PAGE FOR EXPERTS

PRODUCTS & TECHNOLOGIES

CELL THERAPIES
Cell therapies, especially therapies utilising mesenchymal stromal/stem cells (MSCs), offer a novel treatment approach in shifting from merely treating the symptoms and slowing the progression of the disease to curing the disease utilising the body’s own ability to regenerate.
Multipotent MSCs have been extensively investigated as cell therapeutic products due to their innate capacity to restore homoeostasis in inflamed, injured or diseased tissues.
While initial therapeutic efforts were based on the cell’s multipotency and differentiation potential, the discovery of their immunomodulatory and trophic properties opened the doors for the treatment of a wide array of immune-mediated diseases.

MSC SCIENCE

Mesenchymal stem/stromal cells (MSCs) are multipotent cells capable of differentiating into mesodermal lineages such as adipocytes, osteocytes, and chondrocytes. MSCs were first isolated from bone marrow but it is presently known that they exist in almost all tissues (e.g., adipose tissue, umbilical cord, etc.). MSCs can migrate to the exact place of injury in the body, where they can differentiate and replace damaged resident cells and promote tissue regeneration. However, an even more pronounced mechanism of their action is through paracrine signalling and cell-cell communication. MSCs are capable of secreting a variety of soluble factors and extracellular vesicles with different cargo molecules. They exert an immunomodulatory effect on various cells of innate and adaptive immune systems in inflammatory environments, which is one of their preferred characteristics employed in the development of cell therapy products.

Cells can be used for local tissue regeneration or for their systemic action.

At GaiaCell, we develop and prepare cell preparations of the highest quality. Such preparations bear the suffix Art.

MSC SAFETY

The safety profile of MSC therapy is extremely important because of the increase in the number of patients with various conditions being treated worldwide. Published data obtained from randomised controlled clinical trials involving almost 3,000 patients, together with our case study results, shows that intravenous MSC therapy is safe. Compared to controls, MSC infusion was associated with an increased risk of fever but not with acute infusional toxicity, infection, thrombotic and thromboembolic events, malignancy, or death.

Our ImmunoART MSC product has been infused almost 100 times and reveals the same safety profile as described in larger clinical studies.
ALLOGRAFTS (PARTNERSHIP WITH TISSUE BANKS)

In 2008, GaiaCell was the first cell and tissue establishment in Slovenia to receive this status and has maintained the accreditation to date. In addition to tissue processing for ATMP production, the certificate also allows us to import and distribute human allografts. We are, therefore, a regional centre for human allograft tissue procurement for orthopaedics, traumatology, wound healing and others. Our long-lasting partnership with different tissue banks from the EU and USA enables us to ensure the stable and constant procurement of tissues needed by our partner surgeons.

Allografts are donated human tissues that are most commonly used in tissue reconstruction.

We source allografts from renowned tissue banks in Europe and America:

MEDICAL DEVICES

SYSTEM FOR PLATELET AND CELL ISOLATION FROM BONE MARROW ASPIRATE

Is a system for an autologous platelet and cell separation and it is optimised to provide high concentrations of platelets and cells in low final output volumes with flexibility to process bone marrow aspirate and whole blood using a single kit.

PRP

Platelet Rich Plasma (PRP) is a promising new therapeutic approach in regenerative medicine. PRP is a concentrated preparation of platelets and various growth factors made exclusively from your blood.

NEOLIGAMENTS

Neoligaments are synthetic ligaments woven from polyester yarns. They can be generic or tailored to specific orthopaedic procedures. To make them as patient- and operator-friendly as possible, they were developed according to the recommendations of leading English surgeons.
LEGAL BASIS

TISSUE AND CELLS - EU

  • DIRECTIVE 2004/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
  • COMMISSION DIRECTIVE 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells
  • COMMISSION DIRECTIVE 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells
  • COMMISSION DIRECTIVE (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells

MEDICINAL PRODUCTS - EU

  • DIRECTIVE 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
  • COMMISSION DIRECTIVE (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use
  • REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004

MEDICAL DEVICES - EU

  • REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
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