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Use of Vet-Stem Regenerative Cell Therapy in Canine Inflammatory Bowel Disease

Introduction
Inflammatory Bowel Disease (IBD) in dogs is a group of idiopathic, chronic gastrointestinal disorders characterized by mucosal inflammation.1,2 IBD is commonly distinguished from food-responsive and antibiotic-responsive causes of enteropathy by their therapeutic responsiveness to immunosuppressive therapy as opposed to dietary or antibiotic therapy alone. While the underlying cause of IBD remains unknown, accumulating evidence suggest that intestinal inflammation results from altered interaction between gut microflora and the immune system in the mucosa of the host. 3,4

Rationale
A review of the literature regarding cell-based therapy of Crohn’s Disease and Ulcerative Colitis (the two most prominent of the inflammatory bowel diseases in the human) yields a vast array of animal model, human clinical trial, and anecdotal veterinary data that supports the concept of cell therapy of IBD. T cells in the gut mucosa are considered the primary effector cells and are responsible for the production of cytokines that are responsible for inflammation.4 Mesenchymal stem cells have shown the ability to migrate to areas of inflammation, down-regulate inflammation, modulate the immune system, stimulate neoangiogenesis, and repair damaged tissues.5 Human Phase III final studies are underway in the US and other countries with very encouraging outcomes to date.

For these reasons, Vet-Stem is interested in evaluating the use of adipose-derived stem and regenerative cell therapy for IBD in the dog. We do not have controlled data of chronic IBD dogs given intravenous therapy with adipose-derived stem and regenerative cells. The therapeutic value is theorized from the animal model and human data available in the literature and the data regarding mechanisms of action of stem cells. The data collected from these early IBD cases will be used to design a future prospective, placebo-controlled study to answer the questions of what percent of animals are helped, how soon does it help, how long does it work and how often is retreatment necessary. THIS CURRENT PROGRAM IS NOT A CLINICAL TRIAL AND WILL INVOLVE COST FOR THE CLIENT. And although we believe the data support the safety of this type of therapy, there are no veterinary trials supporting the use of this therapy in IBD and there is risk in any procedure.

Recommendations for case selection
Since IBD is essentially a diagnosis of exclusion, it is important that the attending veterinarian do a comprehensive work-up of the other potential causes of gastrointestinal disease (parasites, bacterial, viral, food-related, neoplasia). Vet-Stem does not have a recommended protocol for this work-up and relies upon the training and expertise of the attending veterinarian to make the diagnosis of IBD.

Treatment
Based upon a limited number of treatments of dogs with IBD, one treatment may be sufficient for this use; however, if enough cells are available, Vet-Stem recommends the use of a two-dose regimen of stem cell therapy. If two treatments are used, the doses should be given approximately one week apart. For this special program, if there are enough cells from the initial collection, the thawing of cells for the second IV injection will be included in the initial processing fee. Normal shipping charges apply for both initial treatment and retreatment. No other discounts apply.

Rebate
One of the goals of allowing veterinarians to use stem cell therapy in new disease areas is to gather early case data to help design future prospective trials. To encourage the collection of this preliminary data, Vet-Stem is offering a discounted processing fee of $1350 and a $350 rebate (from full price initial processing fee), paid to the attending veterinarian, upon receipt of a completed case evaluation form from the veterinarian and one from the owner of the treated pet.

For technical assistance, contact your Veterinary Services Manager:

To schedule a case, call a Customer Service Representative at 858-748-2004

References:
  1. Jergens AE, Moore FM, Haynes JS, et al. Idiopathic inflammatory bowel disease in dogs and cats: 84 cases (1987-1990). J Am Vet Med Assoc 1992;201:1603-1608.
  2. Jergens AE,. Inflammatory bowel disease: Current perspectives. Vet Clin North Am Small Anim Pract 1999;29:501-521.
  3. Chichlowski M, Hale LP. Bacterial-mucusal interactions in inflammatory bowel disease. Am J Gastrointest Liver Physiol 2008;295:G1139-G1149.
  4. Lanzoni G, Roda G, Belluzzi A et al. Inflammatory bowel disease: Moving toward a stem cell-based therapy. World J Gastroenterol. 2008;14(29):4616-4626.
  5. Caplan AI, Dennis JE. Mesenchymal stem cells as trophic mediators. J Cell Biochem. 2006;98:1076-1084.


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