A bio-inductive collagen scaffold that supports human primary tendon-derived cell growth for rotator cuff repair

• DOI: 10.1016/j.jot.2021.10.006
• Publication Date: 2021-12-11T05:45:58Z
• Authors: Peilin Chen; Allan Wang; William Haynes; Euphemie Landao-B...; Clair Lee; Rui Ruan; William Breidahl; Behzad Shiroud He...; Christopher A. Mi...; Minghao Zheng
• Keywords: Rotator cuff injury

Rotator Cuff (RC) tendon tearing is a common clinical problem and there high incidence of revision surgery due to re-tearing. In an effort improve patient outcome reduce surgical revision, scaffolds have been widely used for augmentation RC repairs. However, little known about how support stem cell growth or facilitate regeneration. The purpose this study evaluate the structural biological properties bioactive collagen scaffold (BCS) with potential promote repair. Additionally, we conducted pilot assess safety feasibility using BCS repair tears.A series physical, ultrastructural, molecular in vitro tests determined biocompatibility teno-inductive BCS. addition, prospective case 18 patients tears (>20 ​mm diameter) was performed open-label, single-arm study, involving either mini-open arthroscopic Clinical assessment status undertaken by MRI-imaging at baseline, 6 12 months evaluated questionnaires were taken baseline as well 3, & months.The consists highly purified type-I collagen, bundles varying diameter, arranged higher order tri-laminar structure. minimal immunogenicity, being essentially DNA-free uniformly negative porcine α-Gal protein. seeded human primary tendon-derived cells exposed 6% uniaxial loading conditions vitro, supported increased levels proliferation up-regulating expression tenocyte differentiation marker genes including TNMD, Ten-C, Mohawk Collagen-1α1. To test repairs, followed IDEAL framework first, open-label single arm patients. One withdrawn from 3 wound infection unrelated remaining 17 cases showed that safe be implanted. reported encouraging improvements functional outcomes (ASES, OSS Constant-Murley scores), quality life assessments (AQoL) reduction VAS pain scores. MRI revealed complete healing 64.8% (11/17), partial thickness re-tears (17.6%) full (17.6%).The composed free immunogenic proteins supports under mechanical vitro. This shows it feasible use argumentation further controlled studies are required demonstrate its efficacy.The results indicate has unique supporting non-immunogenic. confirms promising device augment rotator cuff