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
Open accessAbstract
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
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In these studies on knee osteoarthritis, the control group showed no significant changes.
“whereas the control group showed no significant changes. [13]”
From Management of platelet-rich plasma and stem cells versus conventional treatments in musculoskeletal injury repair: A systematic review (2025) · cites this paper as [13]
The Results (Clinical Outcomes; page not provided) report no significant clinical improvement in the control group and no significant change in its range of motion. But the Results (Radiological Outcomes; page not provided) report a significant increase in the control group's cartilage-defect size. The unqualified statement that the control group showed no significant changes is therefore too broad. (LLM, conf=0.88)
Experimental — accuracy not yet measuredOther studies on knee osteoarthritis have shown that mesenchymal stem cells reduced WOMAC scores by 55% (P < 0.001).
“Other studies on knee OA have shown that MSCs reduced WOMAC scores by 55% ( P < 0.001)”
From Management of platelet-rich plasma and stem cells versus conventional treatments in musculoskeletal injury repair: A systematic review (2025) · cites this paper as [13]
Other studies on knee osteoarthritis have shown that mesenchymal stem cells reduced VAS pain scores by 50% (P < 0.001).
“and V AS pain scores by 50% ( P < 0.001)”
From Management of platelet-rich plasma and stem cells versus conventional treatments in musculoskeletal injury repair: A systematic review (2025) · cites this paper as [13]
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- Authors
- Lee, W.-S., Kim, H. J., Kim, K.-I., Kim, G. B., & Jin, W.
- Affiliations
- Yonsei University (KR)
- Kyung Hee University (KR)
- Kyung Hee University Hospital at Gangdong (KR)
- Corresponding author
- Kim, Kang-Il
- Venue
- Stem Cells Translational Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2019-03-05
- Volume
- 8
- Issue
- 6
- Pages
- 504-511
- ISSN
- 2157-6564 (ISSN-L)
- 2157-6580
- PMC
- PMC6525553
- OpenAlex
- W2919999424
- Cited by
- 497
- References
- 0
- Citations by year
- 2026: 46 · 2025: 73 · 2024: 81 · 2023: 89 · 2022: 83 · 2021: 74 · 2020: 44 · 2019: 6 · 2018: 1
- FWCI
- 39.64
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Stem Cells Translational Medicine (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- YUHSpace (Yonsei University Medical Library) (submittedVersion, cc-by-nc-nd)
- Topics
- Health Sciences › Medicine › Rheumatology › Osteoarthritis Treatment and Mechanisms
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cell Biology › Mesenchymal stem cell research
- Health Sciences › Dentistry › Periodontics › Periodontal Regeneration and Treatments
- Keywords
- knee osteoarthritis, adipose-derived stem cells, autologous stem cell therapy, intra-articular injection, cartilage defects, WOMAC score, analgesia, treatment safety, cartilage repair
- MeSH terms
- Adipose Tissue, Aged, Cartilage, Articular, Double-Blind Method, Female, Humans, Injections, Intra-Articular, Magnetic Resonance Imaging, Male, Middle Aged, Transplantation, Autologous, Placebo Effect, Treatment Outcome, Osteoarthritis, Knee, Mesenchymal Stem Cell Transplantation, Mesenchymal Stem Cells
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