Freeze-dried conditioned serum clinical trial
This study, “Safety and efficacy of intra-articular allogeneic freeze-dried conditioned serum (FDCS) in horses with lameness regionalized to the distal interphalangeal joints,” is being performed by the Orthopaedic Research Center through the equine sports medicine service at the Johnson Family Equine Hospital.
We have previously shown that freeze-dried conditioned serum (conditioned serum is also known as IRAP) is well tolerated when injected into equine joints in a research setting. This current study investigates the safety and efficacy of FDCS in a clinical setting, in adult horses with lameness isolated to the front feet. Specifically, the study aims to demonstrate that intra-articular FDCS is safe when injected into the front coffin (distal interphalangeal; DIP) joints and that it is effective in reducing lameness compared to a placebo control.
- This is a 21-day study
- Horses will be randomly assigned to receive either the placebo or the FDCS treatment. Veterinarians and owners will be blinded to the treatment. Treatments will be performed at days 0, 7, and 14 (+/- 1 day).
- Horses will undergo examinations at days 0, 7, 14, and 21 (+/- 1 day) that will consist of documenting vital signs, palpation of the fore DIP joints, and a lameness evaluation.
- Radiographs of both front DIP joints will be taken on day 0 and day 21.
- Horses in the placebo group will be eligible to receive FDCS treatment following the 21-day timepoint.
- Horses of any sex (mare, gelding, stallion) older than 1.5 years of age
- Apparently healthy horse with no ongoing infectious disease(s)
- Bilateral forelimb lameness
- Lamer limb graded Grade 2 to 3 on the American Association of Equine Practitioners (AAEP) lameness scale
- Lameness isolated to the foot region via at least 80% improvement with palmar digital perineurial, abaxial sesamoid perineurial, or intra-articular DIP joint analgesia.
- Lameness is not due to a septic process
- No systematic administration of NSAIDs or corticosteroids within 72 hours of day 0 of the study, nor at any point throughout the 21-day study period
- No intra-articular medication of the front DIP joint(s) within 8 weeks other than IA analgesia to meet inclusion criteria; or intra-articular injection of any other joints within 2 weeks of day 0 of the study; or at any point throughout the 21-day study period.
Enrollment ends December 31, 2023
If interested in enrolling, please contact Dr. Erin Contino at email@example.com.