Protocol identification: CSRC 030-13, approved 10/15/13
Sponsor: Advanced Cell Technology, Marlborough, MA
Principal Investigator: Lluis Ferrer DVM, PhD, DECVD (Dermatology)
Contact information: firstname.lastname@example.org, (508) 839-5395, ext 84419
Status of trial: Enrollment start date: Jan 27, 2014
Inclusion criteria: Adult dogs (either gender, any breed) with a clinical diagnosis of anal fistulas (presence of chronic peri-anal fistula(s) with clinical signs of tenesmus, dyschezia) and history of failure to respond completely to cyclosporine A therapy.
Exclusion criteria: Dogs younger than 1 year or older than 10 years will be excluded; dogs with other severe diseases (severe osteoarthritis, cardiac disease, neoplasia, skin diseases) apart from anal furunculosis will be excluded. Dogs that had surgery (cryosurgery, anal sac resection, tail amputation) to treat the anal fistulas will not be included.
Arms/interventions: This is a single arm open-label pilot study (n=6). Dogs will receive hES-MSCs injected intra-lesionally (distributed evenly between fistulas) and covered by an FDA approved fibrin sealant (Evicel). Dogs will be maintained on cyclosporine A at the same dose for the first 60 days after injection of the hES-MSCs, and then withdrawn for as long as they remain in clinical remission.
Potential direct or indirect benefits from the study: The study will cover all of the costs of this study including initial examination, stem cell treatment, ~$300 towards Cyclosporine treatment, and recheck examinations at 1, 2, 3, and 6 mos after injection of MSCs.
- Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees: Ms. Dawn Meola (email@example.com, 508 887 4589).
- To reach the Principal Investigator, see contact information listed above.
- For all other questions concerning clinical trials, please contact Dr. Andrew Hoffman (Director, Regenerative Medicine Laboratory) at firstname.lastname@example.org.