Veterinary Clinical Studies: Where Research Meets Clinical Care

As an academic veterinary medical center, the faculty and staff at Cummings School  are constantly exploring new scientific breakthroughs through clinical research studies. These studies may involve the use of a new drug, newly developed medical device, procedure, or a behavioral change, such as diet. With the potential to improve quality of life, clinical trials provide animals with diagnostics and treatments that determine which therapeutic approaches work best for certain diseases or conditions, and have the potential to change the way we practice veterinary medicine.

Benefits of Participation

There are a number of benefits to having a client’s pet participate in a clinical study:

  • You are assured the animal will receive care from a highly specialized support team, who monitor the animal’s health very closely.
  • Some of the costs of participating in the study including medications, blood tests and follow-up may be covered, easing the financial burden of the client.
  • The pet gains access to cutting-edge therapies that are not otherwise available, providing hope for owners, a better quality of life for the pet or even additional years to live.

Above all, many clients find a great sense of reward knowing that they are helping other animals and contributing to the advancement of veterinary medicine.

Strict Review and Protocols are in Place

Each clinical study is led by one principal investigator (PI), who may often be supported by several co-investigators providing the most comprehensive expertise. Currently there just over 70 clinical studies ongoing at Cummings School, all of which have a master plan called a protocol that has undergone rigorous evaluation by the School’s animal review board known as the Clinical Science Review Board (CSRC).

After speaking to personnel with intimate knowledge of the protocol, and prior to entering their animal into a study, all clients must sign informed consent statements. This informed consent includes details about the treatments and tests their animal will receive and a summary of the benefits and risks.

Most often the clients will return to the Foster Hospital for follow-up care, although some clinical studies are so simple that they may only involve sampling at a single point in time. Since many therapies represent new treatment approaches, it is important that the animals adhere to strict protocol guidelines to minimize the possibility of side effects. Any new treatments may have side effects, some which may be anticipated or others that are not expected.

Clinical Studies Underway

Cummings School Clinical Studies Lab has a broad array of trials currently underway, some of which are exploring:

  • canine stem cells used to treat protein-losing enteropathy and protein-losing nephropathy
  • the role of anti-angiogenesis therapy in feline squamous cell carcinoma
  • pimobendan in cats with chronic renal failure
  • metronomic chemotherapy in canine osteosarcoma

A comprehensive and updated list can be found at our clinical studies website (http://sites.tufts.edu/vetclinicaltrials/). Inclusion and exclusion criteria for each study are also specified so you can quickly determine if your patient might be eligible.

The Clinical Studies Lab is staffed full-time by two registered veterinary technicians, Diane Welch and Sarah Cass, who together have more than four decades of experience working with clinical patients.

The success of any clinical trial depends entirely on recruitment and enrollment of an appropriate population of patients. We will keep you informed throughout the clinical study and our goal is always to return your patients to you for ongoing and continued care once the study is complete. We look forward to working with you to bring your clients the most state-of-the-art and innovative therapies and help improve the lives of your patients and those of future generations.

If you have any questions about a particular trial or your patient’s eligibility contact the Clinical Studies Lab by email at clinicaltrials@tufts.edu.

Treatment of canine atopic dermatitis with intravenously administered autologous bone marrow

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 the 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.

For more information regarding this study, please visit: http://sites.tufts.edu/vetclinicaltrials/specialty/dermatology/

Vitamin D Status in Cats with Primary Hepatobiliary Disease

The liver performs an essential role in the absorption of dietary vitamin D and synthesis of the active form of vitamin D. Vitamin D deficiency is a known problem in people with liver disease and these patients routinely receive supplementation. Vitamin D deficiency has not been documented in cats with liver disease. Our goal is to determine if cats with primary liver disease have low levels of vitamin D. If they do this finding could lead to the development of clinical guidelines for vitamin D supplementation.

For more information regarding this study, please visit: http://sites.tufts.edu/vetclinicaltrials/specialty/internal-medicine/

Administration of Pimobendan to Cats with Chronic Kidney Disease (CKD)

A common concurrent condition often appreciated in feline CKD patients is cardiac disease. High rate fluid therapy to treat azotemia puts these patients at risk for congestive heart failure (CHF). Anecdotally at Tufts, an improvement in azotemia, appetite and attitude has been noted in cats treated for cardiac disease with pimobendan that also have kidney disease. We would like to assess tolerability of pimobendan and possible benefits in patients with CKD, IRIS stage 3 or 4. Investigating these initial clinical observations with a larger study will help establish whether pimobendan could be a novel treatment for cats with kidney disease. Benefits could include decreased hospitalization time, improved appetite, improved kidney perfusion with reduced azotemia, and the ability to treat kidney disease while simultaneously protecting against CHF in patients with concurrent cardiac disease.

For more information regarding this study, please visit: http://sites.tufts.edu/vetclinicaltrials/specialty/internal-medicine/