Intra‐Articular Injection of Autologous Adipose Tissue‐Derived Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis: A Phase IIb, Randomized, Placebo‐Controlled Clinical Trial

Mesenchymal stem cells (MSCs) have been the focus of an emerging treatment for osteoarthritis. However, few studies reported about outcomes of an intra‐articular injection of autologous adipose‐derived mesenchymal stem cells (AD‐MSCs). This study aimed to assess the efficacy and safety of a single i...

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Veröffentlicht in:Stem cells translational medicine Jg. 8; H. 6; S. 504 - 511
Hauptverfasser: Lee, Woo‐Suk, Kim, Hwan Jin, Kim, Kang‐Il, Kim, Gi Beom, Jin, Wook
Format: Journal Article
Sprache:Englisch
Veröffentlicht: Hoboken, USA John Wiley & Sons, Inc 01.06.2019
Oxford University Press
Schlagworte:
Adipose tissue
Adipose Tissue - cytology
Adipose‐derived mesenchymal stem cell
Aged
Analgesics
Arthritis
Autografts
Body fat
Cartilage diseases
Cartilage, Articular - diagnostic imaging
Clinical trials
Double-Blind Method
Drug dosages
FDA approval
Female
Human Clinical
Humans
Injection
Injections, Intra-Articular
Intra‐articular injection
Knee
Laboratories
Magnetic Resonance Imaging
Male
Mesenchymal Stem Cell Transplantation - adverse effects
Mesenchymal stem cells
Mesenchymal Stem Cells - cytology
Mesenchymal Stem Cells - metabolism
Mesenchyme
Middle Aged
NMR
Nuclear magnetic resonance
Osteoarthritis
Osteoarthritis, Knee - pathology
Osteoarthritis, Knee - therapy
Outpatient care facilities
Pain
Patients
Placebo Effect
Stem cells
Studies
Transplantation, Autologous
Treatment Outcome
United States > US
Knee
Intra-articular injection
Adipose-derived mesenchymal stem cell
Osteoarthritis
ISSN:2157-6564, 2157-6580, 2157-6580
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Zusammenfassung:Mesenchymal stem cells (MSCs) have been the focus of an emerging treatment for osteoarthritis. However, few studies reported about outcomes of an intra‐articular injection of autologous adipose‐derived mesenchymal stem cells (AD‐MSCs). This study aimed to assess the efficacy and safety of a single intra‐articular injection of AD‐MSCs for patients with knee osteoarthritis. It was a prospective double‐blinded, randomized controlled, phase IIb clinical trial. AD‐MSCs were administered for 12 patients (MSC group), and the group was compared with 12 knees with injection of normal saline (control group) up to 6 months. All procedures were performed in the outpatient clinic. Primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) score. Secondary outcome measure included various clinical and radiologic examination, and safety after injection. Change of cartilage defect after injection was evaluated using magnetic resonance imaging (MRI). Single injection of AD‐MSCs led to a significant improvement of the WOMAC score at 6 months. In the control group, there was no significant change in the WOMAC score at 6 months. No serious adverse events were observed in both groups during the follow‐up period. In MRI, there was no significant change of cartilage defect at 6 months in MSC group whereas the defect in the control group was increased. An intra‐articular injection of autologous AD‐MSCs provided satisfactory functional improvement and pain relief for patients with knee osteoarthritis in the outpatient setting, without causing adverse events at 6 months' follow‐up. Larger sample size and long‐term follow‐up are required. Stem Cells Translational Medicine 2019;8:504–511 Autologous adipose‐derived mesenchymal stem cells (AD‐MSCs) were administered for 12 patients, and the group was compared with 12 knees with injection of normal saline up to 6 months. The procedures were performed in an outpatient clinic. An intra‐articular injection of autologous AD‐MSCs provided satisfactory functional improvement and pain relief in patients with knee osteoarthritis without causing adverse events at 6 months' follow‐up.
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SourceType-Scholarly Journals-1
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ObjectType-Evidence Based Healthcare-1
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ISSN:2157-6564
2157-6580
2157-6580
DOI:10.1002/sctm.18-0122