Protocol identification: CSRC 006-13, approved 3/25/13
Sponsor: Advanced Cell Technology, Marlborough, MA
Principal Investigator: Cynthia Leveille-Webster, DVM, DACVIM (SA Internal Medicine)
Contact information: firstname.lastname@example.org, (508) 839-5395, ext 84542
Status of trial: not currently enrolling
Inclusion criteria: Labrador Retrievers with histological diagnosis of moderate to severe chronic hepatitis (based on ‘Cornell hepatic scoring system’ which grades interface hepatitis, portal inflammation and lobular apoptosis/necrosis) and a serum ALT that is at least 3 times the upper limit of normal will be enrolled.
Exclusion criteria: presence of infectious disease (positive cultures of the liver or bile or positive titers for Leptosporosis), exposure to known hepatotoxic medications or supplements within the last month, the presence of extrahepatic bile duct disease (revealed by diagnostic imaging), severe co-morbidity (cardiac, renal or respiratory disease, evidence of end stage hepatic failure signified by the presence of large volume ascites, serum albumin less than 1.5 g/dl or clinical scores greater than 12), a histopathologic diagnosis of cancer and the presence of thromboembolic disease (splenic or portal vein thrombosis on ultrasound). Evidence of SIRS or shock of any origin would exclude the patients. Patients receiving corticosteroids within the last 2 months would be excluded.
Arms / interventions: This is a single arm open-label pilot study. All dogs (n=6) in this study will receive a single intravenous injection of hES-MSCs once eligibility criteria are met. Standard of care will be maintained throughout the trial with exception that dogs will not be able to receive corticosteroids or immunosuppressive agents for the first 42 days after injection of MSCs.
Potential direct or indirect benefits from the study (for owners and RDVM): The study will cover some of the costs. Owners will be reimbursed for the expenses associated with the liver biopsy (including charges for the laparoscopic surgery and the charges for the pathologist to examine the slide) IF the biopsy is supportive of the diagnosis. All of the expenses associated with giving the injection of stem cells and in evaluating your pet after the injection will be covered. This will include CBC and serum chemistries at 1, 3, and 6 weeks and 3 and 6 months after stem cell injections.
- Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees: Ms. Dawn Meola (email@example.com, 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 firstname.lastname@example.org.