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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

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dc.contributor.author최종혁-
dc.date.accessioned2021-09-29T02:08:20Z-
dc.date.available2021-09-29T02:08:20Z-
dc.date.issued2021-01-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/184732-
dc.description.abstractBackground: 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/m2), 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 cm2 in the UCB-MSC-HA group and 4.0 cm2 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.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherSage-
dc.relation.isPartOfORTHOPAEDIC JOURNAL OF SPORTS MEDICINE-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.titleAllogeneic 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.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Orthopedic Surgery (정형외과학교실)-
dc.contributor.googleauthorHong-Chul Lim-
dc.contributor.googleauthorYong-Beom Park-
dc.contributor.googleauthorChul-Won Ha-
dc.contributor.googleauthorBrian J Cole-
dc.contributor.googleauthorBeom-Koo Lee-
dc.contributor.googleauthorHwa-Jae Jeong-
dc.contributor.googleauthorMyung-Ku Kim-
dc.contributor.googleauthorSeong-Il Bin-
dc.contributor.googleauthorChong-Hyuk Choi-
dc.contributor.googleauthorChoong Hyeok Choi-
dc.contributor.googleauthorJae-Doo Yoo-
dc.contributor.googleauthorJung-Ro Yoon l-
dc.contributor.googleauthorJn-Young Chung-
dc.identifier.doi10.1177/2325967120973052-
dc.contributor.localIdA04187-
dc.relation.journalcodeJ03768-
dc.identifier.eissn2325-9671-
dc.identifier.pmid33490296-
dc.subject.keywordcartilage restoration-
dc.subject.keywordfull-thickness cartilage defect-
dc.subject.keywordmesenchymal stem cells-
dc.subject.keywordmicrofracture-
dc.subject.keywordumbilical cord blood-
dc.contributor.alternativeNameChoi, Chong Hyuk-
dc.contributor.affiliatedAuthor최종혁-
dc.citation.volume9-
dc.citation.number1-
dc.citation.startPage2325967120973052-
dc.identifier.bibliographicCitationORTHOPAEDIC JOURNAL OF SPORTS MEDICINE, Vol.9(1) : 2325967120973052, 2021-01-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Orthopedic Surgery (정형외과학교실) > 1. Journal Papers

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