Randomized control trial of mesenchymal stem cells versus hyaluronic acid in patients with knee osteoarthritis – A Hong Kong pilot study
Objective: This pilot study evaluated the efficacy of autologous bone marrow-derived mesenchymal stem cells (BM-MSCs) versus hyaluronic acid (HA) in surgically naïve patients with knee osteoarthritis (OA). Methods: Single-centre, single-blind randomized study of patients with knee OA. Twenty patient...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-11-01
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| Series: | Journal of Orthopaedic Translation |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2214031X22000730 |
| _version_ | 1828071563626283008 |
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| author | Kevin Ki-wai Ho Wayne Yuk-wai Lee James F. Griffith Michael Tim-yun Ong Gang Li |
| author_facet | Kevin Ki-wai Ho Wayne Yuk-wai Lee James F. Griffith Michael Tim-yun Ong Gang Li |
| author_sort | Kevin Ki-wai Ho |
| collection | DOAJ |
| description | Objective: This pilot study evaluated the efficacy of autologous bone marrow-derived mesenchymal stem cells (BM-MSCs) versus hyaluronic acid (HA) in surgically naïve patients with knee osteoarthritis (OA). Methods: Single-centre, single-blind randomized study of patients with knee OA. Twenty patients were randomized into groups of 10 each for intra-articular injection of cultured BM-MSCs (6 ml of BM-MSCs at 1 × 106 cells/mL) or HA (6 ml). Clinical assessments of pain, quality of life, radiographic imaging, and magnetic resonance imaging (MRI) compositional change were performed at baseline and 12 months follow-up. Results: Compared with HA, BM-MSCs injection resulted in significant improvement in qualify of life and reduction in pain as reflected by visual analogue scale (VAS) pain score, Western Ontario and McMaster Universities Arthritis Index (WOMAC) score, and 36-Item Short Form Survey (SF-36) score collectively. T2-relaxation time tended to decrease more in the BM-MSCs group with a 38 ± 24.0% reduction in 6 out of 10 BM-MSC participants; while there was only a 12 ± 7.9% reduction in 4 out of 10 HA participants at the end of follow-up. The remaining participants showed either no response or had relaxation time increased on MRI assessment. Conclusions: This pilot study found that autologous BM-MSCs significantly reduced pain, improved functional assessment score, and improved quality of life parameters comparing with HA at one year follow-up. Further clinical trial with larger sample size and longer follow up duration is warranted. The Translational Potential of this Article: This pilot RCT demonstrated the feasibility and potential effectiveness of BM-MSCs advanced therapy for patients with knee OA compared to HA injection. Further multi-center clinical trial with a larger sample size and longer follow up duration in accordance with latest regulatory guidelines is warranted to ascertain the long term safety and effectiveness of MSCs therapy for cartilage regeneration in OA. Registration: The study was registered in the Centre for Clinical Research Biostatistics - Clinical Trials Registry (CUHK_CCT00469). |
| first_indexed | 2024-04-11T00:54:59Z |
| format | Article |
| id | doaj.art-ef8f6df7aa644f56a61c302b0961da54 |
| institution | Directory Open Access Journal |
| issn | 2214-031X |
| language | English |
| last_indexed | 2024-04-11T00:54:59Z |
| publishDate | 2022-11-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of Orthopaedic Translation |
| spelling | doaj.art-ef8f6df7aa644f56a61c302b0961da542023-01-05T06:24:05ZengElsevierJournal of Orthopaedic Translation2214-031X2022-11-01376977Randomized control trial of mesenchymal stem cells versus hyaluronic acid in patients with knee osteoarthritis – A Hong Kong pilot studyKevin Ki-wai Ho0Wayne Yuk-wai Lee1James F. Griffith2Michael Tim-yun Ong3Gang Li4Department of Orthopaedics & Traumatology, Faculty of Medicine, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, China; Corresponding author. Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Shatin, Hong Kong, China.Department of Orthopaedics & Traumatology, Faculty of Medicine, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, China; Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, ChinaDepartment of Imaging and Interventional Radiology, Faculty of Medicine, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, ChinaDepartment of Orthopaedics & Traumatology, Faculty of Medicine, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, ChinaDepartment of Orthopaedics & Traumatology, Faculty of Medicine, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, China; Lui Che Woo Institute of Innovative Medicine, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, China; Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, China; Corresponding author. Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Shatin, Hong Kong, China.Objective: This pilot study evaluated the efficacy of autologous bone marrow-derived mesenchymal stem cells (BM-MSCs) versus hyaluronic acid (HA) in surgically naïve patients with knee osteoarthritis (OA). Methods: Single-centre, single-blind randomized study of patients with knee OA. Twenty patients were randomized into groups of 10 each for intra-articular injection of cultured BM-MSCs (6 ml of BM-MSCs at 1 × 106 cells/mL) or HA (6 ml). Clinical assessments of pain, quality of life, radiographic imaging, and magnetic resonance imaging (MRI) compositional change were performed at baseline and 12 months follow-up. Results: Compared with HA, BM-MSCs injection resulted in significant improvement in qualify of life and reduction in pain as reflected by visual analogue scale (VAS) pain score, Western Ontario and McMaster Universities Arthritis Index (WOMAC) score, and 36-Item Short Form Survey (SF-36) score collectively. T2-relaxation time tended to decrease more in the BM-MSCs group with a 38 ± 24.0% reduction in 6 out of 10 BM-MSC participants; while there was only a 12 ± 7.9% reduction in 4 out of 10 HA participants at the end of follow-up. The remaining participants showed either no response or had relaxation time increased on MRI assessment. Conclusions: This pilot study found that autologous BM-MSCs significantly reduced pain, improved functional assessment score, and improved quality of life parameters comparing with HA at one year follow-up. Further clinical trial with larger sample size and longer follow up duration is warranted. The Translational Potential of this Article: This pilot RCT demonstrated the feasibility and potential effectiveness of BM-MSCs advanced therapy for patients with knee OA compared to HA injection. Further multi-center clinical trial with a larger sample size and longer follow up duration in accordance with latest regulatory guidelines is warranted to ascertain the long term safety and effectiveness of MSCs therapy for cartilage regeneration in OA. Registration: The study was registered in the Centre for Clinical Research Biostatistics - Clinical Trials Registry (CUHK_CCT00469).http://www.sciencedirect.com/science/article/pii/S2214031X22000730Knee osteoarthritisHyaluronic acidBone marrow derived mesenchymal stem cellsIntra-articular injectionClinical trial |
| spellingShingle | Kevin Ki-wai Ho Wayne Yuk-wai Lee James F. Griffith Michael Tim-yun Ong Gang Li Randomized control trial of mesenchymal stem cells versus hyaluronic acid in patients with knee osteoarthritis – A Hong Kong pilot study Journal of Orthopaedic Translation Knee osteoarthritis Hyaluronic acid Bone marrow derived mesenchymal stem cells Intra-articular injection Clinical trial |
| title | Randomized control trial of mesenchymal stem cells versus hyaluronic acid in patients with knee osteoarthritis – A Hong Kong pilot study |
| title_full | Randomized control trial of mesenchymal stem cells versus hyaluronic acid in patients with knee osteoarthritis – A Hong Kong pilot study |
| title_fullStr | Randomized control trial of mesenchymal stem cells versus hyaluronic acid in patients with knee osteoarthritis – A Hong Kong pilot study |
| title_full_unstemmed | Randomized control trial of mesenchymal stem cells versus hyaluronic acid in patients with knee osteoarthritis – A Hong Kong pilot study |
| title_short | Randomized control trial of mesenchymal stem cells versus hyaluronic acid in patients with knee osteoarthritis – A Hong Kong pilot study |
| title_sort | randomized control trial of mesenchymal stem cells versus hyaluronic acid in patients with knee osteoarthritis a hong kong pilot study |
| topic | Knee osteoarthritis Hyaluronic acid Bone marrow derived mesenchymal stem cells Intra-articular injection Clinical trial |
| url | http://www.sciencedirect.com/science/article/pii/S2214031X22000730 |
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