Cryopreserved umbilical allograft (equicenta® CTM) improves clinical outcomes compared with clinician-selected standard of care in performance horses: a pragmatic prospective controlled trial

Introduction This multicenter, prospective, controlled clinical study and client survey evaluated the safety and effectiveness of an equine umbilical tissue suspension (equicenta® CTM; eCTM, 2:1) compared with clinician-selected standard of care (SOC) for treating lame performance horses. Methods This pragmatic, real-world, open-label study enrolled horses diagnosed with appendicular musculoskeletal conditions affecting the joints, tendons, or ligaments under owner consent and an intention-to-treat design with an optional crossover after no improvement at 12 weeks and per-protocol post hoc analyses at 26 weeks. Horses were assigned to eCTM or clinician-selected, non-steroidal SOC; other case management was not different. Ordinal outcomes included lameness, pain, swelling, performance, adverse events, client-reported health, plus ultrasound and gait kinematics at baseline and at 2, 4, and 12 weeks, with veterinary remote follow-up at 26 weeks. Results Enrolled horses ( n = 138) completed 12 weeks, and 135 surviving horses completed 26 weeks. Cumulative improvement was greater for eCTM versus SOC by 2 weeks for pain and swelling, by 4 weeks for lameness, and through 12 weeks for all clinical outcomes ( p < 0.001). Mean and cumulative performance scores were significantly greater for eCTM at 26 weeks, with the odds of returning to or exceeding prior performance favoring eCTM (2.72:1; p < 0.006). Client-reported body condition, hair coat, overall health, and quality-of-life scores were significantly better for eCTM ( p < 0.03), and injection-related adverse events occurred more often in SOC, particularly for joint injections. Kinematic analysis showed significantly greater improvement in lameness with eCTM at impact and push-off. Discussion/conclusion In this pragmatic setting, a single, off-the-shelf injection of eCTM was associated with earlier, greater, and more durable improvements in clinical and performance outcomes than clinician-selected non-steroidal SOC. The open-label design and flexible SOC comparators reflect real-world application of biologics and may have introduced expectation and treatment selection biases, although none were identified in post-sensitivity analyses. The magnitude and consistency of between-group differences across clinical, owner-reported, and kinematic outcome measures suggest an observed treatment effect. Overall, these positive findings suggest that eCTM may offer a single-dose alternative to clinician SOC approaches for selected musculoskeletal conditions in lame performance horses. Clinical trial registration https://studypages.com/dashboard/ unique identifier is VCT #26005934.