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

Jiangsu Topcel-KH Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Radiation Proctitis

Treatments: Drug: Mesenchymal Stem Cells (MSCs)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06925607

TH-SC01-RP-Ⅰ-05

Details and patient eligibility

About

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

Enrollment: 6 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

MSCs treatment group

Experimental group

Treatment:

Drug: Mesenchymal Stem Cells (MSCs)