Projekt

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Development of an injectable bioactive bulking formulation for long-term treatment of stress urinary incontinence

Gesuchsteller/in Vardar Elif
Nummer 173758
Förderungsinstrument Bridge - Proof of Concept
Forschungseinrichtung Service d'Urologie CHUV
Hochschule Universität Lausanne - LA
Hauptdisziplin Biomedical Engineering
Beginn/Ende 01.04.2017 - 31.03.2018
Bewilligter Betrag 129'904.00
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Keywords (3)

collagen ; injectable bulking agents ; urinary incontinence

Lay Summary (Französisch)

Lead
Des millions de personnes dans le monde, principalement des femmes, souffrent d'incontinence urinaire à l’effort (IUE), une maladie principalement liée au vieillissement et à l'accouchement. Ce projet porte sur la mise au point d’une thérapie injectable minimale invasive qui fournira un soulagement durable aux patients atteints d'IUE.
Lay summary

La fuite d'urine involontaire est due à des muscles faibles n’étant plus assez puissants pour soutenir efficacement et «fermer» l'urètre lorsque la vessie est remplie d'urine. Malheureusement, les options thérapeutiques actuelles ne sont pas efficaces à long terme ou présentent des risques élevés de complications graves. Ainsi, l'objectif principal de ce projet est de développer un gel de collagène bioactif, comprenant une molécule active de régénération musculaire, pour le traitement à long terme d'incontinence urinaire à l’effort. Durant ce projet, le gel de collagène bioactif sera injecté dans un site cliniquement pertinent d'un mini-cochon. Sa stabilité au point d'injection ainsi que la capacité de régénération musculaire seront évaluées sur six mois. De plus, la production de ce gel de collagène bioactif sera standardisée pour faciliter l'approbation du produit en clinique.

Suite à ce projet, une étude toxicologique sera nécessaire pour définir la posologie sûre et efficace de la molécule bioactive régénératrice du muscle. Finalement, le succès de ce projet permettra d'améliorer la qualité de vie de millions de patients incontinents dans le monde entier.

Direktlink auf Lay Summary Letzte Aktualisierung: 13.03.2017

Verantw. Gesuchsteller/in und weitere Gesuchstellende

Name Institut

Mitarbeitende

Name Institut

Publikationen

Publikation
Microfluidic production of bioactive fibrin micro-beads embedded in crosslinked collagen used as an injectable bulking agent for urinary incontinence treatment.
Vardar Elif (2018), Microfluidic production of bioactive fibrin micro-beads embedded in crosslinked collagen used as an injectable bulking agent for urinary incontinence treatment., in Acta Biomater. , 67, 156-166.

Zusammenarbeit

Gruppe / Person Land
Formen der Zusammenarbeit
University of Malaya Malaysia (Asien)
- vertiefter/weiterführender Austausch von Ansätzen, Methoden oder Resultaten
- Publikation
- Forschungsinfrastrukturen
EPFL, Prof. Peter Frey Schweiz (Europa)
- vertiefter/weiterführender Austausch von Ansätzen, Methoden oder Resultaten
- Publikation
- Forschungsinfrastrukturen
EPFL, Prof. Matthias Lutolf Schweiz (Europa)
- vertiefter/weiterführender Austausch von Ansätzen, Methoden oder Resultaten
- Publikation
- Forschungsinfrastrukturen

Wissenschaftliche Veranstaltungen

Aktiver Beitrag

Titel Art des Beitrags Titel des Artikels oder Beitrages Datum Ort Beteiligte Personen
TERMIS 2017 Vortrag im Rahmen einer Tagung Development of an injectable bioactive bulking formulation «SUINCoL» for the long-term treatment of stress urinary incontinence 26.06.2017 Davos, Schweiz Vardar Elif;


Abstract

The main goal of this project is to develop an injectable bioactive formulation, which confers initially a bulking effect as the principal action. Further it induces the regeneration of functional neo-muscle to ensure a long-term cure of urinary incontinence without scar tissue formation. The efficacy of this minimal invasive treatment will be tested in a pre-clinical mini-pig model. This bioactive formulation prototype consists of cross-linked and homogenized collagen as carrier material and fibrin micro-beads for the local and slow delivery of fibrin-binding growth factors. The fabrication method of the bioactive formulation prototype has been already developed during our CTI feasibility project (project n°18011.1PLFS-LS). Moreover, a method to produce fibrin micro-beads under non-denaturing conditions is described in more detail in our international patent application [1]. Briefly, a microfluidics platform was used to fabricate fibrin micro-beads and this method also allows covalent incorporation of growth factors to fibrin micro-beads during their production. The covalent conjugation of these growth factors to fibrin micro-beads was attained using protein-engineering tools, previously developed in our lab and improved during my PhD [2]. This project consists of two main parts. The first part of the project is to test our bioactive prototype formulation, conjugated with fibrin-binding insulin-like growth factor 1 (rIGF-1), in a clinically relevant mini-pig model and evaluate its potential to regenerate muscle. A formulation of different sizes of fibrin micro-beads incorporated into the cross-linked and homogenized collagen gels will keep rIGF-1 level elevated over a long period of time at the injection side. Thus with the slow release of IGF-1 this will trigger a functional tissue formation at the injected site. In the second part of the project, the microfluidics system will be further optimized and scaled in order to comply with the requirements for CE-mark approval. The Bridge funding will help us to test our bioactive formulation in a clinically relevant mini-pig model. This will allow us to be a step closer to CE-mark approval and clinical trials. Our active start-up project, SUINCoL, has been attracting attention from investors in the Swiss startup competition circuit [3]. As a conclusion, SUINCoL aims to incorporate at the end of the Bridge granting period. References:1. “Natural polymer-derived scaffold material and methods for production thereof" European patent application n° EP15193284.5, 2015. International patent application n°PCT/IB2016/056583, 2016.2. Vardar, Elif. “Bio-engineered collagen-fibrin scaffolds for enhancing urological tissue regeneration", PhD thesis, EPFL, 2016.3. Venture.ch: TOP5 Business idea award; TERMIS-EU Business plan competition: 1st place prize.
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