complicated anal fistula
Conditions
Interventions
Treatment:Adipose derived stem cells
Control:Regular operation
Sponsors
Nanjing municipal hospital of chinese medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects of either sex aged over 18 years; 2. Signed informed consent; 3. Subjects with complex anal fistula diagnosed at least 12 months earlier and with one prior surgery; 4. Good general state of health according to the findings of the clinical history and the physical examination.
Exclusion criteria
Exclusion criteria: 1. Presence of severe proctitis or dominant active luminal disease requiring immediate therapy, assessed by rectosigmoidoscopy; 2. Subjects with an abscess; 3. The presence of setons unless removed prior to treatment start; 4. Subjects with rectal and/or anal stenosis; 5. Subjects who have received infliximab or any other anti-TNF agent in the 8 weeks before the cell treatment administration; 6. Subjects who have received tracrolimus or ciclosporine in the 4 weeks before the cell treatment administration. 7. Subjects with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion; 8. Subjects with malignant tumor, except for basal cell or cutaneous squamous cell carcinoma, or Subjects with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years. 9. Subjects with cardiopulmonary disease; 10. Subjects with any type of medical or psychiatric disease. 11. Subjects with congenital or acquired immunodeficiencies; 12. Subjects with abnormal laboratory test findings that contraindicate their inclusion in the study; 13. Subjects allergic to anesthetics or MRI contrast; 14. MRI is unfeasible, (e.g. due to the presence of pacemakers, hip replacements or severe claustrophobia); 15. Subjects in need of surgery in the perianal region for reasons other than fistulas at the time of inclusion in the study, or a need for such surgery is foreseen in this region in the 26 weeks after treatment administration; 16. Subjects who have suffered major surgery or severe trauma in the prior 6 months; 17. Pregnant or breastfeeding women; 18. Subjects currently receiving, or having received within 1 month prior to enrolment into this clinical trial, any investigational drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Life quality;Pain degree;anal sphincter function;Wound healing time and recovery rate;Recurrence time and recurrence rate;evalution by MRI; | — |
Countries
China
Contacts
Public ContactBin Jiang
Nanjing municipal hospital of chinese medicine
Outcome results
None listed