Refractory Anal Fistula (resistant to standard treatments including surgery, antibiotics, immunosupp Anal Fistula
Conditions
Interventions
Note:
Steps 1 to 9 below are planned to be performed at the time of implantation of the investigational device in conjunction with the fistula drainage procedure and, in principle, are to be conducte
D044968
Regenerative Medicine
Sponsors
Oda Tatsuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Presence of a complex anal fistula; 2. Insufficient response to existing standard treatments (including surgery, antibiotics, immunosuppressive agents, and biologic therapies); 3. Ability to undergo preparatory procedures for the fistula, such as curettage; 4. Scheduled to undergo elective surgery; 5. Age between 18 and 80 years (inclusive) at the time of obtaining informed consent; 6. Adequate organ function confirmed by clinical laboratory tests performed within 30 days prior to enrollment; - White blood cell count > 3000 /uL - Hemoglobin > 8.0 g/dL - Platelet count > 10 x 10^4 /uL - Total bilirubin < 2.0 mg/dL - AST (GOT) < 100 U/L - ALT (GPT) < 100 U/L - Serum creatinine < 1.5 mg/dL 7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; 8. Provision of written informed consent to participate in this study of the subject's own free will.
Exclusion criteria
Exclusion criteria: 1) Requirement for emergency surgery; 2) Patients receiving dialysis; 3) Presence of active severe enteritis; 4) Excessive immunosuppressed state (defined as systemic steroid administration equivalent to prednisolone >= 20 mg/day for 2 consecutive weeks or longer); 5) Metal allergy; 6) Determination by the treating physician that the subject is unsuitable for enrollment in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedure completion rate from BCM1 implantation to application at the target site (anal fistula tract) (Procedure completion in this study is defined as successful achievement of all of the following sequential steps: implantation of the device, formation of the bio-cocktail tissue, retrieval of the device, intended use of the formed bio-cocktail tissue, and engraftment at the target site.) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Proportion of subjects in whom bio-cocktail tissue was successfully formed 2) Area and weight of the harvested bio-cocktail tissue 3) Proportion of subjects achieving clinical closure at 4, 8, 12, 16, 20, and 24 weeks after filling *1 4) Proportion of subjects achieving radiological closure on MRI at 24 weeks after filling *2 5) Fistula reduction rate at 4, 8, 12, 16, 20, and 24 weeks after filling 6) Rate of seton re-placement at 4, 8, 12, 16, 20, and 24 weeks after filling 7) Incidence of diseases and adverse events 8) Number of days from bio-cocktail tissue filling to hospital discharge 9) Perianal Disease Activity Index (PDAI) *3 10) van Assche MRI score Footnotes: *1: Defined as cessation of purulent discharge even with gentle finger pressure. *2: Defined as the absence of abscesses larger than 2 cm on MRI. *3: Evaluated as a reference value in subjects without Crohn's disease. | — |
Contacts
Public ContactDaichi kitaguchi
University of Tsukuba Hospital
Outcome results
None listed