CSRC protocol # 115.16
Status: Currently enrolling
The goal of this study is determine if a human stem cell-based therapy can be used to treat perianal fistulas, a condition that occurs in dogs but also occurs in some humans suffering from Crohn’s Disease. The current treatments (steroids and cyclosporine) are ineffective in a high percentage of patients and the disease relapses frequently. Also, cyclosporine is very expensive and has many side effects. We want to investigate if human stem cells (hESC-MSCs) injected in the fistulas can induce remission of the disease. Specifically, we would like to determine if a second injection of hESC-MSCs can close any fistulas that may re-appear after the initial closure of fistulas (ie, if the effects of the first injection wear off). The hESC-MSC can have some advantage compared with autologous stem cells, for instance, namely: (1) ease of use (no need to extract bone marrow, high numbers easily generated in the lab); (2) well defined and constant property (no variability) (3) higher anti-inflammatory properties. The trial is therefore of high interest not only for this specific disease but also for other diseases that may benefit from treatment with hESC-MSCs in humans.
This trial is also being conducted at Massachusetts Veterinary Referral Hospital in Woburn, MA
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 present with partial or complete relapse from cyclosporine A therapy.
Dogs younger than 1 year or older than 12 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.
Once enrolled, all costs associated with this study (e.g., cyclosporine, sedation medication, stem cell treatment, check-ups, blood draws) will be covered for the duration of the follow-up period (i.e., for 6 months after the last MSC injection). Treatment related complications (such as localized infection, allergic reaction) will be covered up to $1000 by the sponsor. Costs incurred due to unrelated complications will not be covered. Your pet’s participation will also allow us to gain information which will help in the diagnosis of other dogs with this condition. You understand that your animal’s participation in this study may not alleviate or cure his/her ailment.
For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: email@example.com