Full metadata record
DC Field | Value | Language |
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dc.contributor.author | 유재두 | * |
dc.date.accessioned | 2021-02-18T16:30:35Z | - |
dc.date.available | 2021-02-18T16:30:35Z | - |
dc.date.issued | 2021 | * |
dc.identifier.issn | 2325-9671 | * |
dc.identifier.other | OAK-28816 | * |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/256983 | - |
dc.description.abstract | Background: There is currently no optimal method for cartilage restoration in large, full-thickness cartilage defects in older patients. Purpose: To determine whether implantation of a composite of allogeneic umbilical cord blood-derived mesenchymal stem cells and 4% hyaluronate (UCB-MSC-HA) will result in reliable cartilage restoration in patients with large, full-thickness cartilage defects and whether any clinical improvements can be maintained up to 5 years postoperatively. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A randomized controlled phase 3 clinical trial was conducted for 48 weeks, and the participants then underwent extended 5-year observational follow-up. Enrolled were patients with large, full-thickness cartilage defects (International Cartilage Repair Society [ICRS] grade 4) in a single compartment of the knee joint, as confirmed by arthroscopy. The defect was treated either with UCB-MSC-HA implantation through mini-arthrotomy or with microfracture. The primary outcome was proportion of participants who improved by >= 1 grade on the ICRS Macroscopic Cartilage Repair Assessment (blinded evaluation) at 48-week arthroscopy. Secondary outcomes included histologic assessment; changes in pain visual analog scale (VAS) score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and International Knee Documentation Committee (IKDC) score from baseline; and adverse events. Results: Among 114 randomized participants (mean age, 55.9 years; 67% female; body mass index, 26.2 kg/m(2)), 89 completed the phase 3 clinical trial and 73 were enrolled in the 5-year follow-up study. The mean defect size was 4.9 cm(2) in the UCB-MSC-HA group and 4.0 cm(2) in the microfracture group (P = .051). At 48 weeks, improvement by >= 1 ICRS grade was seen in 97.7% of the UCB-MSC-HA group versus 71.7% of the microfracture group (P = .001); the overall histologic assessment score was also superior in the UCB-MSC-HA group (P = .036). Improvement in VAS pain, WOMAC, and IKDC scores were not significantly different between the groups at 48 weeks, however the clinical results were significantly better in the UCB-MSC-HA group at 3- to 5-year follow-up (P < .05). There were no differences between the groups in adverse events. Conclusion: In older patients with symptomatic, large, full-thickness cartilage defects with or without osteoarthritis, UCB-MSC-HA implantation resulted in improved cartilage grade at second-look arthroscopy and provided more improvement in pain and function up to 5 years compared with microfracture. Registration: NCT01041001, NCT01626677 (ClinicalTrials.gov identifier). | * |
dc.language | English | * |
dc.publisher | SAGE PUBLICATIONS INC | * |
dc.subject | full-thickness cartilage defect | * |
dc.subject | cartilage restoration | * |
dc.subject | mesenchymal stem cells | * |
dc.subject | umbilical cord blood | * |
dc.subject | microfracture | * |
dc.title | Allogeneic Umbilical Cord Blood-Derived Mesenchymal Stem Cell Implantation Versus Microfracture for Large, Full-Thickness Cartilage Defects in Older Patients: A Multicenter Randomized Clinical Trial and Extended 5-Year Clinical Follow-up | * |
dc.type | Article | * |
dc.relation.issue | 1 | * |
dc.relation.volume | 9 | * |
dc.relation.index | SCIE | * |
dc.relation.index | SCOPUS | * |
dc.relation.journaltitle | ORTHOPAEDIC JOURNAL OF SPORTS MEDICINE | * |
dc.identifier.doi | 10.1177/2325967120973052 | * |
dc.identifier.wosid | WOS:000610098100001 | * |
dc.author.google | Lim, Hong-Chul | * |
dc.author.google | Park, Yong-Beom | * |
dc.author.google | Ha, Chul-Won | * |
dc.author.google | Cole, Brian J. | * |
dc.author.google | Lee, Beom-Koo | * |
dc.author.google | Jeong, Hwa-Jae | * |
dc.author.google | Kim, Myung-Ku | * |
dc.author.google | Bin, Seong-Il | * |
dc.author.google | Choi, Chong-Hyuk | * |
dc.author.google | Choi, Choong Hyeok | * |
dc.author.google | Yoo, Jae-Doo|Cartistem Res Grp | * |
dc.contributor.scopusid | 유재두(16641404300) | * |
dc.date.modifydate | 20240118131633 | * |