Crohn's Disease
Conditions
Interventions
Experimental group:UCMSC-Exo Injection
UCMSC-Exo Enteric-Coated Capsules.
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Medical History Requirements: Patients aged 18-60 years, diagnosed with Crohn's Disease (CD) for more than six months, and presenting with complex anal fistulas that are uncontrolled or intolerant to at least one advanced therapy (biologics or small-molecule drugs). 2.Active Fistula Score: Patients must have an active perianal disease activity index (Perianal Disease Activity Index, PDAI > 4) at the time of enrollment and meet the diagnostic criteria for complex anal fistulas. 3.Follow-up Commitment: Willingness to undergo regular outpatient or telephone follow-ups after discharge. 4.Pregnancy Test: Female participants must have a negative (blood or urine) pregnancy test.
Exclusion criteria
Exclusion criteria: 1. Rectal or anal stricture; 2. Active severe proctitis: defined as the presence of extensive superficial or deep ulcers, which may affect the healing of the postoperative fistula; 3. Perianal abscess >=2 cm in diameter; 4. Have not received treatment for anal fistula in Crohn's disease in the past; 5. Treatment with corticosteroids within the past 4 weeks; 6. Allergy to MSC-Exos or related ingredients; 7. Combined with serious infection or other uncontrollable systemic diseases; 8. Pregnant or lactating women; 9. Unwillingness to accept measures to avoid pregnancy; 10. Patients who have participated in other clinical trials within 4 weeks; 11. Other reasons why the investigator evaluation cannot be selected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PDAI score and clinical fistula healing rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Abdominal pain score (APS) ;MRI fistula activity score;Frequency of loose or watery stools (SF);S-IBDQ (Simplified Inflammatory Bowel Disease Questionnaire) scores.; | — |
Countries
China
Contacts
Public ContactWeifeng Huang
The First Affiliated Hospital of Xiamen University
Outcome results
None listed