Health Condition 1: K605- Anorectal fistula
Conditions
Interventions
Intervention1: Stempeucel®: The patients will receive Stempeucel® 75 million cells (15 mL containing 5x106 cells/mL) by intralesional injection. Stempeucel® will be supplied in three vials of 25 mi
Sponsors
All India Institute of Medical Sciences
Stempeutics Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. A signed and dated informed consent form and audio visual consent has been obtained from the patient. 2. Patient is able and willing to comply with study procedures 3. Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 years. 4. Diagnosed with a complex perianal fistula associated with Crohnâ??s Disease of at least 3 months before screening visit with a maximum of 1 internal openings and a maximum of 2 external openings. 5. Actively draining fistulas. 6. Patients whose perianal fistula were previously treated and are refractory to medical therapy (antibiotics for 1 month or immunomodulators for 3 months or on biological therapy (TNF â?? ? antagonist) or surgical therapy and has shown or have documented intolerance. Note: Definition of complex fistula: Complex fistulae are high (high inter-sphincteric, high intra-sphincteric, suprasphincteric or extra-sphincteric) and/or can have several external openings, may be associated with a perianal abscess, connection to the vagina or bladder, rectal stenosis or macroscopic proctitis.
Exclusion criteria
Exclusion criteria: 1. Crohnâ??s Disease Activity Index (CDAI) score ? 220. 2. Perianal abscess > 2 cm in diameter. 3. Presence of proctitis, anal canal stricture and fistulas other than perianal fistulas. 4. Received steroids within 1 month prior to enrolment or who has not received any treatment for perianal fistulas. 5. Presence of other autoimmune diseases, active tuberculosis. 6. Patients allergic to bovine serum. 7. Patient with known hypersensitivity to the constituents of the IMP â?? DMSO, Dextran 40, CryoStor® - CS5. 8. Pregnant and lactating women. 9. Patients already enrolled in another investigational drug trial or completed within 3 months or those who have participated in any stem cell clinical trial any time in the past. 10. Patient has a current or past history of any cancer. 11. Patients with Hb 12. Patientâ??s serum bilirubin level 2 times more than upper normal limit. 13. Patient has any of the following unstable conditions or circumstances that could interfere with the standard care of treatment: • Inability to comply with treatment visit schedule • Mental incapacity • Current substance abuse 14. Positive for HIV, HCV, HBV, VDRL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s) Assessment of clinical laboratory parameters Physical examination findings and assessment of vital signs Assessment of electrocardiogram (ECG) parametersTimepoint: 24 weeks and 104 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the Perianal Disease Activity Index (PDAI). Change in IBD control quality of life questionnaire scores Change in Crohnâ??s Disease Activity Index (CDAI) Change in MRI scores (Van Assche index) Time to remission Time to response Time to relapse Timepoint: 24 weeks and 104 weeks | — |
Countries
India
Contacts
Public ContactJijy Abraham
Stempeutics Research Pvt Ltd
Outcome results
None listed