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 Field | Value | Language |
---|---|---|
dc.contributor.author | Lim, Hong-Chul | - |
dc.contributor.author | Park, Yong-Beom | - |
dc.contributor.author | Ha, Chul-Won | - |
dc.contributor.author | Cole, Brian J. | - |
dc.contributor.author | Lee, Beom-Koo | - |
dc.contributor.author | Jeong, Hwa-Jae | - |
dc.contributor.author | Kim, Myung-Ku | - |
dc.contributor.author | Bin, Seong-Il | - |
dc.contributor.author | Choi, Chong-Hyuk | - |
dc.contributor.author | Choi, Choong Hyeok | - |
dc.contributor.author | Yoo, Jae-Doo | - |
dc.contributor.author | Yoon, Jung-Ro | - |
dc.contributor.author | Chung, Jun-Young | - |
dc.date.accessioned | 2022-07-07T09:20:29Z | - |
dc.date.available | 2022-07-07T09:20:29Z | - |
dc.date.created | 2021-05-11 | - |
dc.date.issued | 2021 | - |
dc.identifier.issn | 2325-9671 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/144111 | - |
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 | 영어 | - |
dc.language.iso | en | - |
dc.publisher | SAGE PUBLICATIONS INC | - |
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.contributor.affiliatedAuthor | Choi, Choong Hyeok | - |
dc.identifier.doi | 10.1177/2325967120973052 | - |
dc.identifier.scopusid | 2-s2.0-85100163344 | - |
dc.identifier.wosid | 000610098100001 | - |
dc.identifier.bibliographicCitation | ORTHOPAEDIC JOURNAL OF SPORTS MEDICINE, v.9, no.1, pp.1 - 15 | - |
dc.relation.isPartOf | ORTHOPAEDIC JOURNAL OF SPORTS MEDICINE | - |
dc.citation.title | ORTHOPAEDIC JOURNAL OF SPORTS MEDICINE | - |
dc.citation.volume | 9 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 1 | - |
dc.citation.endPage | 15 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.isOpenAccess | Y | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Orthopedics | - |
dc.relation.journalResearchArea | Sport Sciences | - |
dc.relation.journalWebOfScienceCategory | Orthopedics | - |
dc.relation.journalWebOfScienceCategory | Sport Sciences | - |
dc.subject.keywordAuthor | full-thickness cartilage defect | - |
dc.subject.keywordAuthor | cartilage restoration | - |
dc.subject.keywordAuthor | mesenchymal stem cells | - |
dc.subject.keywordAuthor | umbilical cord blood | - |
dc.subject.keywordAuthor | microfracture | - |
dc.identifier.url | https://journals.sagepub.com/doi/10.1177/2325967120973052 | - |
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.
222, Wangsimni-ro, Seongdong-gu, Seoul, 04763, Korea+82-2-2220-1365
COPYRIGHT © 2021 HANYANG UNIVERSITY.
Certain data included herein are derived from the © Web of Science of Clarivate Analytics. All rights reserved.
You may not copy or re-distribute this material in whole or in part without the prior written consent of Clarivate Analytics.