Allogeneic Adipose-Derived Mesenchymal Stem Cells (Horse Allo 20) for the Treatment of Osteoarthritis-Associated Lameness in Horses: Characterization, Safety, and Efficacy of Intra-Articular Treatment.
Abstract: Osteoarthritis commonly causes lameness in the horse and has a great impact in performance animals. Due to the limitations of current medical therapies, allogenic mesenchymal stem cells (MSCs) may become an alternative method to control inflammation, reduce tissue damage and pain, and therefore improve lameness. We present the results of a regulatory clinical trial testing adipose-derived MSCs (Horse Allo 20) in veterinary (Agencia Española del Medicamento y Productos Sanitarios, Spanish Medicines Agency, Reference number 325/ECV) involving a total number of 80 participants and with 90 days of follow-up period. The manufacturing process of Horse Allo 20 was robust with no influence of the adipose tissue donor (gender, age, or breed), sample origin (intraperitoneal or subcutaneous), or storage conditions (fresh vs. frozen product presentations) on the quality, safety, and efficacy of the drug product. An in vivo safety study showed that local and systemic tolerance was safe even after repeated intra-articular administration (three injections). An in vivo efficacy study demonstrated the efficacy of the treatment after one or two injections by a reduction in lameness (P < 0.05) for an extended period of time (90 days), decreasing the need for prolonged local and/or systemic anti-inflammatory therapies and their well-known deleterious effects and toxicities.
Publication Date: 2018-08-10 PubMed ID: 29978736DOI: 10.1089/scd.2018.0074Google Scholar: Lookup
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- Clinical Trial
- Veterinary
- Journal Article
- Research Support
- Non-U.S. Gov't
Summary
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The study presents results from a clinical trial on horses suffering from osteoarthritis-associated lameness, where allogeneic adipose-derived mesenchymal stem cells (Horse Allo 20) were tested as a treatment option. The approach showed a promising reduction in lameness while maintaining safety and quality measures, proving to be an effective alternative to sustained anti-inflammatory therapies.
Study Background and Methods
- The researchers conducted a clinical trial authorized by the Spanish Medicine Agency. Their objective was to test the safety and effectiveness of a mesenchymal stem cell (MSC) treatment for horses suffering from osteoarthritis-associated lameness.
- Eighty horses were part of this study, which spanned 90 days. The MSC treatment, named Horse Allo 20, is sourced from adipose tissue—which is connective tissue that stores fat.
- The production of Horse Allo 20 took into account several factors such as the gender, age, breed of the fat tissue donor horse, origin of the sample drawn (intraperitoneal or subcutaneous), and the storage condition of the tissue (fresh or frozen).
Safety Evaluation
- An in vivo safety examination was carried out to assess potential side-effects of the treatment. The criteria included local and systemic tolerance after repeated intra-articular administration.
- It was found that Horse Allo 20 was safe even after three injections had been administered. This is significant since the treatment involves administration directly into the joints of the horse, which could raise safety concerns.
Efficacy Assessment
- The effectiveness of the treatment was tested using an in vivo efficacy assessment. This involved measuring the horses’ level of lameness after one or two injections of the stem cell therapy.
- The study revealed a significant reduction in lameness in the treated horses over an extended period (90 days), explicitly indicating the effectiveness of the treatment.
- Moreover, this treatment reduces reliance on local and systemic anti-inflammatory therapies, steering clear of their harmful effects and possible toxicities. This is a significant advantage of the MSC therapy over conventional treatments.
Conclusion
- According to the findings of this clinical trial, allogeneic adipose-derived MSC treatment (Horse Allo 20) appears to be a robust, safe, and effective treatment for osteoarthritis-associated lameness in horses.
- The research carries great implications for the treatment of equine osteoarthritis, offering a promising alternative to traditional approaches, with reduced side effects and toxicities.
Cite This Article
APA
Mariñas-Pardo L, García-Castro J, Rodríguez-Hurtado I, Rodríguez-García MI, Núñez-Naveira L, Hermida-Prieto M.
(2018).
Allogeneic Adipose-Derived Mesenchymal Stem Cells (Horse Allo 20) for the Treatment of Osteoarthritis-Associated Lameness in Horses: Characterization, Safety, and Efficacy of Intra-Articular Treatment.
Stem Cells Dev, 27(17), 1147-1160.
https://doi.org/10.1089/scd.2018.0074 Publication
Researcher Affiliations
- 1 Research and Development , Centauri Biotech S.L., Coruña, Spain .
- 2 Unidad de Biotecnología Celular, Instituto de Salud Carlos III (ISCIII) , Madrid, Spain .
- 3 Hospital Clínico Veterinario , Universidad Alfonso X El Sabio, Madrid, Spain .
- 1 Research and Development , Centauri Biotech S.L., Coruña, Spain .
- 1 Research and Development , Centauri Biotech S.L., Coruña, Spain .
- 1 Research and Development , Centauri Biotech S.L., Coruña, Spain .
MeSH Terms
- Adipose Tissue / cytology
- Animals
- Endoglin / metabolism
- Female
- Horses
- Injections, Intra-Articular
- Lameness, Animal / etiology
- Lameness, Animal / therapy
- Male
- Mesenchymal Stem Cell Transplantation / methods
- Mesenchymal Stem Cells / cytology
- Mesenchymal Stem Cells / metabolism
- Osteoarthritis / complications
- Random Allocation
- Transplantation, Homologous
- Treatment Outcome
Citations
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