Regenerative silk ligament: scale up and regulatory strategy of a textile engineered silk implant for tissue regeneration of injured human ACL (anterior cruciate ligament)

  • 61 a93591 27-SY-1 Regenerative silk ligament: scale up and regulatory strategy of a textile engineered silk implant for tissue regeneration of injured human ACL (anterior cruciate ligament) Bernhard Küenburg,Andreas Teuschl MorphoMed, Austria In the USA around 370.000 annual ACL ruptures in the predominately young population (age 18-30) following sport injuries cause a lot of pain and long term troubles for the affected patients. The well established standard procedure of autologous tissue transplantation stabilizes the knee and allows sport activities after 9-12 months. However, harvest of autologous tissue such as patellar tendon or semitendinosus (the most frequently used autograft) weakens other body areas and long term data show an increased rate of arthroses (up to 50% after 10 years) associated with ACL reconstructions. Based on numerous preclinical data and data from a 12-month sheep study the scale-up as well as regulatory approval process of a novel textile engineered silk implant as ACL graft have been initiated. It is planned to enter a clinical trial and strive for regulatory approval as a medical class 3 implant. The sheep data (1) have revealed an approximately 50% degradation of the purified medical silk, which acts as scaffold for the regrowth of a new endogenous ligament. The formation of oriented collagenous tissue fibers including vascularization proves a ligament tissue regeneration for the first time. Scale-up and implementation of a commercial process require a defined set of specifications of commercial silkworm (Bombyx mori) silk, a biological raw material sourced from the textile industry as well as adequate analytical methods to characterize the depletion of sericin in the course of the production process. Based on first full scale samples, the defined biocompatibility program has to be executed, in the EU following the ISO requirements of the notified bodies, in the USA determined by the FDA. Upon submission of the full technical documentation as well as the biocompati-bility data, approval of a clinical trial can be achieved in order to demonstrate the clinical efficacy of the silk based ACL graft compared to the gold standard method in two different randomized groups. As primary endpoint the knee stability will be tested by an apparatus supported Lachmann test. In this study, besides the clinical benefit the patient safety is an important goal. The results of this study will be used for achievement of regulatory approval. References: 1) Teuschl A, Heimel P, Nürnberger S, van Griensven M, Redl H, Nau T. Am. J. Sports Med. 2016;44:1547–57. 2) Teuschl AH, van Griensven M, Redl H. Tissue Eng. Part C Methods. 2014;20:431–9.

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Metadaten
Author:Bernhard Küenburg, Andreas Teuschl
Document Type:Lecture
Language:English
Responsibility for metadata:Fachhochschule Technikum Wien
Release Date:2018/10/18
GND Keyword:Biomaterial; Ligament
Publish on Website:1
Open Access:0
Reviewed:1
Invited:1
Keynote:0
Date of the Talk:05.09.2018
Poster:0
Department:Department Life Science Engineering
Research Focus:Tissue Engineering & Molecular Life Science Technologies
Studienjahr:2018/2019
Projects:Import