Press release

FIRST OFFICIAL TISSUE ESTABLISHMENT IN SLOVENIA

Educell is the leading Slovenian company for cell therapy, and, in November 2008, was the first company in Slovenia to gain the status of Tissue Establishment. It also makes human tissue and cell based products available for patients in Slovenia.

Slovenian patients with mandatory health insurance have the right to free medical services at the tertiary level. This means that treatment by cell therapy with tissue engineering products, a branch of regenerative medicine, can be provided for patients with special diagnoses. For the past 11 years. Educell has provided patients in Slovenian health institutes with human tissues and cell based products and has also developed new cell therapy and tissue engineering services. The major proportion of its activities lies in processing autologous cartilage cells (a patient’s own cells) for treatment of articular cartilage injuries. The other main focus in the company is research and development in the fields of orthopaedics and traumatology (treatment of injuries in knee articular cartilage and long bones), urology (treatment of vesicoureteral reflux) and stomatology (treatment of oral bony defects).

 

While cell and tissue engineering therapies are in a phase of active development worldwide, the production of commercial tissue engineering products is still in its early stages because of the highly specific characteristics of this high-tech field. In this field Slovenia is well up with the leading countries. Since the introduction of tissue engineering products for treatment of articular cartilage, Educell has been integrating these findings into clinical practice in close collaboration with specialists from the orthopaedic and traumatology clinics of University Medical Centre in Ljubljana and the Blood Transfusion Centre of Slovenia. Further, Educell has been working closely with the Department of Urology in the University Medical Centre, Ljubljana, and has developed an innovative and prospective treatment for vesicoureteral reflux, involving the implantation of autologous cartilage cells from elastic cartilage.

 

Legislation on the supply of human tissues and cells, basic to the field of treatment with human tissues and cells, was accepted by the European Union in 2004. Implementation of this legislation in Slovenia took place in 2007 and 2008. Educell was, in November 2008, the first company to gain the status of Tissue Establishment from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia. This license confirms that the company meets the standards of, and manages the systems for, quality, which guarantees the production of quality, safe and effective cell products for treatment of articular cartilage (ChondroArtÔ), bone tissue (BoneArtÔ) and vesicoureteral reflux (UroArtÔ).

 

Cell products made from autologous human tissue and cells constitute a new form of treatment, in which every product is made specifically for an individual patient. Every patient is treated individually and the cell products are »custom made«. Doctors can order for an individual patient the exact quantity and type of cell product, depending on the size of the injury. The process of making these cell products is technically very demanding, so only experienced and qualified personnel are involved in their production.

 

It is important to emphasize that, according to European and Slovenian ethical principles and legislation, human tissue and cells may only be harvested with voluntary and charge-free donations, regardless of the purpose (both for allogeneic and autologous treatment). This requires constant efforts to ensure high security standards for tissue and cells, which diminishes the danger of trading with human body parts and ensures the protection of health.