AKC Canine Health Foundation Regenerative Medicine Study

Location

This study takes place at Veterinary Orthopedic & Sports Medicine Group, Annapolis Junction, MD. Cell processing will be done off-site at the Equine Medical Center in Leesburg, VA.

Purpose

To evaluate the effectiveness of stem cell and platelet therapy for the treatment of naturally occurring tendon injury in dogs and to compare efficacy of two different types of regenerative therapies.

Background

Supraspinatus tendon injury of the shoulder is common in both companion dogs and canine athletes. It often progresses undiagnosed and results in reduced function, lameness and pain. Failed healing and recurrence frequently occur because unassisted tendon healing results in scar formation. Regenerative therapies aim to accelerate and promote healing through tissue regeneration rather than scarring. There are several types of cells that promote healing, including platelets from blood and stem cells from adipose (fatty) tissue taken from the patient’s own body. In this study, platelet rich plasma (PRP) will be combined with one of two types of cell therapy: concentrated adipose stem cells (ASC) and a mixture of adipose-derived cells called the stromal vascular fraction (SVF). Demonstrating an effective treatment for supraspinatus tendon injury will have profound impact on the treatment of musculoskeletal conditions as well as other types of injuries affecting dogs.

Eligibility

Dogs with primary unilateral supraspinatus tendinopathy and lameness in only the affected limb will be included in the study.

Exclusion Criteria

  • Dogs <1 year of age
  • Dogs weighing <20 lbs. 
  • Dogs that are not healthy enough to undergo general anesthesia
  • Dogs that are affected by concomitant neurologic disease or have a history of any diagnosed malignancy 
  • Dogs with elbow injury or osteoarthritis, or concurrent shoulder conditions (medial shoulder syndrome, primary biceps tendinopathy, osteoarthritis) will be excluded from the study.

Study Design

Canine patients with previously diagnosed unilateral supraspinatus tendinopathy will be randomly assigned to three groups of 20 each. Once enrolled in the study, all procedures including blood and tissue collection and treatment will be blinded—this means the treating veterinarians, research staff and owner will not know which group the patient has been allotted to. Further, all objective outcome measures will be performed and analyzed in a blinded fashion. This prevents bias in the study, and makes the information learned more valuable and reliable.

  • Group 1: Control – autologous cell-free plasma tendon injection 
  • Group 2: ASC/PRP tendon injection 
  • Group 3: SVF/PRP tendon injection 

Owners consent to an initial appointment for evaluation, enrollment and tissue collection and injection, and medical progress exams at 14 days, 45 days and 90 days performed at Veterinary Orthopedic & Sports Medicine Group. At the end of the 90-day study period, Group 1 control patients will be offered the study treatment shown to be most effective. Owners also consent to additional testing, including arthroscopy diagnostic ultrasound, to confirm a diagnosis of supraspinatus tendinopathy and rule out other underlying conditions.

Compensation

Owner is responsible for initial consultation and procedures to determine eligibility. These costs (approximately $4,000) are not reimbursed. This cost includes evaluation, blood work, radiographs, diagnostic ultrasound, and bilateral arthroscopy. These procedures must be completed before a dog can be considered for the trial, as they definitively diagnose supraspinatus tendinopathy, and exclude additional, concurrent injuries.

Upon completion of all initial procedures and medical progress exams only, owner will be reimbursed for the cost of treatment, study-related visits, and study diagnostics as well as the cost for recheck visits for the regenerative medicine portion of the trial (a $3,500 value).

Contact

Jayme Pfisterer, Surgical Coordinator
Email:  jpfisterer@vosm.com  | Phone: 240-295-4400 Ext. 210

Katie Cox, Research Technician
Email:  kcox@vosm.com  | Phone: 240-295-4400 Ext. 215

Please note: This study takes place at Veterinary Orthopedic & Sports Medicine Group, Annapolis Junction, MD. Cell processing will be done off-site at the Equine Medical Center in Leesburg, VA.

If your query is urgent, please call Dr. Sherman Canapp at 240-295-4400 x 210.