Stem Cell Therapies

Clinical trials for Stem Cell Therapies

  • Sponsor:  Shipley Foundation

    CSRC Protocol #: 030-14

    Enrollment beginning in February 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

  •  Sponsor:  Shipley Foundation

    CSRC Protocol #: 026-14

    Enrollment beginning February 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

     

  • Sponsor:  Shipley Foundation

    CSRC Protocol #: 027-14

    Enrollment beginning February 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

     

  • Sponsor:  Shipley Foundation

    CSRC Protocol #: 029-14

    Enrollment beginning in February 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