TY  - GEN
A1  - Küenburg, Bernhard
A1  - Teuschl, Andreas
T1  - Regenerative silk ligament: scale up and regulatory strategy of a textile engineered silk implant for tissue  regeneration of injured human ACL (anterior cruciate ligament)
N2  - 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.
KW  - Biomaterial
KW  - Ligament
Y1  - 
ER  - 
TY  - JOUR
A1  - Teuschl, Andreas
A1  - Heimel, Patrick
A1  - Nürnberger, Sylvia
A1  - van Griensven, Martijn
A1  - Redl, Heinz
A1  - Nau, Thomas
T1  - A Novel Silk Fiber-Based Scaffold for Regeneration of the Anterior Cruciate Ligament: Histological Results From a Study in Sheep.
JF  - The American Journal of Sports Medicine
KW  - Ligament
KW  - Regeneration
Y1  - 2018
ER  - 
TY  - JOUR
A1  - Nau, Thomas
A1  - Redl, Heinz
A1  - Teuschl, Andreas
T1  - Comment on: In Vivo Evaluation of Electrospun Polycaprolactone Graft for Anterior Cruciate Ligament Engineering
JF  - Tissue Engineering Part A
KW  - Grafting
KW  - Ligament
Y1  - 2018
ER  - 
TY  - JOUR
A1  - Nau, Thomas
A1  - Teuschl, Andreas
T1  - Regeneration of the anterior cruciate ligament: Current strategies in tissue engineering
JF  - World Journal of Orthopedics
KW  - Ligament
KW  - Regeneration
KW  - Tissue Engineering
Y1  - 
VL  - 6
IS  - 1
ER  - 
TY  - JOUR
A1  - Teuschl, Andreas
A1  - Aigner, Elmar
A1  - Hohlrieder, Martin
A1  - Cicha, Klaus
A1  - Stampfl, Jürgen
A1  - Redl, Heinz
T1  - Stimulation of ligament tissue formation on a silk scaffold with mechanical loading using a custom-made bioreactor system
JF  - Journal of Tissue Engineering and Regenerative Medicine
KW  - Ligament
KW  - Tissue Formation
KW  - Scaffold
KW  - Silk
KW  - Bioreactor
Y1  - 2018
VL  - 1
IS  - 6
SP  - 51
EP  - 51
ER  -