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: email@example.com, (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.
- 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.