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

A Phase l Clinical Study Evaluating the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Radiation Proctitis

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

Study Overview

• Status: Not yet recruiting
• Conditions: Radiation Proctitis
• Intervention / Treatment: Drug: Mesenchymal Stem Cells (MSCs)

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jueyu Xia, Master; Phone Number: 025-52700103; Email: xiajueyu@topcelbio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signed informed consent
2. Good physical condition (WHO performance status score 0-1).
3. Patient received radiotherapy after being pathologically diagnosed with pelvic malignant tumors
4. 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.
5. The LENT-SOMA score was ≥1 during the screening period.
6. 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MSCs treatment group	Drug: Mesenchymal Stem Cells (MSCs); single dose injection (120 million cells)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoint: Treatment-related adverse events/adverse reactions, serious adverse events/serious adverse events	All subjects were observed for any adverse events/reactions or serious adverse events/reactions that occurred during the clinical trial, including but not limited to clinically significant abnormal changes in clinical symptoms, physical examination, vital signs examination, laboratory examination, 12- ead electrocardiogram examination, etc. The clinical features, severity, occurrence time, end time, treatment and outcome of the disease should be recorded, and the correlation between the disease and the investigational drug should be determined.	Week1, Week 4, Week 24，Month 24
Effectiveness endpoint:Clinical symptom assessment, endoscopic evaluation and clinical improvement.	The clinical symptom assessment adopts the LENT-SOMA score， total score ranges from 0 to 4, higher score means more severe symptoms. The endoscopic evaluation adopts the Vienna Rectoscopy Score, The score range from 0 to 5 points. The highest score of each individual item is counted as the total VRS score. Higher the VRS score means more severe lesions.	Week 4，Week 24
Radiation exposure	The uptake rate (%ID), absorbed dose and whole-body effective dose of important organs or tissues after local injection administration of [89Zr] human-derived TH-SC01 cell injection.	Week 1

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Gastroenteritis; Proctitis
• Other Study ID Numbers: TH-SC01-RP-Ⅰ-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No