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

Pharmaceutical development

The development of a drug is a long and complex process where different areas of research come together to guarantee the quality, safety and efficacy of a drug.

HorStem is the world's first medicine based on umbilical cord mesenchymal stem cells, which gives it optimal quality, efficacy and safety for allogeneic use.

Our donors are sport foals, healthy and born at term by natural delivery in arranged breeding centers. All the umbilical cords used in the development of HorStem are obtained by highly qualified personnel who are present at the time of delivery for the correct neonatal care of the animal and optimal tissue collection.

Tissue collection does not affect the normal equine birth process, being a process in line with maximum animal welfare.

Once in our facilities, the umbilical cord is processed following the highest European quality standards.

Our facilities of more than 500m2 of high-tech laboratories have a production room that complies with Good Manufacturing Practices (GMP) of more than 100m2 specially designed for the manufacture of HorStem.

During the manufacturing process, more than 30 Quality Controls are carried out according to the European Pharmacopoeia, including: cell morphology, viability, cell duplications, identity, mycoplasma, genetic stability, foreign viruses, potency, sterility, etc.

Once the manufacturing process is complete, HorStem is packaged in fresh, which means that it can be used directly without the need for handling by the veterinarian and can be applied directly, easily and safely.

1 Breeding mares
2 Birth of the foals
3 Tissue reception
4 Tissue processing
5 Cellular expansion
6 Packaging and final product
7 Shipping and logistics

1. Breeding maresOnly those breeding centers that meet the highest quality standards can work with us. All our studs have veterinary assistance at birth 24h, 24h monitored farrowing crates, a deworming /vaccination program, veterinary medical equipment and the highest quality standards in reproduction. All our foals are high level sports horses or racehorses.

2. Birth of the foalsIn order to interfere as little as possible in the natural process of birth and preserve animal welfare to the maximum, one of the principles of EquiCord, once the foal has been born veterinary staff collect the tissue of the umbilical cord and begin a process of disinfection on farm patented by EquiCord.

3. Tissue receptionIn our facilities the tissue is reviewed by the quality control and logistics department, so that the collection of the tissue as well as its documentation (health status of the mother and foal before and during birth, shipping temperature, etc) meets the established quality standards.

4. Tissue processingThe production department begins the processing of umbilical cord tissue, an eminently manual process carried out by our highly specialised staff. Once the Master Cell Bank is manufactured it is cryopreserved while obtaining the results of quality controls: sterility, mycoplasma, genetic stability, viruses and parasites, purity and identity, blood analysis of the donor foal, etc.

5. Cellular expansionOnce all the results of all quality controls are obtained, the cells are expanded to pass 4 in asepsis conditions following the highest European standards and tested again of all quality controls.

6. Packaging and final productHorStem is packaged ready to use in small batches each week to always guarantee the supply of HorStem throughout Europe

7. Shipping and logisticsHorStem is sent from our factory in Madrid directly to the final veterinarian in less than 24h in validated boxes at a controlled temperature. No minimum orders are required and HorStem can be ordered to be shipped any day of the week.

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.

Seguridad y eficacia de las MSC en OA equina

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