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NCT Number: NCT06925607

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

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Key information

Conditions

Radiation Proctitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Mesenchymal Stem Cells (MSCs)

Drug

single dose injection (120 million cells)

Primary outcomes

  1. Radioactive distribution

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

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

Secondary outcomes

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

    Time frame: Week1, Week 4, Week 24，Month 24

    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.

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

    Time frame: Week 4，Week 24

    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.

  3. Radiation exposure

    Time frame: Week 1

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jueyu Xia, Master

CONTACT

[email protected]

025-52700103

Sponsors and collaborators

Lead sponsor

Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2025
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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