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.email@example.com, (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.
- Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees: Ms. Dawn Meola (firstname.lastname@example.org, 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 email@example.com.