The Use of Mesenchymal Stem Cells in Orthopedics: Review of the Literature, Current Research, and Regulatory Landscape

摘要

Mesenchymal stem cells (MSCs) show promising clinicalpotential as multi-potent therapeutic agents in regenerativemedicine, including a number of orthopedic applications. Acomprehensive review of the medical literature regarding thepre-clinical and early clinical use of MSCs demonstrates that theyare likely to be effective cellular repair agents for cartilage andjoint injuries.Cultured MSCs were injected into the knee joints of 153patients with moderate to severe osteoarthritis (OA) of the knee.The study included 24 untreated patient candidates who wererecruited as controls. At a mean follow-up of 11.3 months, kneepatients reported mean pain relief as +53.1% (n=133), and -5.0%relief was found in the untreated control (n=25 at 12.0 monthspost-op) ( <.001 for control vs. knee comparison). Significantdecreases were seen in four out of five of the Visual Analog Scale(VAS) score metrics and in most functional metrics in the kneegroup.Therewerenoserious complications reported.MSCs may reduce the need for joint replacement in kneeosteoarthritis. Despite the great potential of the use ofautologous MSCs as the practice of medicine, the Food and DrugAdministration (FDA) has attempted to regulate MSCs as a drug.This policy is inconsistent with its policy on other mattersincluding tissue re-implantation and in vitro fertilization, and willdelay thedevelopmentof this typeof therapy.