Anal or recto-cutaneous or recto-vaginal Crohn-related fistula MedDRA version: 20.0 Level: PT Classification code 10002156 Term: Anal fistula System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: Auto-ASC
Product Code: Auto-ASC
Pharmaceutical Form: Dispersion for injection
INN or Proposed INN: auto-ASC
Current Sponsor code: auto-ASC
Other descriptive name: Autologous adipose tiss
Sponsors
Jagiellonian University - Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Expressing informed consent to participate in the study and consent to the collection of adipose tissue. 2. Gender: female, male. 3. Age> 18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Lack of consent to participate in a clinical trial. 2. A fistula of a different etiology than Crohn's disease (eg discrete). 3. Coexisting mental disorders. 4. Limited contact making it impossible to understand and accept the test conditions, 5. Pregnancy, puerperium and breastfeeding 6. BMI <18 or no subcutaneous, abdominal fat, 7. HIV, HBV, HCV, HTLV, syphilis, or other infections that contraindicate living donation. 8. Infectious diseases involving the perineal region, 9. Active neoplastic disease or condition after treatment of malignant neoplasms (withdrawal period: 5 years from the end of treatment). 10. Immunosuppression within 4 weeks prior to screening visit. 11. Autoimmune diseases or infections (hepatitis B, hepatitis C, HIV, syphilis). 12. Failure of at least one organ (heart, liver, kidney, lung) with a statistically predicted life span <2 years, 13. Participation in any other clinical trial or therapeutic experiment (withdrawal period not shorter than 60 days). 14. Claustrophobia or other factors that prevent MRI, 15. Developmental disorders of the large intestine preventing rectoscopy, 16. Status after radiotherapy of the minor or major pelvis or the abdominal cavity. 17. Sensitization to the ingredients of the investigational medicinal product or gadolinium (MRI cannot be performed).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The evaluation of the clinical efficacy of recto-cutaneous and recto-vaginal Crohn-related fistulas treated by auto- or allogeneic mesenchymal stem / stromal cells in comparison to placebo. 1. Percentage of healed fistulas at months 3 and 6 after intervention (I2) in the ASC groups (auto- and allogeneic) in relation to the placebo group. 2. Percentage of healed fistulas at month 12 (late healing) from intervention (I2) in the ASC groups (auto- and allogeneic) compared to the placebo group. 3. The rate of remission (resolution of active fistula symptoms) at months 3 and 6 after intervention (I2) in the ASC groups (auto- and allogeneic) compared to the placebo group. 4. Rate of remission (resolution of active fistula symptoms) at month 12 after intervention (I2) in the ASC groups (auto- and allogeneic) compared to the placebo group. 5. Relapse rate at month 12 after intervention (I2) in the ASC groups (auto- and allogeneic) compared to the placebo group.;Secondary Objective: Safety evaluation of auto-ASC and allo-ASC in comparison to the placebo group.;Primary end point(s): 1. Percentage of healed fistulas at months 3 and 6 after intervention (I2) in the ASC groups (auto- and allogeneic) in relation to the placebo group. 2. Percentage of healed fistulas at month 12 (late healing) from intervention (I2) in the ASC groups (auto- and allogeneic) compared to the placebo group. 3. The rate of remission (resolution of active fistula symptoms) at months 3 and 6 after intervention (I2) in the ASC groups (auto- and allogeneic) compared to the placebo group. 4. Rate of remission (resolution of active fistula symptoms) at month 12 after intervention (I2) in the ASC groups (auto- and allogeneic) compared to the placebo group. 5. Relapse rate at month 12 after intervention (I2) in the ASC groups (auto- and allogeneic) compared to the placebo group.;Timepoint(s) of evaluation of this end point: 3, 6 and 12 months from the date of the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The type and frequency of reactions and adverse events in the intervention groups in relation to the control group assessed during the study and at the last visit.;Timepoint(s) of evaluation of this end point: 3, 6 and 12 months from the date of the intervention | — |
Countries
Poland
Contacts
Public ContactBiuro ds. Badan Klinicznych
Jagiellonian University - Medical College
Outcome results
None listed