Regeneration of Meniscal Cartilage with Use of a Collagen Scaffold. Analysis of Preliminary Data

ABSTRACT: A collagen scaffold was designed for use as a template for the regeneration of meniscal cartilage and was tested in ten patients in an initial, Food and Drug Administration-approved, clinical fea-sibility trial. The goal of the study was to evaluate the implantability and safety of the scaffold as well as its ability to support tissue ingrowth. The study was based on the findings of in vitro and in vivo investi-gations in dogs that had demonstrated cellular in-growth and tissue regeneration through the scaffold. Nine patients remained in the study for at least thirty-six months, and one patient voluntarily withdrew after three months for personal reasons. The collagen scaffold was found to be implantable and to be safe over the three-year period. Histologi-cally, it supported regeneration of tissue in meniscal defects of various sizes. No adverse immunological re-actions were noted on sequential serological testing. On second-look arthroscopy, performed either three or six months after implantation, gross and histologi-cal evaluation revealed newly formed tissue replacing the implant as it was resorbed. At thirty-six months, the nine patients reported a decrease in the symp-toms. According to a scale that assigned 1 point for strenuous activity and 5 points for an inability to per-form sports activity, the average score was 1.5 points before the injury, 3.0 points after the injury and be-fore the operation, and 2.4 points at six months post-operatively, 2.2 points at twelve months, 2.0 points at twenty-four months, and 1.9 points at thirty-six months. According to a scale that assigned 0 points for no pain and 3 points for severe pain, the average *One or more of the authors has received or will receive bene-fits for personal or professional use from a commercial party related directly or indirectly to the subject of this article. Funds were re-ceived in total or partial support of the research or clinical study presented in this article. The funding source was ReGen Biologies