First-in-Human Pilot Study of Implantation of a Scaffold-Free Tissue-Engineered Construct Generated From Autologous Synovial Mesenchymal Stem Cells for Repair of Knee Chondral Lesions
| Autor: | Norimasa Nakamura, Norihiko Sugita, Shuji Horibe, Kazunori Shimomura, Takashi Kanamoto, Yukihiko Yasui, Yu Moriguchi, Hideki Yoshikawa, Yasukazu Yonetani, Morito Sakaue, Takashi Nishii, David A. Hart, Ryota Chijimatsu, Wataru Ando, Kota Koizumi |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Male Pathology medicine.medical_specialty Scaffold Knee Joint Pilot Projects Physical Therapy Sports Therapy and Rehabilitation Articular cartilage Mesenchymal Stem Cell Transplantation Clinical study 03 medical and health sciences 0302 clinical medicine Vascularity medicine Humans Orthopedics and Sports Medicine Autografts Cartilage repair 030222 orthopedics Tissue engineered Tissue Engineering Tissue Scaffolds business.industry Synovial Membrane Mesenchymal stem cell 030229 sport sciences First in human Middle Aged Female medicine.symptom business |
| Zdroj: | The American Journal of Sports Medicine. 46:2384-2393 |
| ISSN: | 1552-3365 0363-5465 |
| DOI: | 10.1177/0363546518781825 |
| Popis: | Background: Articular cartilage has limited healing capacity, owing in part to poor vascularity and innervation. Once injured, it cannot be repaired, typically leading to high risk for developing osteoarthritis. Thus, cell-based and/or tissue-engineered approaches have been investigated; however, no approach has yet achieved safety and regenerative repair capacity via a simple implantation procedure. Purpose: To assess the safety and efficacy of using a scaffold-free tissue-engineered construct (TEC) derived from autologous synovial membrane mesenchymal stem cells (MSCs) for effective cartilage repair. Study Design: Case series; Level of evidence, 4. Methods: Five patients with symptomatic knee chondral lesions (1.5-3.0 cm2) on the medial femoral condyle, lateral femoral condyle, or femoral groove were included. Synovial MSCs were isolated from arthroscopic biopsy specimens and cultured to develop a TEC that matched the lesion size. The TECs were then implanted into chondral defects without fixation and assessed up to 24 months postoperatively. The primary outcome was the safety of the procedure. Secondary outcomes were self-assessed clinical scores, arthroscopy, tissue biopsy, and magnetic resonance image–based estimation of morphologic and compositional quality of the repair tissue. Results: No adverse events were recorded, and self-assessed clinical scores for pain, symptoms, activities of daily living, sports activity, and quality of life were significantly improved at 24 months after surgery. Secure defect filling was confirmed by second-look arthroscopy and magnetic resonance imaging in all cases. Histology of biopsy specimens indicated repair tissue approaching the composition and structure of hyaline cartilage. Conclusion: Autologous scaffold-free TEC derived from synovial MSCs may be used for regenerative cartilage repair via a sutureless and simple implantation procedure. Registration: 000008266 (UMIN Clinical Trials Registry number). |
| Databáze: | OpenAIRE |
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