Regenerative Medicine / Stem Cell Trials

Clinical trials for the specialty

  • Sponsor: Private Foundation

    CSRC Protocol #: 007.15

    Status:  Fully enrolled

    Description:

    The goal of this study is to develop a new treatment for perianal fistulas in dogs.  The current treatments for this severe condition (steroids and cyclosporine) are ineffective in a high percentage of patients and the disease relapses frequently.  Also, cyclosporine is expensive and has many side effects, so a major goal is to develop a therapy which reduces the need for immunosuppressive agents, such as cyclosporine. Previous trials using intralesional injections of stem cells have shown very encouraging results.

    Inclusion Criteria:                               

    • Adult dogs, any breed and either gender, 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
    • Age range 1-12 years
    • Weight range 2-100 kg

     

    Exclusion Criteria:

    • Dogs younger than 1 year or older than 12 years
    • Other severe diseases ( severe osteoarthritis, cardiac disease, neoplasia, skin disease)
    • Dogs that have had surgery (cryosurgery, anal sac resection, tail amputation) to treat the anal fistulas

     

    Client Benefits:

    The study will cover all the costs of the examinations (once your dog is found eligible) and stem cell treatments including sedation.  The study will provide $300 to participants toward purchase of cyclosporine during the 1 year study.

    Contact information:

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

  • 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

     

  • Status:  Currently enrolling

    Description:

    The success of cardiopulmonary resuscitation (CPR) is very low, in veterinary (as well as human) patients. Even after successful return to spontaneous circulation, sequela to CPR include repeated cardiac arrest, brain disease, and multi-organ system failure. Low oxygen levels to the brain is the major factor contributing to these poor outcomes. There is a critical gap in our understanding of the physiology and prognosis after CPR, which has led to failure to substantially improve our success in dealing with this problem.

    An important goal of this study is to understand how chemicals called nucleic acids (RNA) are altered in post-CPR canine patients. The study will focus on very small RNA (miRNA). The specific objective of this study is to understand which miRNA are released into the circulation of canine patients after cardiopulmonary resuscitation (CPR) versus non-CPR patients hospitalized in the ICU for other reasons.

    There is tremendous potential value in identifying circulating miRNA after CPR. First, miRNA may assist in predicting outcome (prognosticating) in individual patients in the future. Second, miRNAreleased into the circulation are indicators of major epigenetic disturbances as a consequence of hypoxia-ischemia.    Knowledge of these miRNA may lead to the design of novel therapies to counteract these effects, for example employing stem cells that release mitigating miRNA.

    Inclusion Criteria:

    Group 1:  Six dogs that have undergone CPR according to standard protocols in the TCSVM emergency room and have returned to spontaneous circulation for a minimum of 1 hr.

    Group 2:  Six dogs hospitalized in the ICU that have not experienced CPR or significant hypoxemia or ischemia (e.g. GDV, hemorrhage, stroke) will be selected for sampling at the same time (AM vs. PM). Dogs will be similar age and gender as post-CPR patient.

    Any breed is acceptable.

    Exclusion Criteria:

    • Dogs < 10 kg
    • Dogs with prior hypoxemia insult (prior arrest or CPR, GDV, stroke, hemorrhagic shock, congestive heart failure, etc).
    • Dogs with a diagnosis of cancer
    • Dogs with hemolytic disease
    • Dogs for which blood sampling is contraindicated (recent fluid/colloid resuscitation)

     

    Client Benefits:

    The study will cover the cost of a blood panel (NOVA) at the same time the sample is being collected; this is testing that is normally performed every few hours during recovery from CPR, it is also testing that is normally performed in sick dogs. Your pet’s participation will also allow us to gain information which will help in the treatment 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

     

  • Sponsor: Private Foundation

    CSRC Protocol #: 117.15

    Enrollment: Currently enrolling

    Description:

    Dogs presenting with acute, concussive disk herniations share many similarities with human spinal cord injury patients. The prognosis for return to normal function is very guarded in dogs with acute onset of paraplegia and loss of pain perception in hind legs. The likelihood to regain ambulatory status is within the range of 43-69%. Fecal incontinence was observed in 41% and urinary incontinence in 32% of dogs regaining pain perception and ambulatory function. In dogs which fail to regain pain perception and ambulatory function after surgery, fecal and urinary incontinence will persist and frequent urinary tract infections are common. In addition, in some dogs this dysfunction can progress to the level of ascending urinary tract infection and sepsis.    New therapies are needed to improve these outcome.

    We propose to transplant allogeneic Wharton’s Jelly (umbilical cord matrix) mesenchymal stem cells (WJ-MSC) into the spinal cord of dogs admitted to the Foster Hospital at Cummings Veterinary Medical Center at Tufts University because of severe spinal cord injury secondary to intervertebral disc herniation/compression in order to study their potential as neuroprotective and regenerative agents.

    Our hypothesis is that chondrodystrophic dogs with an acute onset of paraplegia and loss of pain perception caudal to a thoracolumbar disk extrusion treated with decompressive surgery and subdural allogeneic WJ-MSC will have a significantly higher likelihood of a functional recovery than dogs treated with decompressive surgery alone.

    In this prospective study, paraplegic dogs with absent pain perception will be randomly assigned to WJ-MSC (in Cryostor) plus surgery or vehicle (Cryostor) plus surgery. Parameters of interest include time to return of pain perception, motor function, ambulation and urinary/fecal continence. A successful outcome will be defined as return to ambulatory function, normal pain perception caudal to the lesion and full urinary and fecal continence within 3 months post-surgery.

    A positive functional outcome as a result of stem cell transplantation would be a tremendous benefit and step forward for dogs being affected with concussive disk herniations. Determining such efficacy, along with an assessment of any related complications, would provide an ideal naturally occurring disease model in dogs could also be utilized in human therapeutics of spinal cord injury.

    Inclusion Criteria:

    Dogs of any age, sex weighing less than 25 kg with the following:

    ° Complete medical history

    ° Owner consent for inclusion into study

    ° Paraplegia with absent pain perception in hind legs and tail at admission

    ° Extradural compression between T3 – L3 diagnosed with CT or MRI

    ° Acute disk extrusion confirmed at surgery

    ° Follow up performed at Cummings School of Veterinary Medicine at Tufts University by neurology service

    Exclusion criteria:

    ° Unable to confirm disk extrusion intraoperatively

    ° Concurrent disease that could interfere with neurologic recovery

    ° Inability to obtain in-hospital follow-up performed at Tufts University by the neurology service

    ° No owner consent

    Client benefits:

    The study will cover all of the costs of stem cells treatment and follow-up appointments up to 3 months after the surgery, as well as contribute $1100 towards the cost of surgery. Your pet’s participation will also allow us to gain information which will help in the diagnosis/management/treatment 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

     

  • Status: Currently enrolling

    Description:

    The goal of this study is to measure the presence of a blood marker, miRNA, in dogs with naturally occurring bone cancer (osteosarcoma) and compare these results to healthy unaffected dogs. We hypothesize that the presence of this biomarker will positively correlate with the presence of tumor and high expression levels may be associated with outcomes of disease-free interval and survival time in dogs with osteosarcoma.  Approximately 10 mls (2 teaspoons) of blood will be collected from your dog’s vein via routine blood sampling. Blood collection ideally will occur both prior to and following removal of your dog’s tumor. This is a safe amount of blood that can be sampled in any dog greater than 5 kilograms.

    Inclusion Criteria:

    Dogs with osteosarcoma weighing 5 kilograms (11 pounds) or greater

    Client Benefits:

    Your pet’s participation will allow us to gain information, which will help in the diagnosis/management/treatment 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

     

  • Sponsor: Private foundation

    IACUC Protocol # G2016-125

    Status: Currently enrolling

    Description:

    This study has two components;

    1. To examine blood from dogs with skin diseases (including atopic dermatitis, pemphigus foliaceus and perianal fistulas) compared with blood from healthy dogs to identify factors (‘biomarkers’) that may play a role in the disease process.
    2. To develop a blood test for the skin disease (pemphigus foliaceus, or ‘PF’).

    It is hoped this study will enable us to gain a deeper understanding of disease processes with the long term goal of finding alternate approaches to diagnose, monitor, prevent or treat these chronic skin diseases.

    Inclusion Criteria:

    Blood samples from dogs presenting to the Tufts dermatology service with skin diseases (atopic dermatitis, pemphigus foliaceus and perianal fistulas) and healthy control dogs are required for this study as we are investigating features of naturally occurring skin diseases in the general canine population and comparing this to blood from healthy dogs to identify factors that contribute to the diseased state

    Exclusion Criteria:

    Dogs weighing less than 5kg, dogs less than a year old or greater than 14 years old, pregnant dogs.

    Dogs will be excluded from the healthy control group if they have evidence of skin disease on physical examination or from their history, or if they have evidence of systemic disease (other than age appropriate changes) on their history, physical examination or bloodwork.

    Client Benefits:

    There are no additional costs to you for taking the blood sample. The study will cover the cost of a complete blood count/serum biochemistry health screen panel run on your dog’s blood on the first sample only, and these results will be provided to you.

    Costs for any diagnostics or treatment recommended by your veterinarian resulting from abnormal findings on the blood test or relating to their skin disease are not provided by this study.

    Your animal’s participation in this study does not influence ongoing management or treatment of any medical condition by your veterinarian, and will not change any treatment or outcome for his/her skin disease.

    Contact Information:

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

     

     

  • Sponsor: Private Foundation

    IACUC Protocol # G2016-134

    Status:  Enrollment currently on hold

    Description:

    Dogs develop inflammatory bowel disease (IBD) spontaneously, which results in persistent or recurring signs such as weight loss, vomiting, and/or diarrhea, and is characterized by inflammatory cell infiltration in the intestine.

    In both humans and dogs, IBD is considered to be an idiopathic, chronic, relapsing immune-mediated inflammatory disorder of the GI tract that involves the interplay between genes, diet, and the microbes in the intestine. The treatment for IBD in both dogs and humans is similar, and relies on diet, immune suppression.

    The goals of this experiment are: 1) to evaluate the gene expression of the white blood cells in the intestine and the blood of dogs with inflammatory bowel disease compared to normal dogs, and 2) to evaluate the in vitro response to activation of the T cells in the blood and intestine of dogs with IBD and normal dogs, and 3) to determine in vitro if extracellular vesicles (EV) derived from canine mesenchymal stem cells (MSC) or the MSC themselves are able to reduce the inflammation seen in dogs with IBD.

    MSC are cells derived from the tissue around the umbilical cord, which are known to have anti-inflammatory and regenerative properties. EV are nanoparticles released from the MSC, which contain many signaling molecules that are also potentially capable of anti-inflammatory properties.

    Inclusion Criteria:

    IBD group:

    Dogs over 1 year of age and weighing > 5 kg undergoing upper gastrointestinal endoscopy for evaluation of a history of chronic gastrointestinal signs of at least 3 weeks duration (vomiting, diarrhea, and/or weight loss) will be considered. These dogs will have no identifiable cause for their clinical signs on routine diagnostic evaluation (complete blood count, serum chemistry, urinalysis, baseline cortisol). Dogs will need to have had a veterinarian-recommended diet trial for at least 1 week with incomplete resolution of signs, as well as be incompletely responsive to an antibiotic trial with metronidazole or tylosin. Eligible dogs will have had a negative fecal floatation and Giardia ELISA or negative zinc sulfate floatation, or be non-responsive to a treatment course with fenbendazole (50 mg/kg daily for 3 days).

    Control dogs for blood and GI tissue acquisition will include otherwise healthy dogs undergoing endoscopy for foreign body retrieval and weighing > 5 kg. Dogs will have no evidence of systemic disease (change in weight, thirst, urination, activity level), and no history of gastrointestinal signs unrelated to recent foreign body ingestion.

    Exclusion Criteria:

    Dogs with cancer detected on physical examination or diagnostics performed will be excluded. Dogs cannot be on topical or oral short acting steroid therapy (prednisone or prednisolone), other oral immunosuppressants (i.e., azathioprine, cyclosporine), or oral non-steroidal anti-inflammatory (i.e., Rimadyl, Deramaxx) medication for at least 1 week prior to biopsy. Antibiotic therapy will not exclude a patient from enrollment.

    Client Benefits:

    Fees associated with histopathology (microscopic evaluation of the intestinal tissue) performed during the study will be covered during your participation in the study. Costs incurred by additional anesthesia time over that needed for diagnostic biopsy collection or foreign body removal will be covered by the study.

    In the event any complications arise during endoscopy, their management will be covered by you.

    Contact Information:

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