Safety and Preliminary Efficacy of Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The severity of adverse events after administration as assessed by CTCAE v5.0.
研究概览
简要总结
A Phase I/II study to evaluate the safety and preliminary efficacy of human umbilical cord-derived mesenchymal stem cell injection for the treatment of chronic radiation proctitis.
详细描述
Radiation therapy is frequently used to treat pelvic cancers such as anal, cervical, prostate, and rectal cancer. While effective in controlling local tumors, it can also cause collateral damage to the gastrointestinal tract. The rectum is particularly vulnerable to radiation damage due to its fixed position in the pelvis. In the acute phase, radiation can lead to proctitis, an inflammatory condition characterized by mucosal ulceration, edema, and loss of microvilli. Patients typically present within three months of radiation therapy with symptoms like diarrhea, urgency, and tenesmus. Chronic radiation proctitis can either follow the acute phase or appear after a symptom-free period, typically 8 to 12 months post-radiation treatment. This chronic condition results from radiation-induced small-vessel injury, causing ischemia, obliterative endarteritis, fibrosis, and neovascularization. Rectal bleeding is a common symptom of chronic radiation proctitis.
Clinical studies have demonstrated that mesenchymal stem cell (MSC) treatment offers significant benefits, including anti-inflammatory, immune modulation, and tissue repair effects. Recent research indicates that intralesional injection of MSC is effective in treating radiation proctitis, reducing pain and bleeding without causing severe adverse events. This suggests that MSC treatment could be a promising option for radiation proctitis.
This is a phase I/II study designed to evaluate the safety and preliminary efficacy of MSC treatment for radiation proctitis. Patients will be followed up for 24 months after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully understand and sign the informed consent form;
- •Age ≥18 years and <80 years;
- •Good physical condition (WHO performance status score 0-1);
- •Pathologically diagnosed with pelvic malignant tumors and received radiotherapy;
- •Diagnosed with chronic radiation proctitis after at least 6 months of endoscopic examination following the completion of radiotherapy and ineffective conventional treatment;
- •Screening period LENT-SOMA score ≥1;
- •Subjects and their spouses or partners have no plans for conception from screening to 6 months after the end of the trial, no plans for sperm or egg donation, and agree to use effective non-pharmacological contraceptive measures during the trial.
排除标准
- •Patients with severe liver or kidney dysfunction during the screening period;
- •Patients with severe congestive heart failure or coronary artery disease during the screening period;
- •Patients with allergic constitution or severe systemic immune diseases;
- •Patients with active gastrointestinal bleeding or acute intestinal obstruction during the screening period;
- •Pregnant patients;
- •Patients with rectal stenosis or fistula formation requiring surgical treatment that limits endoscopic therapy;
- •Patients with a screening period LENT-SOMA score of 4;
- •Patients with tumor recurrence or metastasis;
- •Patients currently participating in other clinical trials at the time of screening or who have not been out of another clinical trial for less than 1 month;
- •Other situations deemed unsuitable for inclusion in this study by the investigator.
结局指标
主要结局
The severity of adverse events after administration as assessed by CTCAE v5.0.
时间窗: 28 days (1 month)
Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 is a grading scale which can be utilized for adverse event (AE) reporting. It ranges from grade 1 (mild) to grade 5 (death related to AE) , and higher grade means the AE is more severe.
The incidence of adverse events after administration.
时间窗: 28 days (1 month)
Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention.
次要结局
- The severity of adverse events after administration as assessed by CTCAE v5.0.(112 days (4 month))
- The recurrence of chronic radiation proctitis symptoms after administration.(Day 112 (month 4))
- The incidence of adverse events after administration.(112 days (4 month))
- The deterioration of chronic radiation proctitis symptoms after administration.(Day 112 (month 4))
- No improvement of chronic radiation proctitis symptoms after administration as assessed by a RTD grading scale.(Day 112 (month 4))
- No improvement of chronic radiation proctitis symptoms after administration as assessed by a semi-quantitative scoring system for radiotherapy-induced rectal pathological damage.(Day 112 (month 4))
- No improvement of chronic radiation proctitis symptoms after administration as assessed by VAS score.(Day 112 (month 4))
- No improvement of chronic radiation proctitis symptoms after administration as assessed by LENT-SOMA score.(Day 112 (month 4))
- No improvement of chronic radiation proctitis symptoms after administration as assessed by VRS.(Day 112 (month 4))