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-- CLOSED-- DSCD cells for the treatment of painful and inflammatory musculoskeletal conditions of the lower limb -- CLOSED--
Equine dental stem cells (DSCD) are a regenerative medicine product that may produce sign modifying effects in horses with superficial digital tendonitis, desmitis, or osteoarthritis.
This is a controlled double-blinded prospective clinical trial for horses with degenerative conditions of the distal limb causing lameness. The lower limbs of horses, particularly the tendons and joints, are prone to many traumatic injuries that can lead to chronic lameness and degenerative conditions that could benefit from regenerative medicine approach. The most common conditions amenable to stem cell injections include osteoarthritis, tendonitis, and desmitis (ligament injury). Osteoarthritis is a degenerative disease involving inflammation that affects joints with changes in the subchondral bone. The process causes progressively increasing pain and lameness. Tendonitis is a painful enlargement of an area of injured tendon that can fail to heal and result in scar tissue and loss of limb flexibility. Desmitis is the same condition in a ligament. Injection of stem cells into joints or other blood products such as platelet rich products can reduce inflammation in the joint and has the potential to support the injured cartilage. Pulp stem cells have the ability to regenerate into many types as well as provided extracellular matrix and growth factors to tissue that has failed to heal.
- Lameness and one of three conditions in need of tissue regeneration diagnosed by clinical exam, regional anesthesia and imaging (superficial digital tendonitis, desmitis, or osteoarthritis)
If you decide to allow your animal to be enrolled, an x-ray, blood work, ultrasound, and possibly a urinalysis may be performed. If your horse has lameness, your animal may be lead several times across an in-ground flat metal force plate designed to measure the force with each step is taken. Your horse will be discharged 3 days after the elected injection. The medications will be administered in the joint by sterile injection for the joint studies, and directly into the tendon or ligament by sterile injection for soft tissue studies. Your horse will be followed here at the Veterinary Medical Center for up to 2-3 weeks after the first treatment. During this time, your horse may receive physical examinations, measurements of inflammation such as a circumference of the limb, heat at the surface, limb edema score, force plate exams, blood work, and possibly urinalysis. Your horse may also have an exercise program consisting of walk, trot, and canter, on a treadmill 2-3 times per week to keep the joints limber. You must sign a consent form and maybe required to fill out a pre-study questionnaire.
Once the results confirm your animal can be enrolled, your horse will be assigned at random to one of two groups: either the control placebo group or the treatment group. If your animal is in the control group, you may be offered the option of having the treatment group provided at no additional charge before your horse goes home, provided you agree to fill out the questionnaire 3 months after the horse goes home and cooperate with a phone follow-up call.
- The costs for the data collection, testing, sedation, board, treadmill and force plate, blood and urine analysis and collection, and study treatment will be paid for by the sponsor of these studies. That includes the physical exams, x-rays, ultrasound, and all the biochemical and blood tests.
- You will be notified the date of receiving the injection and therefore the discharge day. You are expected to pick up your horse on the discharge day. If an unexpected even occurs and you cannot pick up your horse on the discharge day, you are allowed a 2-day grace period and then all board is charged to your credit card. You must provide a credit card at our reception prior to leaving your horse for this study.
Alicia Bertone, DVM, PhD, DAVCS, bertone [dot] 1 [at] osu [dot] edu