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Frontiers in veterinary science2026; 13; 1833933; doi: 10.3389/fvets.2026.1833933

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

Abstract: 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. Unassigned: 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 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. Unassigned: Enrolled horses ( = 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 ( < 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;  < 0.006). Client-reported body condition, hair coat, overall health, and quality-of-life scores were significantly better for eCTM ( < 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. Unassigned: 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. Unassigned: https://studypages.com/dashboard/ unique identifier is VCT #26005934.
Copyright © 2026 Bertone, Davern, Sutter, Mesch, Beinlich, Smith, Ramstrom, White, Dubynsky, Cantrell, Hay, Davis and Mazzarelli.
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Publication Date: 2026-08-04 PubMed ID: 42614706PubMed Central: PMC13483253DOI: 10.3389/fvets.2026.1833933Google Scholar: Lookup
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Summary

This research summary has been generated with artificial intelligence and may contain errors and omissions. Refer to the original study to confirm details provided. Submit correction.

Overview

  • This study evaluated the safety and effectiveness of a cryopreserved equine umbilical tissue suspension (equicenta® CTM, or eCTM) compared to standard non-steroidal care (SOC) in treating lameness in performance horses.
  • Results demonstrated that eCTM provided faster, greater, and longer-lasting clinical improvement and better performance outcomes than standard treatments over a 26-week period.

Study Design and Objectives

  • Multicenter, prospective, controlled clinical trial following a pragmatic, real-world, open-label approach.
  • Horses with appendicular musculoskeletal issues affecting joints, tendons, or ligaments were enrolled under owner consent.
  • Subjects were assigned either to receive a single injection of eCTM or clinician-selected non-steroidal SOC treatment.
  • Optional crossover was permitted after 12 weeks if no improvement was observed, with further per-protocol analyses conducted at 26 weeks.
  • Outcomes measured included lameness, pain, swelling, performance, adverse events, client-reported health and quality of life, ultrasound imaging, and gait kinematics.
  • Assessments occurred at baseline, 2, 4, 12 weeks, and veterinary follow-up was performed remotely at 26 weeks.

Key Findings

  • Clinical improvements: Horses treated with eCTM showed significantly greater and faster reductions in pain and swelling by 2 weeks, and lameness improvement by 4 weeks compared to SOC.
  • All clinical outcome measures remained significantly better in the eCTM group throughout the 12-week evaluation period (p < 0.001).
  • Performance: At 26 weeks, mean and cumulative performance scores were notably higher in the eCTM group, with over twice the odds (2.72:1) of returning to or exceeding prior performance compared to SOC (p < 0.006).
  • Client-reported health: Owners reported better body condition, hair coat, overall health, and quality of life for horses receiving eCTM (p < 0.03).
  • Adverse events: Injection-related adverse events were more frequent in the SOC group, especially after joint injections, indicating a more favorable safety profile for eCTM.
  • Kinematic analysis: Objective gait assessments revealed significantly greater improvement in lameness at key gait phases (impact and push-off) in the eCTM group.

Interpretation and Implications

  • A single off-the-shelf injection of eCTM led to earlier, larger, and more durable improvements than standard non-steroidal care in treating musculoskeletal lameness in performance horses.
  • The pragmatic and open-label nature of the study, with flexible clinician-chosen SOC comparisons, aimed to replicate real-world veterinary practice but might introduce biases such as expectation or treatment selection bias.
  • Sensitivity analyses did not identify these biases, strengthening confidence in the observed treatment effect.
  • The consistent superiority across clinical signs, owner observations, and objective gait metrics suggests meaningful efficacy of eCTM.
  • These findings support eCTM as a promising single-dose biologic alternative to traditional non-steroidal treatments for certain musculoskeletal conditions in lame performance horses.
  • This could impact equine sports medicine practices by providing a potentially safer, more effective, and convenient treatment option.

Additional Notes

  • The study enrolled 138 horses, with 135 surviving to the 26-week follow-up, ensuring robust sample retention.
  • Use of owner-reported outcomes and kinematic analysis adds valuable multi-dimensional perspectives on treatment effectiveness.
  • Further research may explore long-term outcomes, specific lesion types, and broader applications of the umbilical tissue suspension.
  • For more details or study reference, visit the provided link: https://studypages.com/dashboard/ (unique identifier VCT #26005934).

Cite This Article

APA
Bertone AL, Davern AJ, Sutter WW, Mesch H, Beinlich C, Smith A, Ramstrom C, White S, Dubynsky B, Cantrell K, Hay BP, Davis W, Mazzarelli L. (2026). Cryopreserved umbilical allograft (equicenta® CTM) improves clinical outcomes compared with clinician-selected standard of care in performance horses: a pragmatic prospective controlled trial. Front Vet Sci, 13, 1833933. https://doi.org/10.3389/fvets.2026.1833933

Publication

Frontiers in veterinary science
ISSN: 2297-1769
NlmUniqueID: 101666658
Country: Switzerland
Language: English
Volume: 13
Pages: 1833933
PII: 1833933

Researcher Affiliations

Bertone, Alicia L
  • Department of Veterinary Clinical Sciences, College of Veterinary Medicine, The Ohio State University, Columbus, OH, United States.
Davern, Alec J
  • Tryon Equine Hospital, Charlotte, NC, United States.
Sutter, W Wesley
  • Equine Athletic Veterinary Services, Simpsonville, KY, United States.
Mesch, Hayley
  • Equine Athletic Veterinary Services, Simpsonville, KY, United States.
Beinlich, Christopher
  • Woodland Run Equine Veterinary Facility, Grove City, OH, United States.
Smith, Andrew
  • Peterson Smith Equine Hospital, Ocala, FL, United States.
Ramstrom, Colton
  • Performance Veterinary Equine Services, Ocala, FL, United States.
White, Sarah
  • Austin Equine Hospital, Driftwood, TX, United States.
Dubynsky, Bryan
  • Palm Beach Equine Clinic, Wellington, FL, United States.
Cantrell, Kent
  • Ocala Equine Hospital, Ocala, FL, United States.
Hay, Bill P
  • Tryon Equine Hospital, Charlotte, NC, United States.
Davis, Weston
  • Palm Beach Equine Clinic, Wellington, FL, United States.
Mazzarelli, Louis
  • UltraEquine Health, Glastonbury, CT, United States.

Conflict of Interest Statement

AB was an independent consultant for EPL. The remaining author(s) declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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