Refractory radiation rectal injury
Conditions
Interventions
Treatment group:Human umbilical cord mesenchymal stem cell exosomes
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Able to understand and willing to sign the informed consent form; 2. 18 years old= after the end of radiotherapy), and the tumor was well controlled >= 6 months;Those who have not responded/ineffective to existing treatments; 4. Diagnosed with Grade 2 or above radiation enteritis according to the CTCAE5.0 radiation enteritis grading criteria in the "Diagnosis and Treatment of Radiation Intestinal Injury" combined with imaging manifestations, and meet the following conditions: (1) Patients with a history of pelvic irradiation (including patients with radiotherapy alone, concurrent chemoradiotherapy or sequential/concurrent immunization therapy); (2) Intestinal changes under colonoscopy are mainly telangiectasia, mucosal hyperemia, ulcer, stenosis, necrosis, according to the Vienna colonoscopy score of telangiectasia, mucosal irrigation, ulcer, stenosis grade 2 or above and/or intestinal mucosal necrosis; 5. Subject life expectancy >= 12 weeks (as judged by the investigator); 6. Female subjects (blood or urine) have a negative pregnancy test and have started participating in the clinical study for at least 6 months; 7. Willing to receive regular outpatient or telephone follow-up after discharge;
Exclusion criteria
Exclusion criteria: 1. Severe cardiac insufficiency, cardiac ejection fraction EF less than 60% or severe arrhythmia; 2. Severe impaired liver function, liver function indexes (ALT, TBIL) greater than 3 times of the upper limit of normal (ULN); 3. Previous history of intestinal tumors; 4. Patients who have participated in other clinical trials within 4 weeks; 5. Subjects with a history of mental illness or at risk of suicide, with a history of epilepsy or other central nervous system diseases; 6. Suspected or confirmed history of alcohol and drug abuse; 7. ECOG score >= 2 points; 8. Those who are allergic to mesenchymal stem cell exosomes or allergic constitution 9. Other reasons why the investigator evaluation cannot be selected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate of clinical symptoms;Mucosal changes on electronic colonoscopy;Hemoglobin changes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-evaluation;Changes in the distribution of intestinal microbiota;Changes in inflammatory factors; | — |
Countries
China
Contacts
Public ContactQin Lin
The First Affiliated Hospital of Xiamen University
Outcome results
None listed