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Not yet recruitingNCT06925607Updated Apr 13, 2025

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

A Phase 1 interventional study of Mesenchymal Stem Cells (MSCs) in Radiation Proctitis, sponsored by Jiangsu Topcel-KH Pharmaceutical Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-13.

Sponsored by Jiangsu Topcel-KH Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

02

Conditions studied

  • Radiation Proctitis

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03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (estimated)

Study arms

  • Experimental
    MSCs treatment group

    Drug: Mesenchymal Stem Cells (MSCs)

Interventions

  • DrugMesenchymal Stem Cells (MSCs)

    single dose injection (120 million cells)

05

What researchers measure

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

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

Secondary outcomes

  1. 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.

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

  2. 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.

    Time frame: Week 4，Week 24

  3. 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.

    Time frame: Week 1

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT06925607
Lead sponsor
Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Apr 13, 2025
Start date
Apr 2025 (estimated)
Primary completion
Mar 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Apr 13, 2025

Study contacts

Jueyu Xia, Master
Contact
xiajueyu@topcelbio.com
025-52700103

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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