Protocol identification: CSRC 038-13, approved 10/9/13
Sponsor: Advanced Cell Technology, Marlborough, MA
Principal Investigator: Mike Kowaleski, DVM, DACVS / EVCS (Surgery)
Contact information: firstname.lastname@example.org, (508) 839-5395 ext 84659
Status of trial: Enrollment start date, Jan 27, 2014.
Inclusion criteria: Signalment: 15-10 kg; 10 months – 12 years of age; any gender. Chronic, bilateral elbow osteoarthritis resulting in symptomatic forelimb lameness secondary to elbow osteoarthritis evident on clinical examination, confirmed radiographically with no clinical, hematological, or biochemical evidence of systemic disease.
Exclusion criteria: Systemic disease, other sources of musculoskeletal lameness (e.g. polyarthritis), reliance on daily oral NSAID or steroid therapy, aggression or behavioral disorders, exercise intolerance, recent (< 3 months) joint injections of non-cell or platelet derived products, or recent (< 6 months) elbow joint surgery.
Arms / Interventions: This is a single arm open-label pilot study of 6 patients. The elbow joint of the lamer limb will be injected with hESC-MSCs. The joint injections will be performed with standard sterile technique, under heavy sedation.
Potential direct or indirect benefits from the study: The study will cover all costs associated with screening candidates including radiographs and associated sedation. The study will also cover the costs of administering the hES-MSC treatment and all follow up hospital visits and exams, including initial and 2, 4, 8, and 12 weeks.
- 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.