Title:

Use of Equine CenTrate® Bone Marrow Aspirate (BMA) in horses with hindlimb proximal suspensory desmopathy (HPSD)

Investigators:

John Peroni DVM, MS, DACVS (Large Animal Medicine, Surgery and Lameness Service faculty)

If interested please contact Dr. Peroni at [email protected], or our Clinical Trials Coordinator Lisa Reno via email ([email protected]) or phone at 706-296-7818.

Study description:

Hindlimb proximal suspensory desmopathy (HPSD) is a common cause of lameness in horses. Nonsurgical conventional treatments of HPSD include local infiltration with corticosteroids and/or hyaluronan, extracorporeal shock wave therapy, and systemic application of NSAIDs in combination with corrective shoeing. However, each of these have shown poor long-term results. Treatment of ligament injury utilizing orthobiologics such as platelet rich plasma (PRP) or a bone marrow aspirate (BMA) have been advocated to improve healing of these injuries. We hypothesize that intralesional treatment with CenTrate® BMA will improve the architecture of the injured suspensory ligament, as examined via ultrasound and MRI, returning horses to the expected level of athleticism more rapidly and with a lower rate of recurrence than horses treated with standard of care.

Horses presenting with hindlimb suspensory injury will be randomized to receive standard of care therapy (consisting of a carefully structured rest and rehabilitation program including systemic NSAIDs, topical treatment, etc. according to individual needs), or receive CenTrate® BMA in addition to standard of care therapy. The study is 8 months in duration.

*Horses that are not initially randomized to receive CenTrate® BMA will be offered rescue treatment with BMA, if 90 days of the current standard of care regimen have passed without improvement.

Inclusion criteria:

• Adult horses >4 years of age that have reached skeletal maturity.
• Lameness localized to the proximal metatarsal region
• Clinical work up must confirm lesion localization via local infiltration of the suspensory apparatus or perineural anesthesia of the deep branch of the lateral plantar nerve.
  • Unilateral HPSLD – contralateral hindlimb WNL on ultrasound and radiographs.
  • Bilateral HPSLD that is evident on lameness and able to be localized on both limbs with local anesthetic.
• Free of NSAID, steroid, or other therapies (topicals, shockwave) for at least 7 days prior to proposed date of BMA administration.
• Owner willing to comply with recheck and rehabilitation schedule for 8 months.

Exclusion criteria:

• Horses under 4 or greater than 20 years of age
• Horses with a prior history of suspensory surgery

Horses will be screened for study inclusion based on history, physical and lameness examination, labwork, radiographs and ultrasound examination to confirm location of injury. Horses meeting inclusion criteria will be admitted to the hospital to have a baseline MRI under anesthesia. Horses will be recovered and the following day will be sedated and receive a local anesthetic for bone marrow aspiration, which is commonly performed in most advanced hospital settings. Horses randomized to receive CenTrate® BMA will have the BMA injected into the affected suspensory ligament.

All horses will return for recheck visits to the hospital at months 1, 2, 3, 5, and 8 post enrollment, during which physical examination, lameness exam and ultrasound will be repeated. A follow-up MRI under anesthesia will be repeated at month 3 to assess imaging changes that may not be discernible with ultrasound. Horses assigned to the standard of care group initially will have the opportunity to receive treatment with CenTrate® BMA if improvement is not seen after 90 days of therapy.

Study funds are available to cover a substantial amount of the costs of each visit and associated diagnostics (ultrasound and MRI). In addition study funds will cover costs of the CenTrate® BMA treatment. Owners are financially responsible for pre-enrollment diagnostic costs. Stem cells will be developed from each horse’s bone marrow at no additional cost to owners, and will be available for future treatments or available for any additional injury the horse might sustain and stored at the University of Georgia for up to two years.

Duration of study:

This study is currently OPEN.

Potential benefits to veterinary medicine:

The use of orthobiologics such as bone marrow aspirate have shown promise in assisting the recovery of ligament injury in horses. This controlled study will provide critical information regarding the outcome of hindlimb high suspensory injury in horses.