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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

 Hong-Chul Lim  ;  Yong-Beom Park  ;  Chul-Won Ha  ;  Brian J Cole  ;  Beom-Koo Lee  ;  Hwa-Jae Jeong  ;  Myung-Ku Kim  ;  Seong-Il Bin  ;  Chong-Hyuk Choi  ;  Choong Hyeok Choi  ;  Jae-Doo Yoo  ;  Jung-Ro Yoon l  ;  Jn-Young Chung 
 ORTHOPAEDIC JOURNAL OF SPORTS MEDICINE, Vol.9(1) : 2325967120973052, 2021-01 
Journal Title
Issue Date
cartilage restoration ; full-thickness cartilage defect ; mesenchymal stem cells ; microfracture ; umbilical cord blood
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/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).
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1. College of Medicine (의과대학) > Dept. of Orthopedic Surgery (정형외과학교실) > 1. Journal Papers
Yonsei Authors
Choi, Chong Hyuk(최종혁) ORCID logo https://orcid.org/0000-0002-9080-4904
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