Stem Cell Therapies

Clinical trials for Stem Cell Therapies

  • 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:  Trial is fully enrolled

    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

    • This study is currently fully enrolled.
    • 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. Not Currently enrolling patients

    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:  Not currently enrolling patients

    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:  Not currently enrolling patients

    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: currently not enrolling

    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.

  • Enrollment beginning in January 2015

    Description:

    The purpose of the study is to determine whether the administration of canine umbilical cord derived mesenchymal stem cells (UC-MSCs) is safe, and if it will reduce kidney injury to a greater extent than the current standard of care. The study will measure kidney values to see if they stay in or return to a normal range as well as overall survival. Secondarily, the study will monitor for any changes in your dog’s likelihood to form blood clots.

    Inclusion Criteria:

    Dogs presenting with protein-losing nephropathy, hypoalbuminemia (<2.0 g/dl), azotemia (creatinine >2.0), thrombocytopenia (platelets < 160,000), and a hypercoaguable state.

    Any gender, and any breed, weighing > 4 kg (8.8 pounds).

    Able to come back for recheck appointments on days 2, 7, 14, 30 and 3, 6 and 12 months post injection.

    Exclusion Criteria:

    Dogs weighing less than 4 kg (8.8 pounds)

    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.

    Client Benefits:

    The study will cover some of the costs that are typically acrued in the diagnostic evaluation of dogs with protein-losing kidney disease including complete blood count, chemistry profile, urinalysis, urine culture, urine protein creatinine ratio, thromboeslatograph (a clotting profile), antithrombin level (to see if your dog is at risk for forming blood clots), ANA (looking for lupus, an autoimmune disease) , serology for tick borne diseases and leptospirosis. It will also cover an abdominal ultrasound examination and the cost of a kidney biopsy. Kidney biopsy is part of the standard diagnostic workup for dogs with protein-losing kidney disease permits it (not too anemic, platelet count adequate, and not hypertensive). The risks associated with kidney biopsy are blood loss from the biopsy site. Your dog will be monitored closely for 4 hours after the biopsy to make sure that any bleeding stabilizes. Heart rate, respiratory rate, mucus membrane color, and blood count will be monitored hourly. Should there be any evidence of sustained bleeding, your dog will be administered intravenous fluids and if needed a blood transfusion. The cost of the blood transfusion will be the responsibility of the owner. The study will also cover the cost for follow up blood work at the scheduled rechecks during the 365 days of the study. 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

  • Use of allogeneic canine umbilical cord mesenchymal stem cells for the treatment of inflammatory bowel disease and concurrent protein losing enteropathy in dogs: effect on clinical scoring and serum protein levels

    Enrollment beginning January 2015

    Description:

    Dogs get a disease of the intestine called inflammatory bowel disease (IBD) in which the normal lining of the intestine is replaced by inflammatory white blood cells. This inflammation results in poor digestion,  often manifesting as diarrhea, vomiting, and weight loss, and in some cases, loss of protein through the feces. This leads to a severe protein deficiency in the body, called a protein losing enteropathy (PLE). PLE is typically an indication of very severe intestinal inflammation and dogs with this condition may not respond well to typical medications used to treat IBD. In addition the PLE itself can cause fatal complications such as edema, fluid in the abdominal cavity, and blood clots. There is a need for new therapies to treat dog with PLE secondary to IBD. Based on evidence in the literature from pre-clinical and clinical trials in humans, we hypothesize that treatment of dogs with a PLE from IBD with stem cells isolated from the umbilical cords of dogs will modulate the inflammatory response in the intestine and induce clinical remission.

    The purpose of the study is to determine whether intravenous administration of cells called mesenchymal stem cells can improve your dog’s clinical signs as well as their blood protein levels. It is believed that the benefit of these stem cells is related to their ability to suppress inflammation.

    Inclusion Criteria:

    Dogs will have had incomplete response to therapy with prednisone, budesonide and/or cyclosporine (defined by a clinical score (CCECAI) >5), have intolerable side effects on medication, or have the administration of cyclosporine or chlorambucil be financially unreasonable for the owner, as these are the patients who require alternative therapeutic options.

    Dogs with biopsy confirmed IBD and bloodwork confirmed panhypoproteinemia

    (total protein <5.5 mg/dl) will be enrolled. The biopsies may be performed at Tufts if they are not already available for pathologist review.

    Both male and female dogs weighing greater than 11 pounds and any age will be considered for the study.

    Exclusion Criteria:

    Dogs with a urine protein:creatinine (UPC) ratio of >0.5, a baseline cortisol < 2 ug/dL, and a post- prandial bile acids of > 30 uM will be excluded from the study. This will eliminate dogs with protein loss through the kidneys, abnormal production of protein from the liver, or Addison’s disease. These tests can be performed at Tufts.

    All dogs will have an abdominal ultrasound and those with signs of intestinal or extra-intestinal masses will be excluded.

    Yorkshire Terriers, Soft-Coated Wheaten Terriers, and Boxers will be excluded, as these dogs have unique IBD features that respond differently from the general population of dogs.

    Dogs with congestive heart failure, Cushing’s disease, diabetes mellitus, or cancer will also be excluded.

    Client Benefits:

    Expenses associated with giving the injection of stem cells and in evaluating your dog after the injection will be covered. Some initial testing, recheck examinations, and follow-up blood work will be covered. Your pet’s participation will also allow us to gain valuable information which will help in the management and treatment of other dogs with this condition.

     

    Contact Information:

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

     

  • Enrollment beginning January 2015

    Description:

    Currently, no medical treatments have been shown to delay the progression of chronic valvular disease (CVD) in dogs, which is a very common heart disease in dogs. In this disease, heart valves become thickened and can no longer keep blood from leaking backwards, leading to fluid accumulation in the lungs (congestive heart failure, CHF). Surgical repair of the valves has shown potential in reversing some changes from the heart disease and prolonging survival time, but this remains a relatively high-risk surgery that very few veterinary hospitals are capable of performing. The cost of the procedure is also financially prohibitive to most dog owners.

    If we can show that mesenchymal stem cell (MSC) treatment is not only safe but can delay the progression of CVD in dogs, this would be the first non-surgical treatment option available to our canine patients. Our results would also have particular relevance for those human patients who cannot undergo valve repair surgery due to unacceptable anesthetic or surgical risks.

    We hypothesize that MSC therapy is safe when administered intravenously (IV) to dogs in CHF, and MSC therapy will result in improved cardiac function as assessed by echocardiography, cardiac biomarkers, or the quality of life of the patient.

    Inclusion/Exclusion Criteria:                                                                      

    A total of 10 client-owned dogs of any sex or age with active CHF secondary to CVD to the Tufts Foster Hospital for Small Animals will be recruited for this clinical trial. Congestive heart failure will be confirmed on chest x-rays to verify the presence of pulmonary edema (fluid in the lungs).

    Dogs with chronic kidney disease, liver disease, uncontrolled hypothyroidism, cancer, high blood pressure, active infection, metabolic disorders, and autoimmune disease will be excluded from the study.

    Client Benefits:

    The study will cover all of the costs associated with echocardiograms, chest x-rays, bloodwork analysis, blood pressures, ECG monitoring, and recheck exam fees. It will not cover the initial hospitalization cost for congestive heart failure stabilization. It will also not cover any medication costs or costs related to disease of other organ systems. Your pet’s participation will allow us to gain information which will help in the treatment of other dogs with this CVD and CHF. 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

     

  • Enrollment beginning January 2015

    Description:

    Atopic dermatitis (AD) affects approximately 10% of the canine population globally and is likely the most prevalent skin disease in the dog requiring medical intervention.  Current treatment options for canines include antihistamines, corticosteroids, cyclosporine A, oclacitinib, and allergen-specific immunotherapy (ASIT) administered subcutaneously or sublingually, as well as adjunctive treatments such as topical and systemic antimicrobial therapy. Avoidance of implicated allergens is impractical or impossible in most cases. The problem with the above treatment options is that they are not entirely reliable therapeutic modalities, have potential for adverse reactions, or they come with significant financial burden. There is a great need for finding a novel, safe, and effective treatment for the management of canine AD.

    Multipotent mesenchymal stem cells (MSCs) have been extensively evaluated in human medicine for their clinical applications in the repair of damaged tissues and in the treatment of chronic, degenerative inflammatory diseases because of their diverse wound healing and anti-inflammatory properties.

     

    Our primary goal is to investigate the efficacy of autologous Bone Marrow MSCs (BM-MSCs) in alleviating the clinical signs associated with canine AD and the safety of BM-MSCs given that no prior safety study has been performed at our hospital. Our secondary goal is to investigate the feasibility of this protocol for future applications in larger scale randomized controlled double-blinded clinical trials.

    Inclusion Criteria:

    1. Males or females, neutered or intact, greater than one year of age

    2. Have a minimum body weight of 10 kg

    3. Have a diagnosis of AD made based on history, clinical signs, exclusion of all other pruritic disease, meeting the de facto established criteria by Willemse and Prelaud. Cutaneous adverse food reaction will have been ruled out using a novel protein elimination diet trial for 8 weeks with no subsequent change in pruritus level following a provocation trial.

    4. Must be on and remain on ectoparasite preventatives for the duration of the trial.

     

    Exclusion Criteria:

     

    1. Pre-existing immune-mediated disease requiring the chronic use of corticosteroids, cyclosporine A, or other immunomodulatory drug

    2. History of treatment with immunosuppressive or immunomodulatory therapy (corticosteroids, cyclosporine A, oclacitinib) for greater than six months

    3. Inadequately treated skin infection

     

    Client Benefits:

    The study will cover all of the costs associated with this study. If an adverse event, such as an allergic reaction should occur, the study would cover the cost of treatment up to a limit of $500; adverse reactions or other complications will be managed by our ICU staff.

    Your pet’s participation will allow us to gain information, which will help in the diagnosis/management/treatment of other dogs/cats/horses/others with this condition. You understand that your animal’s participation in this study may not alleviate or cure his/her ailment.

     

  • Enrollment beginning in January 2015

    Description:

    Cardiomyopathy is a common affliction of the Boxer breed that is manifested by serious ventricular arrhythmias, dilation and reduced vigor of contraction of the heart, or both. The arrhythmic form of the disease bears a striking resemblance to arrhythmogenic right ventricular cardiomyopathy (ARVC) in people, an important cause of sudden cardiac death in young human athletes that is characterized by replacement of the normal heart muscle by fat, scar tissue, and inflammation.

    Current treatment strategies focus on controlling symptomatic arrhythmias, however no medical treatment has been shown to prevent sudden cardiac death. Current therapies also fail to address the underlying structural changes in the heart muscle that inexorably progress, resulting in worsening arrhythmia, cardiac dilation and, in some patients congestive heart failure.

    Mesenchymal stem cells (MSCs) exert anti-inflammatory and anti-fibrotic effects that may prove useful in attenuating the inflammation and remodeling of the heart muscle that characterizes the disease, in turn improving arrhythmia frequency and potentially quality of life or survival times of dogs with ARVC. The major goal of this study is to evaluate preliminary safety of intravenous administration of MSCs in Boxers with ARVC, and to assess their effect on arrhythmia frequency, improving cardiac structural abnormalities, or prolonging survival in affected animals by reducing inflammation or deposition of scar tissue in the heart.

    Inclusion/Exclusion Criteria: 

    A total of 12 client-owned Boxers of any sex or age with cardiomyopathy will be enrolled in this study. Dogs with advanced congestive heart failure, clinically significant congenital heart disease, kidney or liver disease, cancer, active infection, or autoimmune disease will be excluded from the study.

    Client Benefits:

    The study will cover the costs for your dog’s bloodwork, echocardiogram, blood pressure measurement, ECG and Holter monitoring, 4 hours of observation and continuous ECG monitoring following the injection, and recheck visits during the 6 month study period. The study will also cover up to $500 of any costs incurred due to complications from the study; it will not cover any other medication or hospitalization costs. Your pet’s participation will allow us to gain information which will help in the treatment of Boxers and potentially people 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