Actively Recruiting
Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis
Led by Jiangsu Topcel-KH Pharmaceutical Co., Ltd. · Updated on 2024-06-21
24
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand and sign the informed consent form
- Age 18 years or older and under 80 years
- Good physical condition with 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 completion of radiotherapy with ineffective conventional treatment
- Screening period LENT-SOMA score of 1 or higher
- Subjects and their partners have no plans for conception from screening to 6 months after the trial, no plans for sperm or egg donation, and agree to use effective non-pharmacological contraception during the trial
You will not qualify if you...
- Severe liver or kidney dysfunction during screening
- Severe congestive heart failure or coronary artery disease during screening
- Allergic constitution or severe systemic immune diseases
- Active gastrointestinal bleeding or acute intestinal obstruction during screening
- Pregnant patients
- Rectal stenosis or fistula requiring surgery that limits endoscopic therapy
- Screening period LENT-SOMA score of 4
- Tumor recurrence or metastasis
- Currently participating in other clinical trials or less than 1 month since last trial
- Other situations deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jinling Hospital
Nanjing, Jiangsu, China, 210016
Actively Recruiting
Research Team
Z
Zhaoshen Li, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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