Protocol identification: CSRC 043-13, approval pending clarifications.
Sponsor: Advanced Cell Technology, Marlborough, MA
Principal Investigator: Dominik Faissler, DVM, Diplomate ECVN (Neurology)
PI contact information: firstname.lastname@example.org, (508) 839-5395 ext 88758
Status of trial: Anticipated enrollment start date: Jan 27, 2014.
Inclusion criteria: Chondrodystrophic dogs, any sex, any age range, weight (5-20 kg bwt), paraplegia with absent pain perception in hind legs and tail at admission; extradural compression between T3-L3 diagnosed with myelogram, CT or MRI. Acute disk extrusion confirmed at surgery.
Exclusion criteria: Unable to confirm intraoperative disk extrusion, concurrent disease that could interfere with neurologic recovery, inability to obtain in-hospital follow-up performed at Tufts University by the neurology service, or lack of owner consent.
Arms / interventions: This is an single arm open-label pilot study. Dogs which quality will receive a single subdural injection of hES-MSCs at the time of hemi-laminectomy.
Potential direct and indirect benefits from participation: The study will cover the costs of the stem cell therapy, and recheck examinations at 1, 3, 7, 14, and 42 days and 12 wks, and bloodwork at 7, 14, and 42 days and 12 weeks after hES-MSC treatment.