Randomized controlled trial demonstrates the benefit of RGTA® based matrix therapy to treat tendinopathies in racing horses.
Abstract: A randomized controlled trial was performed on racing horses, to evaluate the efficacy of a new class of therapeutic agents in regenerative medicine-ReGeneraTing Agents® (RGTA®), to treat tendinopathies. Preliminary uncontrolled studies on tendon healing in racing horses with RGTA® (OTR4131)-Equitend® showed encouraging results, justifying performing a randomized, controlled, multicenter study with a two-year racing performance follow up. The objective of this study was to evaluate the effect of Equitend® versus placebo on acute superficial digital flexor tendonitis in racing French Standardbred Trotters (ST). Twenty-two ST were randomly and blindly assigned to receive with a ratio of 2 to 1, a single Equitend® (n = 14) or placebo (n = 8) intralesional injection under ultrasonographic guidance. Horses were evaluated over 4 months, by clinical and ultrasonographic evaluations (day 0, months 1, 2, 4), and their racing performances followed up over the 2 years after treatment. During the first month of treatment, a significant decrease in the cross-sectional area (CSA) was found in the Equitend® group (p = 0.04). After 4 months, the number of Equitend® treated horses with an improved CSA was significantly higher than the placebo-treated horses (p = 0.03571). The Equitend® group returned to their pre-injury performance level, racing in, and winning, significantly more races than the placebo group (p = 0.01399 and 0.0421, respectively). Furthermore, recurrence was significantly higher in the placebo group than in the Equitend® group (71.4% vs 16.6%, p = 0.02442). In conclusion, we measured a significant, short-term, reduction effect on CSA and demonstrated a long-term beneficial effect of intralesional injection of Equitend® for the treatment of superficial digital flexor tendonitis on racing ST, racing 2. 3 times more often than placebo, with 3.3 times fewer recurrences maintaining pre-injury performance level. This study may open the way for the development of a human treatment of tendonitis.
Publication Date: 2018-03-09 PubMed ID: 29522564PubMed Central: PMC5844532DOI: 10.1371/journal.pone.0191796Google Scholar: Lookup
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- Journal Article
- Multicenter Study
- Randomized Controlled Trial
- Research Support
- Non-U.S. Gov't
Summary
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The research article focuses on a controlled trial on racing horses to determine the efficacy of ReGeneraTing Agents® (RGTA®) in treating tendinopathies. Horses treated with Equitend®, a type of RGTA®, showed significant improvement in tendon healing and fewer instances of recurrence compared to those receiving a placebo, indicating its potential as a therapeutic agent.
Experiment Methodology
- The research team conducted a randomized controlled trial on racing horses with superficial digital flexor tendonitis, a common form of tendinopathy in the said animals.
- A total of twenty-two French Standardbred Trotter horses were randomly assigned, with a ratio of 2:1, to receive either an intralesional injection of Equitend® (n=14) or a placebo (n=8), both administered under ultrasonographic guidance.
- Clinical and ultrasonographic evaluations were carried out over a four-month period (day 0, months 1, 2, 4), and the horses’ racing performances were tracked for two years following the treatment.
Results of the Trial
- During the first month, there was a significant decrease in the cross-sectional area (CSA) – an indicator of injury size – within the Equitend® group, indicating an initial improvement in tendon healing.
- After four months, the number of horses treated with Equitend® showing improved CSAs was significantly higher than that of the placebo group.
- In terms of racing performance, the horses in the Equitend® group were able to return to their pre-injury levels, participating in and winning more races than the placebo group.
- Additionally, recurrence of tendonitis was significantly lower in the Equitend® group (16.6%) as compared to the placebo group (71.4%).
Conclusion of the Study
- The study concluded that the use of Equitend® – a type of RGTA® – demonstrated both significant short-term reduction effects on CSA and long-term beneficial effects in treating superficial digital flexor tendonitis in racing horses.
- Horses treated with Equitend® not only raced 2.3 times more often than the placebo group but also had 3.3 times fewer recurrences, maintaining their pre-injury performance level.
- The success of this study suggests potential for the development of a similar treatment for tendonitis in humans.
Cite This Article
APA
Jacquet-Guibon S, Dupays AG, Coudry V, Crevier-Denoix N, Leroy S, Siñeriz F, Chiappini F, Barritault D, Denoix JM.
(2018).
Randomized controlled trial demonstrates the benefit of RGTA® based matrix therapy to treat tendinopathies in racing horses.
PLoS One, 13(3), e0191796.
https://doi.org/10.1371/journal.pone.0191796 Publication
Researcher Affiliations
- Centre d'Imagerie et de Recherche sur les Affections Locomotrices Equines, Ecole Nationale vétérinaire d'Alfort, Maisons-Alfort, France.
- Unité Sous Contrat 957, Biomécanique et Pathologie Locomotrice du Cheval, Institut National de la Recherche Agronomique, Ecole Nationale vétérinaire d'Alfort, Maisons-Alfort, France.
- Clinique du Molinel, Marcq en Baroeul, France.
- Centre d'Imagerie et de Recherche sur les Affections Locomotrices Equines, Ecole Nationale vétérinaire d'Alfort, Maisons-Alfort, France.
- Unité Sous Contrat 957, Biomécanique et Pathologie Locomotrice du Cheval, Institut National de la Recherche Agronomique, Ecole Nationale vétérinaire d'Alfort, Maisons-Alfort, France.
- Unité Sous Contrat 957, Biomécanique et Pathologie Locomotrice du Cheval, Institut National de la Recherche Agronomique, Ecole Nationale vétérinaire d'Alfort, Maisons-Alfort, France.
- Episcience, London, United Kingdom.
- Organ, Tissue, Regeneration, Repair and Replacement Société Actions Simplifiés, Paris, France.
- Organ, Tissue, Regeneration, Repair and Replacement Société Actions Simplifiés, Paris, France.
- Organ, Tissue, Regeneration, Repair and Replacement Société Actions Simplifiés, Paris, France.
- Laboratoire de recherche sur la Croissance Cellulaire, Réparation, et Régénération Tissulaire, Faculté des Sciences, Université Paris-Est Créteil, Créteil, France.
- Centre d'Imagerie et de Recherche sur les Affections Locomotrices Equines, Ecole Nationale vétérinaire d'Alfort, Maisons-Alfort, France.
- Unité Sous Contrat 957, Biomécanique et Pathologie Locomotrice du Cheval, Institut National de la Recherche Agronomique, Ecole Nationale vétérinaire d'Alfort, Maisons-Alfort, France.
MeSH Terms
- Animals
- Double-Blind Method
- Female
- Follow-Up Studies
- Glucans / therapeutic use
- Horse Diseases / diagnostic imaging
- Horse Diseases / drug therapy
- Horses
- Kaplan-Meier Estimate
- Male
- Odds Ratio
- Recurrence
- Running / injuries
- Tendinopathy / diagnostic imaging
- Tendinopathy / drug therapy
- Tendinopathy / rehabilitation
- Tendinopathy / veterinary
- Tendons / diagnostic imaging
- Tendons / drug effects
- Time Factors
- Treatment Outcome
- Ultrasonography
Conflict of Interest Statement
Competing Interests: D.B. is OTR3 founder and inventor with patents and a significant OTR3 shareholder. F.S. holds some shares of OTR3 company and is an employee of OTR3. FC is an employee of OTR3. Equitend® is a product under development and a dossier has been submitted to the EMA authority. Patents’ names and numbers in relation with the Equitend® product are described in“Financial Disclosure”. This does not alter our adherence to PLOS ONE policies on sharing data and materials, S.J.G, A.G.D, V.C, NCD, S.L and J.M.D. have declared that no competing interests exist. Patents’ names and numbers in relation with the Equitend® product are described below: Title: Method for sulphonation of compounds comprising free hydroxyl (oh) groups or primary or secondary amines. Family: BIP119919 - BIP119919AUPC AUSTRALIA 2002365302 28/11/2002 2002365302 11/06/2009 BIP119919CAPC CANADA 2,468,759 28/11/2002 BIP119919CNPC CHINA 02827691.4 28/11/2002 02827691.4 29/11/2006 Cover Letter BIP119919ILPC ISRAËL 162192 28/11/2002 BIP119919INPC INDIA 314/MUMNP/2004 28/11/2002 211390 26/10/2007 BIP119919JPPC JAPAN 2003-547462 28/11/2002 4394950 23/10/2009 BIP119919USPC UNITED STATES 10/853,323 28/11/2002 7,396,923 08/07/2008 BIP119919BEEP BELGIUM 02803847.9 28/11/2002 1456247 29/08/2007 BIP119919CHEP SWITZERLAND 02803847.9 28/11/2002 1456247 29/08/2007 BIP119919DEEP GERMANY 02803847.9 28/11/2002 1456247 29/08/2007 BIP119919ESEP SPAIN 02803847.9 28/11/2002 1456247 29/08/2007 BIP119919FREP FRANCE 02803847.9 28/11/2002 1456247 29/08/2007 BIP119919GBEP UNITED-KINGDOM 02803847.9 28/11/2002 1456247 29/08/2007 BIP119919IEEP IRLAND 02803847.9 28/11/2002 1456247 29/08/2007 BIP119919ITEP ITALY 02803847.9 28/11/2002 1456247 29/08/2007 BIP119919LUEP LUXEMBOURG 02803847.9 28/11/2002 1456247 29/08/2007 BIP119919NLEP NETHERLANDS 02803847.9 28/11/2002 1456247 29/08/2007 BIP119919SEEP SWEDEN 02803847.9 28/11/2002 1456247 29/08/2007 BIP119919FR00 FRANCE 0115444 29/11/2001 2832708 13/02/2004 Title: Use of biocompatible polymers for the preparation of a composition or a medical device Family: BIP121524 BIP121524AUPC AUSTRALIA 2004285318 28/10/2004 2004285318 04/03/2010 BIP121524CAPC CANADA 2,543,530 28/10/2004 BIP121524CNPC CHINA 200480036221.9 28/10/2004 BIP121524EAPC EURASIA 200600862 28/10/2004 010945 30/12/2008 BIP121524EPPC01 EUROPE 10006666.1 28/10/2004 BIP121524EPPC02 EUROPE 10184844.8 28/10/2004 Published 15/12/2010 under N. 2260853 BIP121524ILPC ISRAËL 175235 28/10/2004 BIP121524ILPC01 ISRAËL 210249 28/10/2004 BIP121524INPC INDIA 1473/CHENP/2006 28/10/2004 BIP121524JPPC JAPAN 2006-537359 28/10/2004 BIP121524USPC UNITED STATES 10/577,637 28/10/2004 BIP121524ATEP AUSTRIA 04805335.9 28/10/2004 1677807 08/09/2010 BIP121524BEEP BELGIUM 04805335.10 28/10/2004 1677807 08/09/2010 BIP121524CHEP SWITZERLAND 04805335.11 28/10/2004 1677808 08/09/2010 BIP121524CZEP CZECH REPUBLIC 04805335.12 28/10/2004 1677809 08/09/2010 BIP121524DEEP GERMANY 04805335.13 28/10/2004 1677810 08/09/2010 BIP121524ESEP SPAIN 04805335.14 28/10/2004 1677811 08/09/2010 BIP121524FREP FRANCE 04805335.15 28/10/2004 1677812 08/09/2010 BIP121524GBEP UNITED KINGDOM 04805335.16 28/10/2004 1677813 08/09/2010 BIP121524HUEP HUNGARIA 04805335.17 28/10/2004 1677814 08/09/2010 BIP121524IEEP IRLAND 04805335.18 28/10/2004 1677815 08/09/2010 BIP121524ITEP ITALY 04805335.19 28/10/2004 1677816 08/09/2010 BIP121524LIEP LIECHTENSTEIN 04805335.20 28/10/2004 1677817 08/09/2010 BIP121524LUEP LUXEMBOURG 04805335.21 28/10/2004 1677818 08/09/2010 BIP121524NLEP NETHERLANDS 04805335.22 28/10/2004 1677819 08/09/2010 BIP121524PLEP POLAND 04805335.23 28/10/2004 1677820 08/09/2010 BIP121524PTEP PORTUGAL 04805335.24 28/10/2004 1677821 08/09/2010 BIP121524SEEP SWEDEN 04805335.25 28/10/2004 1677822 08/09/2010 BIP121524TREP TURKEY 04805335.26 28/10/2004 1677823 08/09/2010 BIP121524FR00 FRANCE 03/12605 28/10/2003 Published 29/04/2005 under N. 2861308 Title: Biocompatible polymers, their process of manufacture and compositions containing them Family: BIP121532 BIP121532CAPC CANADA 2,337,328 20/07/1999 BIP121532EPPC EUROPE 99932921.2 20/07/1999 Published 03/02/2000 under N. 1117695 BIP121532EPPC01 EUROPE 10182823.4 20/07/1999 Published 02/03/2011 under N. 2289970 BIP121532JPPC JAPAN 2000-561226 20/07/1999 4485058 02/04/2010 BIP121532USPC UNITED STATES 10/695,574 20/07/1999 BIP121532USPC01 UNITED STATES12/212093 20/07/1999 BIP121532USPC02 UNITED STATES 09/765,788 20/07/1999 6,689,741 10/02/2004 BIP121532FR00 FRANCE 9809309 21/07/1998 98/09309 08/08/2003.
References
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