Regenerative Medicine / Stem Cell Trials

Clinical trials for the specialty

  • Sponsor: Private Foundation

    IACUC protocol#: G2015-58                                                                                                                                 Status:  Currently enrolling

    Description:

    The goal of this study is to compare plasma biomarkers in the form of extracellular RNA in dogs with mitral valve disease presenting with versus without congestive heart failure.

    This study will be an important step towards making exosome analysis a useful and readily available tool for evaluating the progression, the molecular basis for remodeling, and development of specific therapies for mitral valve disease.

    Inclusion/exclusion criteria:

    All dogs should be over eight years of age in order to control for age related differences.

    Healthy: for controls the dogs will be defined as a healthy animal with a normal physical exam, normal CBC/chemistry panel/UA and no evidence of a heart murmur as documented by a veterinarian

    There will be four populations that will be included in this study:

    • Group 1: Healthy dogs with no cardiac disease
    • Group 2: Dogs with mitral valve disease not in congestive heart failure.
    • Group 3: Dogs with mitral valve disease in congestive heart failure.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

  • CSRC protocol # 115.16

    Status: Currently enrolling

    Description:

    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 diseaseSpecifically, 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

    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 present with partial or complete relapse from cyclosporine A therapy.

    Exclusion Criteria:

    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.

    Client Benefits:

    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.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu