- t2cure’s cell therapy is available through cooperating clinical centres
- t2cure cooperates with experienced partners in research and in the industry.
- t2cure's pipeline is built on clinical studies in cardiac and peripheral vascular indications
- t2cure is dedicated to the development of novel progenitor cell-based regenerative therapeutics.
Technology
Bone marrow-derived cells in regenerative therapies
t2cure is focussing on bone marrow-derived cells (BMCs) for use in cardiovascular repair. Bone marrow mononuclear cells (BMCs) can easily be obtained by aspirating bone marrow from the iliac crest under local anaesthesia. BMCs contain a variety of stem cell and progenitor cells, primarily haematopoietic stem cells, mesenchymal stem cell and other multipotential adult progenitor cells.
The mononuclear cell fraction is purified from the bone marrow aspirate by Ficoll gradient centrifugation at a central GMP-compliant manufacturing facility. For cardiac diseases, BMCs are then injected into the coronary arteries via catheter without further in vitro cell propagation. The same principle is applied in the peripheral setting, where BMCs are injected via catheter in the arteries of the limbs.
The pharmaceutical quality of t2cure’s lead product has been certified by the Committee of Advanced Therapies (CAT) under the European Medicines Agency Advanced Therapy Medicinal Product (ATMP) regulations. This is the first time the certification system has been used in the European Union. The CAT carried out a scientific evaluation of the quality data submitted and the certificate confirms that these comply with the technical and scientific standards that would be applied for the evaluation of a marketing authorisation application.