Horstem

Development

EquiCord has carried out an exhaustive research and development process to demonstrate the quality, safety and efficacy of Umbilical Cord Mesenchymal Stem Cells

Clinical development

The authorisation of a product as a veterinary medicine requires the performance of several clinical trials in order to guarantee the safety and efficacy of the medicine.
At EquiCord we have conducted 7 clinical trials for commercialisation authorisation and are currently developing 3 more trials.

Safety and efficacy of MSCs in equine OA

Preclinical

Proof of Concept

Assay on the safety of intra-articular application of allogenic mesenchymal stem cells from equine umbilical cord in healthy horses

Phase I

Single and repeated dose

*VICH GL9

Immunogenicity clinical trial: Cellular and Humoral response

*VICH GL9

Inmunogenicity clinical trial: Cellular and Humoral response

Phase II

Proof of concept for determining safety and efficacy in intra-articular administration of the doses selected of allogenic umbilical cord mesenchymal stem cells in horses with degenerative joint disease

*VICH GL9

Phase III

Determination of safety and efficacy in intra-articular administration of allogenic mesenchymal stem cells from umbilical cord in horses with degenerative joint disease

*VICH GL9

Efficacy and safety study of allogenic mesenchymal stem cells from umbilical cord for the treatment of clinical symptomatology associated with mild to moderate degenerative joint disease (OA) in horses under field conditions

*VICH GL9

Phase IV

Long term follow up study:
Efficacy and safety study 2 years after HorStem administration

Post-authorization Survey Study  about HorStem´s Safety and Efficacy in 800 horses

 

*VICH GL9

Clinical results

Clinical trials designed and conducted by our scientific team have shown that HorStem is effective in reducing lameness in horses with mild to moderate degenerative joint disease.

All of our clinical trials have been carried out following the international standards for the homogenisation of clinical trials VICH GL9 and after authorisation from the Spanish Agency of Medicines and Health Products (AEMPS).

72% of the treated horses reduced their degree of lameness to absence of lameness or inconsistent lameness

(≤grade 1 according to the American Association of Equine Practitioners).

Likewise, long-term studies have shown that the efficacy of HorStem is very long-term, showing that 83% of the animals did not relapse in their symptoms or need additional medication 12 months after the application of HorStem.

Horstem - Lameness reduction chart