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

Официальное название

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

Обзор

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

Вмешательства

• Препарат Mesenchymal Stem Cells (MSCs)
  single dose injection (120 million cells)

Первичные конечные точки

• Radioactive distribution [Срок оценки: 8-12 hour、32-36 hour、 56-60 hour. 104-108 hour、152-156 hour, 296-300 hour]

Вторичные конечные точки (3)

• Safety endpoint: Treatment-related adverse events/adverse reactions, serious adverse events/serious adverse events [Срок оценки: Week1, Week 4, Week 24，Month 24]
• Effectiveness endpoint:Clinical symptom assessment, endoscopic evaluation and clinical improvement. [Срок оценки: Week 4，Week 24]
• Radiation exposure [Срок оценки: Week 1]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06925607 · TH-SC01-RP-Ⅰ-05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗