Y. Park (Seoul, KR)

Chung-Ang University Hospital, Chung-Ang University College of Medicine Department of Orhtopedic Surgery

Presenter Of 1 Presentation

Podium Presentation Stem Cells

16.1.6 - Allogeneic Umbilical Cord Blood-derived MSCs for Knee Osteoarthritis: Randomized Clinical Trial (with 5-year Follow-up Study)

Presentation Number
16.1.6
Presentation Topic
Stem Cells
Lecture Time
12:00 - 12:09
Session Name
Session Type
Free Papers
Corresponding Author
Disclosure
No Significant Commercial Relationship

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.

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