Y. Park (Seoul, KR)
Chung-Ang University Hospital, Chung-Ang University College of Medicine Department of Orhtopedic SurgeryPresenter Of 1 Presentation
16.1.6 - Allogeneic Umbilical Cord Blood-derived MSCs for Knee Osteoarthritis: Randomized Clinical Trial (with 5-year Follow-up Study)
Abstract
Purpose
No current intervention leads to durable cartilage restoration in osteoarthritic knees. Our objective was to determine whether implantation of allogeneic human umbilical cord blood-derived MSCs (hUCB-MSCs)-hyaluronate composite restores cartilage in patients with symptomatic arthritic knee cartilage defects, and whether any improvements of pain and function can be maintained up to 5-years post-implantation.
Methods and Materials
A 48-week, randomized, open-label, phase 3 trial was conducted February 2009-January 2011, followed by a non-interventional extension (up to 60 months) study (June 2012-May 2015). Patients with multiple, symptomatic, full-thickness, degenerative, knee cartilage defects (International Cartilage Repair Society [ICRS] grade IV) were enrolled. The most symptomatic lesion was treated with an allogeneic hUCB-MSCs-4% hyaluronate composite (n=57) or microfracture (n=57). Primary outcome was proportion of subjects improved by ≥1 ICRS grade at 48 weeks. Secondary outcomes included histology, visual analogue scale (VAS) pain, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), International Knee Documentation Committee (IKDC) scores, surgical re-intervention rate, and adverse events.
Results
Among 114 randomized participants (age: 55.9 years), 89 completed the primary study, and 73 enrolled in the follow-up study. Mean defect size was 4.9 and 4.0 cm2 for hUCB-MSCs and microfracture, respectively. Improvement by ≥1 ICRS grade at 48 weeks was observed in 97.7% treated with hUCB-MSC versus 71.7% with microfracture (p = 0.001); and histological assessment was superior with hUCB-MSCs. VAS pain, WOMAC, and IKDC score improvements from baseline were similar between groups at 48 weeks, but were significantly better with hUCB-MSCs than microfracture by 60 months (p < 0.05). No between-group differences in surgical re-intervention rate or incidence/nature of adverse events were found.
Conclusion
hUCB-MSC implantation resulted in cartilage repair tissue in more patients and provided a robust improvement of knee pain and function than microfracture in patients with symptomatic knee osteoarthritis. hUCB-MSCscould be a therapeutic option for patients suffering from osteoarthritic cartilage defects.