENTAL

Drug: Mesenchymal Stem Cells (MSCs)

Interventions

Mesenchymal Stem Cells (MSCs) DRUG

single dose injection (120 million cells)

MSCs treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Good physical condition (WHO performance status score 0-1).
• Patient received radiotherapy after being pathologically diagnosed with pelvic malignant tumors
• Patient diagnosed with chronic radiation proctitis after undergoing colonoscopy more than 6 months after the completion of radiotherapy and did not respond to conventional treatment.
• The LENT-SOMA score was ≥1 during the screening period.
• All subjects and their partners were not planning to have a child from screening to the end of the trial and agreed to use effective non-drug contraception during the trial.

You may not qualify if:

• Patients with severe, progressive and uncontrollable diseases of the liver, blood, gastrointestinal tract, endocrine system, lungs, heart, nervous system, mental system or brain.
• Patients with allergic constitution or severe systemic autoimmune diseases.
• Patients with active massive gastrointestinal bleeding or acute intestinal obstruction during the screening period.
• Pregnant or lactating women.
• Patients with rectal stenosis or fistula formation that restricts endoscopic treatment and require surgical treatment.
• Patients with a LENT-SOMA score of 4 during the screening period.
• Serum virology test (HBeAg, HCV antibody, HlV antibody, Treponema pallidum antibody) positive.
• Patients with uncontrolled tumors, tumor recurrence or metastasis.
• Subjects received any investigational drug within 3 months prior to the screening.
• Subjects received stem cell treatment.
• Participants considered inappropriate to participate in this clinical trial

Sponsors & Collaborators

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

Central Study Contacts

Jueyu Xia, Master

CONTACT

025-52700103; xiajueyu@topcelbio.com

Study Design

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

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 13, 2025
• Study Start: April 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2025

Record last verified: 2025-03