Efficacy of HYADD®4-G single intra-discal injections in a rabbit model of intervertebral disc degeneration.


Journal

Bio-medical materials and engineering
ISSN: 1878-3619
Titre abrégé: Biomed Mater Eng
Pays: Netherlands
ID NLM: 9104021

Informations de publication

Date de publication:
2019
Historique:
pubmed: 10 9 2019
medline: 15 2 2020
entrez: 10 9 2019
Statut: ppublish

Résumé

Various biomaterials/technologies have been tested for treatment of intervertebral disc (IVD) degeneration (IDD). Only few non-surgical options exist. Assessment of efficacy and safety of the hyaluronic acid derivative hydrogel HYADD®4-G in IDD using a well-established rabbit annular puncture model. Rabbits were punctured at two IVDs to induce IDD. Thirty days after, IVDs were injected with HYADD®4-G or saline. IVD hydration, height, appearance and tissue organization were assessed by radiographs, MRI and histopathology. Safety of HYADD®4-G injection was evaluated in non-punctured IVDs. HYADD®4-G injection restored disc height to over 75% of the pre-punctured disc, saline injections led to 50% of initial disc height. Compared to saline, HYADD®4-G treatment resulted in improved water retention as revealed by MRI quantification. 83.3% of HYADD®4-G injected discs had normal appearance and reached grade I of the Pfirrmann scale. Regarding tissue organization and cellularity, HYADD®4-G treatment resulted in significantly lower IDD scores than saline (p < 0.01). HYADD®4-G injected into healthy IVDs did not induce inflammation or foreign body reactions. Intra-discal HYADD®4-G injection is safe and has therapeutic benefits: IDD could be limited through restoration of disc height and hydration and maintenance of normal IVD tissue organization.

Sections du résumé

BACKGROUND BACKGROUND
Various biomaterials/technologies have been tested for treatment of intervertebral disc (IVD) degeneration (IDD). Only few non-surgical options exist.
OBJECTIVE OBJECTIVE
Assessment of efficacy and safety of the hyaluronic acid derivative hydrogel HYADD®4-G in IDD using a well-established rabbit annular puncture model.
METHODS METHODS
Rabbits were punctured at two IVDs to induce IDD. Thirty days after, IVDs were injected with HYADD®4-G or saline. IVD hydration, height, appearance and tissue organization were assessed by radiographs, MRI and histopathology. Safety of HYADD®4-G injection was evaluated in non-punctured IVDs.
RESULTS RESULTS
HYADD®4-G injection restored disc height to over 75% of the pre-punctured disc, saline injections led to 50% of initial disc height. Compared to saline, HYADD®4-G treatment resulted in improved water retention as revealed by MRI quantification. 83.3% of HYADD®4-G injected discs had normal appearance and reached grade I of the Pfirrmann scale. Regarding tissue organization and cellularity, HYADD®4-G treatment resulted in significantly lower IDD scores than saline (p < 0.01). HYADD®4-G injected into healthy IVDs did not induce inflammation or foreign body reactions.
CONCLUSIONS CONCLUSIONS
Intra-discal HYADD®4-G injection is safe and has therapeutic benefits: IDD could be limited through restoration of disc height and hydration and maintenance of normal IVD tissue organization.

Identifiants

pubmed: 31498118
pii: BME191062
doi: 10.3233/BME-191062
doi:

Substances chimiques

HYADD 4 0
Hydrogels 0
Viscosupplements 0
Hyaluronic Acid 9004-61-9

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

403-417

Auteurs

Atsuya Watanabe (A)

Department of General Medical Sciences, Chiba University, Chiba, Japan.

Pierre Mainil-Varlet (P)

Aginko Research AG, Marly, Switzerland.

Adeline Decambron (A)

Université Paris-Est, Ecole Nationale Vétérinaire d'Alfort, Surgery Unit CHUVA, Maisons-Alfort Cedex, France.

Caroline Aschinger (C)

Aginko Research AG, Marly, Switzerland.

Antonella Schiavinato (A)

Fidia Farmaceutici SpA, Abano Terme, Italy.

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Classifications MeSH