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Kuros Treats First Patient With KUR-023

28-02-2011. Kuros Biosurgery AG, a biotechnology company focused on the development of novel biomaterials and bioactive-biomaterial combination products for trauma, wound and spinal indications, announced today that it has treated the first patient in a pilot clinical trial investigating the safety and efficacy of KUR-023, its novel dural sealant product candidate.
KUR-023 is a synthetic hydrogel-based sealant that utilises Kuros' synthetic technology. The product candidate is administered as a spray with the aim of ensuring water-tight closure of incisions or tears through the dura mater.  It is intended to be used as an adjunct to normal closure techniques such as suturing. The trial is a European, single arm, multi-center, study that will recruit 40 patients. The primary endpoint refers to the prevention of intraoperative leakage with secondary endpoints related to safety and further efficacy assessment. KUR-023 is delivered from a double barrelled syringe with a mixing spray tip. The product candidate is delivered as a spray which then arrives on the dura as a liquid, conforms to the surface, and quickly polymerises.  The applied gel is expected to adhere strongly to the dural surface and be able to withstand cerebral pressures in excess of those experienced in a patient. The gel is designed to be easy to apply, to swell minimally (addresses a common problem with hydrogels), to dissolve over a period of a few months and not to interfere with the natural healing process. Kuros’ synthetic technology is based on technology originally developed by Prof. Jeffrey Hubbell. The technology uses a cross-linking chemistry which is highly specific, does not generate any heat and is an addition reaction, meaning that no chemicals are released during the polymerisation process. Didier Cowling, Chief Executive Officer of Kuros, commented: “Our dural sealant candidate, KUR-023, is our most advanced product candidate that is based on our proprietary synthetic technology platform.  Initiation of this clinical study is an important milestone for Kuros.

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TETEC: What is NOVOCART™Disc?

November 2009. The disc-cell product NOVOCART™Disc is a cell suspension aiming a biological treatment of human intervertebral disc defects.
The autologous disc-cell product NOVOCART™Disc is characterized by:
·    High cell viability
·    Individual manufacture for each patient
·    Use of autologous sera
·    Synthesis of most important matrix components (type II collagen and aggrecan)
·    Synthesis of most important growth- and differentiation factors
·    No over-expression of inflammatory cytokines (interleukin-1ß or dedifferentiation markers (type I collagen)
·    Manufacture an delivery within two weeks from cartilage harvest
·    No supplementation of antibiotics or antimicotics
The biological intervertebral disc reconstruction
The Autologous Disc Cell Transplantation (ADCT = transplantation of intervertebral disc cells cultured in vitro) is at present the only method, which allows a biological reconstruction of a partially destroyed or damaged intervertebral disc. The ADCT is very similar to the ACT for the knee joint with respect to its indication and impact. For both procedures the desired effect, i.e. the biological reconstruction, is produced by cells isolated from a biopsy and cultured in laboratory.
Description of the ADCT with NOVOCART™DISC
The transplantation of the cultivated cells takes place three months after harvesting the intervertebral disc biopsy. This quite long time lapse between biopsy harvest and transplantation is necessary to allow healing of the outer ring  (annulus fibrosus) of the intervertebral disc in order to regain a disc-containment.

 

Disclaimer: You agree that B2Bioworld is not responsible and will not be held liable for any third party content on its sites or any third-party content, products or services available on other web sites accessed through links from B2Bioworld sites. Links to third-party sites are for your convenience only, and their inclusion on B2Bioworld's sites does not imply any endorsement, guarantee, warranty or representation by B2Bioworld.

 

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