Dogs

Clinical trials for dogs

  • Description

    The goal of this study is to determine if TK isoenzymes are good biomarkers for the early detection of HSA in dogs and to identify a threshold for detecting HSA from the presence of TK isoenzymes.

    HSA is a malignant and rapidly growing cancer that is difficult to detect. HSA is a tumor derived from blood vessels, and thus the tumor is filled with blood. A frequent cause of death from HSA is the rupturing of the tumor, causing the patient to rapidly hemorrhage to death. HSA is common in dogs, and more so in certain breeds of dogs such as German Shepherds and Golden Retrievers. Dogs with HSA rarely show clinical signs until the tumor has become very large and has metastasized. Typically, clinical signs are due to hypovolemia after the tumor ruptures, causing severe bleeding. Owners of the affected dogs often discover that the dog has HSA only after the animal has collapsed secondary to bleeding. The HSA tumor often appears on the spleen, right side of the heart or liver.

    There are currently no commercially viable screening mechanisms for detecting HSA in dogs. Most dogs present with HSA as emergencies and major decisions about treatment must be made without a definitive diagnosis. A screening test that would allow the detection of HSA would be very valuable in the planning of treatment and earlier detection of the disease. Preliminary data in dogs suggests that TK is significantly increased in dogs with some types of cancer, specifically HSA and thus TK may be useful in detecting, staging and monitoring disease in dogs with HSA.

    Inclusion Criteria

    Any dog (any age, sex or breed) with a hemoabdomen that undergoes exploratory surgery.

    Exclusion Criteria

    Dogs with pre-existing, previously diagnosed neoplastic conditions other than hemangiosarcoma will be excluded.

    Client Benefits

    There are no direct benefits to the client. The indirect benefit is that this research will aid in the development of a point-of-care test for the diagnosis of hemangiosarcoma in dogs which will help owners of dogs with hemoabdomen make decisions regarding the best management for their dogs.

    Contact Information

    Dr. Claire Sharp
    Phone: (508) 839-5302

  • Description

    To determine whether administration of beta-blockers results in either a prolonged survival or a longer time until recurrence of pericardial effusion in dogs with hemangiosarcoma.

    Inclusion Criteria

    Dogs with pericardial effusion and a right atrial mass identified on echocardiogram are eligible for the study.

    Exclusion Criteria

    Dogs with certain severe irregular heart rhythms (e.g., ventricular tachycardia) and dogs who have surgery for the condition.

    Client Benefits

    The results of this study will help us determine whether treatment with beta-blockers improves the outcome in dogs with this disease. The cost of the recheck echocardiogram is covered by the study.

    Contact Information

    Dr. John Rush
    Phone: (508) 839-5395, ext. 8-4696.

  • Description

    To evaluate the effect of plavix dosing in respect to how much time is needed to achieve maximum platelet inhibition which may decrease risk of thrombeombolic disease.

    Inclusion Criteria

    Diagnosis of protein losing nephropathy, cases with high indices of suspicion without definitive diagnosis will also be considered.

    Exclusion Criteria

    Dogs will be excluded if they have received steroids or any anticoagulant medications.

    Client Benefits

    May be able to use a lower dose of plavix, therefore, more cost-effective.

    Contact Information

    Dr. Melissa Bucknoff, DVM
    Phonoe: (508) 839-5395

  • Description

    To evaluate the utility of MRS in non-invasively differentiating brain tumor types in dogs. MRS is an additional imaging study that can be done in conjunction with the MRI. The study includes any additional fees incurred for anesthesia and imaging for the MRS imaging only. It does not include fees for the MRI or the anesthesia required for the MRI.

    Inclusion Criteria

    Dogs with MRI findings consistent with a brain tumor. The study will include 24 dogs.

    Exclusion Criteria

    Unstable patients who would be at increased risk with a longer anesthesia time are excluded from the study.

    Client Benefits

    Preliminary results have shown differences in gliomas and meningiomas as compared to normal dogs. MRS is also non-invasive, therefore there are no additional risks for the patient.

    Contact Information

    Dr. Katie Weiss, DVM
    Phone: (508) 887-4696

  • Description

    Weight loss is one of the few factors that have consistently been shown to be associated with shortened survival in people with lymphoma. This study aims to document how often dogs experience weight loss or decrease in muscle mass at the time that lymphoma is diagnosed, and whether this finding impacts how dogs respond to treatment.

    Inclusion Criteria

    Dogs with multicentric lymphoma that have undergone full staging.

    Exclusion Criteria

    Prior chemotherapy (including prednisone) or dogs with lymphoma within the gastrointestinal tract.

    Client Benefits

    None

    Contact Information

    Kelly Reed, Oncology Liaison
    Phone: (508) 887-4682

  • Description

    The Cummings School of Veterinary Medicine at Tufts University was selected as a contributing site for theCCOGC Biospecimen Repository. This is an innovative multi-institutional endeavor organized by researchers at the NCI to create a large tissue repository of spontaneous canine cancers.

    The tissues within these repositories will be used for future investigations by researchers at locations across the country to allow a better understanding of canine and human cancers.

    Inclusion Criteria

    Any dog that will be undergoing a surgical procedure as part of his/her treatment. At the time of surgery, the tumor is sent to the pathology laboratory for diagnosis or examination. When these tests are completed, the remainder of the tissue is usually discarded. We would like to acquire any left over tissue to use for archiving purposes.

    Exclusion Criteria

    None.

    Client Benefits

    There is no direct benefit for participating in the tissue collection and banking. However your participation may help in understanding the genetic basis for canine (and possibly human) cancers.

    Contact Information

    Kristin Marshall, Oncology Clinical Trials Coordinator
    Phone: (508) 887-4422

  • Description

    The main goals of this study are to correlate the different histologic subtypes of canine lymphoma with gene expression and response to treatment and survival time.

    Inclusion Criteria

    All dogs with newly diagnosed multicentric lymphoma that have enlarged peripheral lymph nodes are eligible for entry into this study.

    Exclusion Criteria

    Patients that have received prior chemotherapy are not eligible for participation in this study.

    Client Benefits

    The owner is financially responsible for all tests that determine if the patient qualifies for the study. These tests may include initial specialty examination, blood and urine tests.

    The study will cover the costs of blood collection and histopathologic evaluation, including immunophenotype of your dog’s lymph node tissue (if applicable).

    Contact Information

    Kelly Reed, Oncology Liaison
    Phone: (508) 887-4682

  • Description

    Osteosarcoma is the most common primary bone tumor in dogs. Despite aggressive treatment with surgery and chemotherapy, most dogs die of metastatic disease that is resistant to conventional chemotherapy. Metronomic chemotherapy entails very small doses of chemotherapy that are given daily or every other day and help to deter the growth of new blood vessels needed to nourish cancer as it grows. Side effects associated with metronomic chemotherapy tend to be milder and less frequent than those seen with standard chemotherapy. The goal of this study is to evaluate for an increased disease free interval in dogs treated with standard of care surgery and chemotherapy followed with maintenance metronomic or low dose chemotherapy.

    Inclusion Criteria

    Dogs with osteosarcoma that have completed a standard course of chemotherapy after limb amputation.

    Exclusion Criteria

    Dogs with a life expectancy of less than 1 month or who have lower urinary tract disease are ineligible to participate in this study.

    Client Benefits

    This study is not funded; so pet owners are responsible for all costs associated with this treatment.

    Contact Information

    Kelly Reed, Oncology Liaison
    Phone: (508) 887-4682

  • Description

    This preclinical trial, sponsored by the National Cancer Institute, is designed to evaluate three new chemotherapy agents in the indenoisoquinoline class. These drugs inhibit topoisomerase I, which is an enzyme important in DNA replication, and have shown efficacy in a variety of cancers.
    The intent of this study is to define and compare the pharmacologic effects of these three drugs in dogs with lymphoma. Specifically, the study will assess basic properties of the drug, such as duration of action, markers of damage to DNA in cancer cells, and safety. The goal is to determine the appropriate dose of each drug and to determine if there are differences in biologic activity among the drugs. The response to treatment, specifically whether lymphoma goes into remission in the treated dogs, will also be assessed.

    Inclusion Criteria

    • Dogs of any age
    • Cytologically or histologically confirmed diagnosis of lymphoma involving multiple external lymph nodes
    • Dogs must be feeling well or only minimally compromised
    • Dogs either must not have received treatment for lymphoma for at least 2 weeks prior to enrollment in the study

    Exclusion Criteria

    • Significant illness (such as kidney failure, liver disease, heart failure, severe anemia)
    • Dogs weighing less than 33 pounds
    • Dogs who have received prednisone for any reason in the two weeks prior to study enrollment

    Client Benefits

    This study is fully funded and will cover the cost of treatment, monitoring tests and management of treatment related side effects. Dogs that complete the 28-day study will be eligible to receive $1000 for further medical care at Tufts.

    Contact Information

    Kelly Reed, Oncology Liaison
    Phone: (508) 887-4682
    Email: Veterinaryoncology@tufts.edu

  • Description:

    Lymphoma is one of the most common cancers in the dog and is comparable to non-Hodgkin’s lymphoma in humans. Chemotherapy is the standard of care for treatment and can provide long term disease control but survival beyond 2 years is rare.

    There is active investigation into the utility of metabolic markers, such as insulin-like growth factor 1 (IGF-1), as a predictor of response to treatment in humans with non-Hodgkin’s lymphoma. Additionally these markers may serve as a target for future therapy.

    The goal of this study is to assess levels of IGF-1 and other related blood biomarkers in canine patients with lymphoma. We will evaluate these markers for prognostic value and will determine whether they could serve as targets for therapy in the future.

    Inclusion Criteria:

    Dogs with a confirmed diagnosis of multicentric lymphoma (cytology or pathology), weighing more than 25kg. Dogs must be eating a commercial diet and be otherwise healthy.

    Exclusion Criteria:

    Dogs with other systemic diseases (diabetes mellitus, hypothyroidism, Cushing’s disease, kidney disease, liver disease, etc). Dogs eating a home-cooked or raw diet.

    Client Benefits:

    No direct benefits. Dog owners are financially responsible for the costs associated with cancer staging plus standard chemotherapy and recommended treatment monitoring (weekly complete blood counts).

    This study covers the cost of measurement of IGF-1 and other metabolites.

    Contact Information:

    Kelly Reed, Oncology liaison

    508-887-4682

     

     

     

     

  • Description:
    OA is a progressive degenerative disease with a variety of treatment options suggesting that reliable, safe, and effective treatment has yet to be discovered. In search of treatment options, autologous (dog’s own) concentrated platelets appear to show promise as a safe alternative, free of the risks associated with some non-steroidal antiinflammatory agents. The purpose of this study is to establish more data on the emerging C-PET treatment for OA.
    Inclusion criteria:
    Dogs must have a medical history or physical findings of bilateral elbow osteoarthritis.
    Must weigh at least 25 lbs.
    Must be between 18 months and 10 years of age.
    Exclusion criteria:
    Surgery on joint within one year
    systemic steroid administration,
    joint injection with in 4 months
    Adequan injection within one month
    Client benefits:
    The study will cover cost of blood work, radiographs, and C-PET treatment for qualified animals.
    Contact information:
    Jessica Schavone
    Clinical Trials Technician
    508.839.5395 x84441
  • Description
    The objective of this study is to evaluate whether quantitative MRI assessments after acute thoracolumbar disc extrusion are predictive of long term outcome through measurement of longitudinal dispersion of extruded disc material.
    Inclusion Criteria
    Only chondrodystrophic, nonambulatory paraparetic or paraplegic dogs with or without pain perception (<48 hours), an extradural spinal cord compression at T3 – L3 diagnosed by MRI, a disc extrusion confirmed at the time of the surgery and a detailed follow-up will be included.
    Exclusion Criteria
    Dogs with concurrent disorders incompatible with long-term survival will be excluded.
    Client Benefits
    Two week, 1 month and, if needed, 2 month and 3 month post operative recheck appointments will be paid for by the study.
    Contact Information
    Dr. Tracy Sutton Phone: (508) 887-4696
  • Description

    We have started a new study to evaluate the use of ultrasound as a quick and non-invasive method of measuring muscle mass in dogs.  In many of the common diseases of dogs, such as heart failure, kidney disease, and cancer, a big problem that occurs is muscle loss.  This muscle loss is important because it can make dogs weak and can negatively affect their quality of life.  We have been studying methods of diagnosing and treating cachexia (the muscle loss that occurs with various diseases) for over 15 years. We are currently evaluating whether ultrasound, an non-invasive test, can be used to quickly and easily diagnose muscle loss in its early stages. 

    Inclusion Criteria

    To be eligible, dogs must be healthy 1-5 year old, neutered dogs (male or female) of the following breeds:

    *Chihuahua

    *Dachshund

    *Cavalier King Charles Spaniel

    *Doberman pinscher

    *Boxer

     

    Dogs must be purebred and should have no heart murmur or other medical problems. 

    Exclusion Criteria

    Dogs with heart murmurs or any significant medical conditions

    Client Benefits

    If eligible, the dog will get a free examination at Tufts, will have a small blood sample collected (less than ½ teaspoon; to measure red blood cell count, blood sugar, and an estimate of kidney function), an x-ray of the chest to measure bone size, and an ultrasound of the muscles over his or her back (no shaving required). 

     

    In addition to getting the free tests (blood test, x-ray, and ultrasound of the back muscles), this information will be beneficial in the future for dogs with heart disease, kidney disease, cancer, and other common diseases by validating an easy ultrasound test to measure muscle mass. 

    Contact Information

    Dr. Lisa Freeman Phone: (508) 887-4696

  • Description

    The Tufts Obesity Clinic for Animals is conducting a new study to evaluate the effect of diet on how full dogs feel. Different nutrient profiles of diets may help some dogs feel fuller than others and we are using online surveys and in-person appointments to gather information on how owners feel their dog is full on different diets.

    Inclusion Criteria

    To be eligible, dogs must be healthy and overweight (Body Condition Score 6/9 or greater). Owners must be able to come to Tufts in North Grafton for 4 visits and fill out a brief survey online daily.
    Dogs should not be on medication (other than monthly preventatives) and should not have current medical problems.

    Exclusion Criteria

    Dogs with any significant medical conditions. Dogs eating any of the trial diets currently will also be excluded (this will be determined by diet history prior to the first appointment).

    Client Benefits

    If eligible, the dog will get 4 free appointments at Tufts with a board-certified veterinary nutritionist and will have a small blood sample and urine sample collected (to screen for any medical conditions including kidney or thyroid disease). Dogs enrolled in the study will be fed multiple diets throughout the study (including a transition period between diets), while owners rate how full their dogs feel in an online survey. In between diets, dogs will need to come in for their 4 recheck visits. At the completion of the study, owners will have the option to continue with a weight management plan with the Tufts Obesity Clinic for Animals and receive up to 4 free bags of a selected pet food.

    In addition to getting the free tests (blood test, urine test) and free food and weight guidance with a board-certified veterinary nutritionist, this information will be beneficial in the future to increase our success in weight management plans.

    Contact Information

    Dr. Deborah Linder: 508-887-4696
    Deborah.Linder@tufts.edu
    vet.tufts.edu/obesity

  • Description

    The goal of this study is to evaluate therapy with toceranib (Palladia®), an oral anticancer agent, in combination with palliative radiation therapy for tolerability, toxicity, and efficacy in a population of dogs with measurable carcinomas. Carcinomas are a common malignancy in both dogs and humans. As a category of cancer, carcinomas tend to be both locally invasive as well as carry a high risk of locoregional metastasis. While most dogs diagnosed in early stages may respond well to multimodality therapy, survival is generally thought to be shorter for bulky or metastatic tumors. New treatments for advanced carcinomas are needed to improve patient comfort and survival.

    Inclusion Criteria

    Dogs with cytologic or histology confirmation of the following carcinomas are eligible to participate in this study: anal sac adenocarcinoma, ceruminous gland carcinoma, mammary gland carcinoma, nasal carcinoma, prostatic carcinoma, salivary gland carcinoma, sebaceous adenocarcinoma, squamous cell carcinoma, rectal carcinoma, thyroid carcinoma, or transitional cell carcinoma of the urethra. The patient must have measurable disease at the primary tumor site and/or metastatic lymph nodes. Dogs should be otherwise in good health, a candidate for 10 daily anesthetic episodes, and must have adequate organ function as determined by blood work and urinalysis. Previous chemotherapy or surgery is allowable provided it is a minimum of 2 weeks prior to enrollment in the trial. Prior NSAID therapy is allowed if the patient has been on this therapy for minimum of 2 weeks prior to enrollment. Any homeopathic/alternative therapies for cancer must be discontinued prior to enrollment.

    Exclusion Criteria

    The following carcinomas are ineligible for participation: adrenocortical carcinoma, gastrointestinal carcinoma (excluding rectal), renal carcinoma, or transitional cell carcinoma of the urinary bladder. Dogs are also ineligible if they have received prior radiation therapy to the tumor site.

    Client Benefits

    Clients participating in this study will be given special financial considerations. Specifically, the study will cover the following costs associated with participation in this clinical trial: the cost of Palladia for 12 weeks, $1250 towards radiation therapy, one set of chest x-rays (at week 12), and recheck exam fees at week 3, 4, 6, and 12 of the study. This amounts to a total financial benefit of approximately $2200.

    The client will be responsible for general anesthesia and costs for the CT scan (if required); all radiation therapy costs beyond $1250; all costs associated with monitoring blood work and urinalyses during the study period and beyond; and any diagnostic tests (x-rays, abdominal ultrasound, etc.) and recheck exam fees beyond week 12. The client is expected to make and keep all appointments, according to the clinical trial protocol once enrolled.

    Contact Information

    Kelly Reed, Oncology Liaison
    Phone: (508) 887-4682

  • Protocol identification:  CSRC 004-13, approved 2/4/13
    Sponsor:  Advanced Cell Technology, Marlborough, MA
    Principal Investigator:  Mary Labato, DVM, DACVIM (Small Animal Internal Medicine)
    Contact information: mary.labato@tufts.edu, (508) 839-5395, ext ext 4825
    Status of trial:  not currently enrolling

    Inclusion criteria: Dogs presenting with protein-losing nephropathy, hypoalbuminemia (<2.4 g/dl), azotemia ( creatinine > 2.5 mg/dl), thrombocytopenia ( platelets < 160,000) and hypercoagulable state; renal biopsy confirmation of diagnosis of immune complex glomerulonephritis.

    Exclusion criteria: Dogs not expected to live greater than 48 hours, those with cardiac disease, and those with neoplasia. Also excluded will be those dogs with an active bacterial urinary tract infection, and those suspected or confirmed to have leptospirosis.

    Arms/interventions:  This is a single arm open-label pilot study.  All dogs (n=6) in this study will receive a single injection of hES-MSCs intravenously once eligibility criteria are met.  Standard of care will continue throughout the trial (90 days).

    Potential direct or indirect benefits from the study (for owners and RDVM): The study will cover all of the costs that are typically accrued in the diagnostic evaluation of dogs with protein-losing nephropathy including complete blood count, chemistry profile, urinalysis, urine culture, urine protein:creatinine ratio (UPC), thromboelastograph (a clotting profile), antithrombin level (to see if your dog is a risk for forming blood clots), ANA (looking for lupus) , serology for tick borne diseases and leptospirosis. It will also cover an abdominal ultrasound examination and the cost of a kidney biopsy.  The study will also cover for follow up blood work and urinalyses during the 90 days of the study, including 2, 7, 14, 30, and 90 days after treatment.

    Contact Information

    • Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees:  Ms. Dawn Meola (dawn.meola@tufts.edu, 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 andrew.hoffman@tufts.edu.
  • Protocol identification:  CSRC 006-13, approved 3/25/13

    Sponsor:  Advanced Cell Technology, Marlborough, MA
    Principal Investigator:  Cynthia Leveille-Webster, DVM, DACVIM (SA Internal Medicine)
    Contact information:  cynthia.leveille-webster@tufts.edu, (508) 839-5395, ext 84542
    Status of trial:  not currently enrolling

    Inclusion criteria:  Labrador Retrievers with histological diagnosis of moderate to severe chronic hepatitis (based on ‘Cornell hepatic scoring system’ which grades interface hepatitis, portal inflammation and lobular apoptosis/necrosis) and a serum ALT that is at least 3 times the upper limit of normal will be enrolled.

    Exclusion criteria:  presence of infectious disease (positive cultures of the liver or bile or positive titers for Leptosporosis), exposure to known hepatotoxic medications or supplements within the last month, the presence of extrahepatic bile duct disease (revealed by diagnostic imaging), severe co-morbidity (cardiac, renal or respiratory disease, evidence of end stage hepatic failure signified by the presence of large volume ascites, serum albumin less than 1.5 g/dl or clinical scores greater than 12), a histopathologic diagnosis of cancer and the presence of thromboembolic disease (splenic or portal vein thrombosis on ultrasound).  Evidence of SIRS or shock of any origin would exclude the patients.   Patients receiving corticosteroids within the last 2 months would be excluded.

    Arms / interventions:  This is a single arm open-label pilot study.  All dogs (n=6) in this study will receive a single intravenous injection of hES-MSCs once eligibility criteria are met.  Standard of care will be maintained throughout the trial with exception that dogs will not be able to receive corticosteroids or immunosuppressive agents for the first 42 days after injection of MSCs.

    Potential direct or indirect benefits from the study (for owners and RDVM):  The study will cover some of the costs.  Owners will be reimbursed for the expenses associated with the liver biopsy (including charges for the laparoscopic surgery and the charges for the pathologist to examine the slide) IF the biopsy is supportive of the diagnosis.  All of the expenses associated with giving the injection of stem cells and in evaluating your pet after the injection will be covered.  This will include CBC and serum chemistries at 1, 3, and 6 weeks and 3 and 6 months after stem cell injections.

    Contact Information

    • Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees:  Ms. Dawn Meola (dawn.meola@tufts.edu, 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 andrew.hoffman@tufts.edu.
  • 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:  lluis.ferrer@tufts.edu, (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.

    Contact Information

    • Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees:  Ms. Dawn Meola (dawn.meola@tufts.edu, 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 andrew.hoffman@tufts.edu.
  • Protocol identification:  CSRC 035-13, approved 10/25/13
    Sponsor:  Advanced Cell Technology, Marlborough, MA
    Principal Investigator:   Phil March, DVM, PhD, DACVN (Neurology).
    Contact information:  philip.march@tufts.edu, (508) 839-5395, ext 84953
    Status of trial:  Enrollment start date:  Jan 27, 2014.

    Inclusion criteria:  A clinical diagnosis of GME based on intracranial neurologic signs that are consistent with the typical neuro-anatomical distribution of GME; corroboration of clinical findings with MRI findings of multifocal lesions in regions of white matter; CSF findings typical of GME (total white blood cell count >50 cells per µl with a predominance of lymphocytes and monocytes/ macrophages); client consent to treat with MSCs as adjunctive therapy for GME.

    Exclusion criteria:   Dogs with necrotic or grey matter predominant forms of encephalitis (e.g. necrotizing meningoencephalitis).  Evidence of infectious disease on serology, PCR, or culture; significant pre-existing concurrent systemic illness (liver, renal, cardiac, etc.) based on routine clinical and laboratory testing (complete blood count, chemistry profile, and urinalysis); positive results of patient serum on the complement lysis assay (screen for patient auto-antibodies to human cells)

    Arms / Interventions:  This is a double arm, randomized controlled open-label study of adjunct effects of hES-MSCs added to standard of care.  Dogs (n=3/group) will be randomized to receive either (1) high dose corticosteroids (tapered over 8 wks) and intravenous hES-MSCs or (2) high dose corticosteroids (tapered over 8 wks) and procarbazine for 8 weeks followed by a single intravenous injection of hES-MSCs.

    Potential direct or indirect benefits from the study: The study will cover all costs associated with administering the hES-MSC treatment, all follow up hospital visits and exams (2, 4, 6, 8, 12, 16, 20, and 24 weeks post-treatment with hES-MSCs), all costs associated with biomarker analysis, and all costs associated with the follow up MRI at 8 weeks post-hES-MSC treatment.

    Contact Information

    • Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees:  Ms. Dawn Meola (dawn.meola@tufts.edu, 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 andrew.hoffman@tufts.edu.
  • Protocol identification:  CSRC 038-13, approved 10/9/13
    Sponsor:  Advanced Cell Technology, Marlborough, MA
    Principal Investigator:   Mike Kowaleski, DVM, DACVS / EVCS (Surgery)
    Contact information:  mike.kowaleski@tufts.edu, (508) 839-5395 ext 84659
    Status of trial:  Enrollment start date, Jan 27, 2014.

    Inclusion criteria:  Signalment:  15-10 kg; 10 months – 12 years of age; any gender.  Chronic, bilateral elbow osteoarthritis resulting in symptomatic forelimb lameness secondary to elbow osteoarthritis evident on clinical examination, confirmed radiographically with no clinical, hematological, or biochemical evidence of systemic disease.

    Exclusion criteria:   Systemic disease, other sources of musculoskeletal lameness (e.g. polyarthritis), reliance on daily oral NSAID or steroid therapy, aggression or behavioral disorders, exercise intolerance, recent (< 3 months) joint injections of non-cell or platelet derived products, or recent (< 6 months) elbow joint surgery.

    Arms / Interventions:   This is a single arm open-label pilot study of 6 patients.  The elbow joint of the lamer limb will be injected with hESC-MSCs.  The joint injections will be performed with standard sterile technique, under heavy sedation.

    Potential direct or indirect benefits from the study:   The study will cover all costs associated with screening candidates including radiographs and associated sedation.   The study will also cover the costs of administering the hES-MSC treatment and all follow up hospital visits and exams, including initial and 2, 4, 8, and 12 weeks.

    Contact Information

    • Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees:  Ms. Dawn Meola (dawn.meola@tufts.edu, 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 andrew.hoffman@tufts.edu.
  • Protocol identification:  CSRC 045-13, approved 11/19/13
    Sponsor:  Advanced Cell Technology, Marlborough, MA
    Principal Investigators:  Elizabeth Rozanski, DVM, DACVIM / DACVECC ext 84542, and Claire Sharp DVM, MS, DACVECC, ext 87934
    Contact information:  Elizabeth.rozanski@tufts.edu, (508) 839-5395, Ext 84745
    Status of trial:  Enrollment start date Jan 27, 2014.

    Inclusion Criteria:   Six dogs of either sex with a clinical diagnosis of abdominal sepsis due to GI perforation, whose owner has elected surgery, will be enrolled with owner consent. Diagnosis of abdominal sepsis is established by cytological evaluation of abdominocentesis fluid, confirming the presence of intracellular bacteria (e.g. bacteria visualized within neutrophils).   Abdominocentesis is clinically prompted by abdominal pain, fever, and effusion visualized on radiographs or by ultrasound.

    Exclusion criteria:  Dogs will be excluded from the study if they have GI perforation associated with neoplasia since this etiology is more likely associated with systemic disease, and potentially a worse outcome. GI neoplasia will be identified via abdominal ultrasonography confirming either a solitary GI mass, or enlarged abdominal lymph nodes and diffusely thickened intestinal loops consistent with GI lymphoma. Additionally, dogs will be excluded if they present in a moribund state and are not expected to survive initial stabilization and surgical exploration. Given the daily blood collection associated with this study we will exclude dogs weighing less than 5kg.

    Arms and interventions:   This is a single arm open-label pilot study.   Dogs in this study will receive intravenous hES-MSCs following gastrointestinal surgery and recovery from anesthesia.

    Potential direct or indirect benefits of participation:   The study will cover some of the costs of your dog’s care, including $500 towards the cost of surgery to repair the intestinal leakage, laboratory testing to monitor your pet’s progress.

    Contact Information

    • Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees:  Ms. Dawn Meola (dawn.meola@tufts.edu, 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 andrew.hoffman@tufts.edu.
  • Protocol identification: CSRC 043-13, approval pending clarifications.
    Sponsor: Advanced Cell Technology, Marlborough, MA
    Principal Investigator: Dominik Faissler, DVM, Diplomate ECVN (Neurology)
    PI contact information: dominik.faissler@tufts.edu, (508) 839-5395 ext 88758
    Status of trial: Anticipated enrollment start date: Jan 27, 2014.

    Inclusion criteria: Chondrodystrophic dogs, any sex, any age range, weight (5-20 kg bwt), paraplegia with absent pain perception in hind legs and tail at admission; extradural compression between T3-L3 diagnosed with myelogram, CT or MRI. Acute disk extrusion confirmed at surgery.

    Exclusion criteria: Unable to confirm intraoperative disk extrusion, concurrent disease that could interfere with neurologic recovery, inability to obtain in-hospital follow-up performed at Tufts University by the neurology service, or lack of owner consent.

    Arms / interventions: This is an single arm open-label pilot study. Dogs which quality will receive a single subdural injection of hES-MSCs at the time of hemi-laminectomy.

    Potential direct and indirect benefits from participation: The study will cover the costs of the stem cell therapy, and recheck examinations at 1, 3, 7, 14, and 42 days and 12 wks, and bloodwork at 7, 14, and 42 days and 12 weeks after hES-MSC treatment.

  • Description:

    Cancer is one of the most common conditions seen in older dogs and it is becoming more common for owners to opt to treat their pets with chemotherapy.  Dogs undergoing chemotherapy may suffer from side effects of treatment such as vomiting, diarrhea, and reduced appetite.  There are currently no commercial diets that are designed specifically to help support dogs with cancer undergoing chemotherapy by reducing the gastrointestinal side effects of chemotherapy.

    The purpose of the study is to determine whether a specially formulated diet may reduce gastrointestinal side effects associated with chemotherapy and improve quality of life of dogs undergoing chemotherapy.

    Inclusion Criteria:

    • Dogs > 1 year of age with multicentric lymphoma (LSA) and grade 2 or higher mast cell tumors (MCT) that will be treated with standard (non-metronomic) chemotherapy protocols at a participating study site.
    • Weight > 5 kg, temperament suitable for drawing blood without sedation
    • All dogs should be naïve to treatment for the current cancer, but can have been treated for other cancers in the past if greater than 1 year prior.

    Exclusion Criteria:

    • Other diseases expected to potentially decrease quality of life, alter survival time, or limit diet options – e.g. significant heart disease, kidney disease, bad liver disease, etc.
    • Current vomiting or diarrhea or a history of chronic vomiting or diarrhea (more than 6 multi-day episodes per year or one month of consistent clinical signs) within the last year that required medications or special diet for control
    • Dogs with anticipated life expectancy of < 4 months
    • Pet owner not willing to feed prescribed diet and limit treats to 5% of calories

    Dogs will be fed either a high quality control diet appropriate for dog maintenance or the specially designed study diet – neither the pet owners nor the researchers will know which diet the dog is getting. Pet owners will need to fill out quality of life surveys as well as diet journals and fecal score journals every 1-2 weeks, and bring their dogs in for study visits/chemotherapy every 2 weeks. At three points during the study, blood and urine will be collected from fasted dogs.

    Treats and dietary supplements will need to be restricted to only those provided on an approved treat and supplement list.

    Client Benefits:

    The study will cover the costs of all study-related blood work and visits.  You will also receive free high quality pet food for the two month study duration and a $300 credit towards your account balance when you and your dog successfully complete the study and return all study-related paperwork.  The study does not include the costs of cancer staging (including those required to determine study eligibility), or any costs associated with surgery or chemotherapy, additional blood work not required for the study, or follow-up visits outside of those described above.  Your dog’s participation will also allow us to gain information which will help in the management of other dogs undergoing chemotherapy.

    Contact Information:

    To make an appointment with the oncology department please call the oncology liason, Kelly Reed at 508-887-4682

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