Clinical trial NCT06438809: Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis
Official title: Safety and Preliminary Efficacy of Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Chronic Radiation Proctitis
Lead sponsor: Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-06-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Fully understand and sign the informed consent form;
2. Age ≥18 years and \<80 years;
3. Good physical condition (WHO performance status score 0-1);
4. Pathologically diagnosed with pelvic malignant tumors and received radiotherapy;
5. Diagnosed with chronic radiation proctitis after at least 6 months of endoscopic examination following the completion of radiotherapy and ineffective conventional treatment;
6. Screening period LENT-SOMA score ≥1;
7. 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.

Exclusion Criteria:

1. Patients with severe liver or kidney dysfunction during the screening period;
2. Patients with severe congestive heart failure or coronary artery disease during the screening period;
3. Patients with allergic constitution or severe systemic immune diseases;
4. Patients with active gastrointestinal bleeding or acute intestinal obstruction during the screening period;
5. Pregnant patients;
6. Patients with rectal stenosis or fistula formation requiring surgical treatment that limits endoscopic therapy;
7. Patients with a screening period LENT-SOMA score of 4;
8. Patients with tumor recurrence or metastasis;
9. 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;
10. Other situations deemed unsuitable for inclusion in this study by the investigator.

Primary outcomes:
measure: The severity of adverse events after administration as assessed by CTCAE v5.0.
timeFrame: 28 days (1 month)
measure: The incidence of adverse events after administration.
timeFrame: 28 days (1 month)
Secondary outcomes:
measure: The severity of adverse events after administration as assessed by CTCAE v5.0.
timeFrame: 112 days (4 month)
measure: The incidence of adverse events after administration.
timeFrame: 112 days (4 month)
measure: The recurrence of chronic radiation proctitis symptoms after administration.
timeFrame: Day 112 (month 4)
measure: The deterioration of chronic radiation proctitis symptoms after administration.
timeFrame: Day 112 (month 4)
measure: No improvement of chronic radiation proctitis symptoms after administration as assessed by LENT-SOMA score.
timeFrame: Day 112 (month 4)
measure: No improvement of chronic radiation proctitis symptoms after administration as assessed by VRS.
timeFrame: Day 112 (month 4)
measure: No improvement of chronic radiation proctitis symptoms after administration as assessed by a semi-quantitative scoring system for radiotherapy-induced rectal pathological damage.
timeFrame: Day 112 (month 4)
measure: No improvement of chronic radiation proctitis symptoms after administration as assessed by a RTD grading scale.
timeFrame: Day 112 (month 4)
measure: No improvement of chronic radiation proctitis symptoms after administration as assessed by VAS score.
timeFrame: Day 112 (month 4)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
References: