Multiple intra-articular injections of umbilical cord mesenchymal stem cells in treating severe knee osteoarthritis: a triple-blind randomized controlled trial.
5 affiliations
- 1Department of Traditional Chinese Medicine Rehabilitation, Jiangbei Branch of The First Hospital Affiliated to Army Medical University, Third Military Medical University, No. 29 Jianxin East Road, Guanyin Bridge, Jiangbei District, Chongqing, 400038, P.R. China.
- 2Department of Rehabilitation, Affiliated Hospital of Southwest Medical University, Luzhou, P. R. China.
- 3Department of Stem Cell Science, The First Hospital Affiliated to Army Medical University, (Third Military Medical University), No. 30 Gaotanyan Main Street, Shapingba District, 400038, Chongqing, P.R. China.
- 4Department of Orthopedics, Affiliated Hospital of Southwest Medical University, Luzhou, P.R. China.
- 5Department of Traditional Chinese Medicine Rehabilitation, Jiangbei Branch of The First Hospital Affiliated to Army Medical University, Third Military Medical University, No. 29 Jianxin East Road, Guanyin Bridge, Jiangbei District, Chongqing, 400038, P.R. China. [email protected].
Abstract
Background
Umbilical cord mesenchymal stem cells (UC-MSCs), with multidirectional differentiation potential, immunomodulatory properties, and paracrine repair functions, have emerged as a promising therapeutic approach for knee osteoarthritis (KOA). This study aimed to compare the 1-year clinical efficacy, structural repair, and safety of multiple intra-articular injections of UC-MSCs versus sodium hyaluronate (SH) in patients with advanced KOA (Kellgren-Lawrence grade III-IV).Methods
In this single-center, prospective, triple-blind randomized controlled trial, 50 eligible patients were randomly allocated to the UC-MSCs group (n = 25) or the SH group (n = 25). The UC-MSCs group received 4 intra-articular injections at 2-week intervals to sustain continuous paracrine effects and tissue repair, while the SH group received 5 weekly injections following its standard clinical dosing regimen. Evaluations were performed at baseline and 1, 3, 6, and 12 months post-treatment, including the visual analog scale (VAS), Western Ontario and McMaster University Osteoarthritis Index (WOMAC), Lequesne score, subjective satisfaction score, and magnetic resonance imaging (MRI)-based radiological assessments (MOCART cartilage repair score, bone marrow edema remission rate, and meniscal injury repair rate).Results
The UC-MSCs group showed a significantly greater and sustained reduction in VAS scores without rebound: the mean VAS score decreased from 7.2 ± 1.1 to 3.36 ± 0.8 at 12 months (a reduction of 3.84 ± 1.02 points), compared with a decrease from 7.0 ± 1.2 to 4.6 ± 0.9 in the SH group (a reduction of 2.42 ± 0.95 points) (P < 0.001). The 12-month WOMAC total score decreased by 23.2 ± 6.5 points in the UC-MSCs group (from 62.4 ± 8.7 to 39.2 ± 7.4), which was significantly larger than the 15.6 ± 5.8-point reduction in the SH group (from 60.8 ± 9.2 to 45.2 ± 8.1) (P < 0.05). For radiological outcomes, the mean MOCART score improved by 13.6 ± 4.2 points in the UC-MSCs group (from 18.2 ± 5.3 to 31.8 ± 6.1), versus 7.8 ± 3.5 points in the SH group (from 17.6 ± 5.1 to 25.4 ± 5.7) (P < 0.05). The remission rate of femoral bone marrow edema was 80.0% in the UC-MSCs group, significantly higher than 44.0% in the SH group (P = 0.007). No serious adverse events - defined per CTCAE v5.0 as joint infection, severe allergic reaction, tumorigenesis, or events requiring hospitalization - were observed in either group.Conclusion
Compared with SH, multiple intra-articular injections of UC-MSCs provide more durable pain relief and greater functional improvement in severe KOA, coupled with significant advantages in cartilage repair, bone marrow edema resolution, and meniscal healing. This therapy represents an innovative and effective alternative to traditional conservative management for advanced knee osteoarthritis.
Related
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BibTeX
@article{chen2026multiple,
title = {{Multiple intra-articular injections of umbilical cord mesenchymal stem cells in treating severe knee osteoarthritis: a triple-blind randomized controlled trial.}},
author = {Chang Chen and Siqi Wu and Xin Li and Xiaofei Ma and Ge Chen and Jiangjie Duan and Fuyou Wang},
journal = {Stem cell research \& therapy},
year = {2026},
month = aug,
doi = {10.1186/s13287-026-05224-w},
url = {https://europepmc.org/article/MED/42972476},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Multiple intra-articular injections of umbilical cord mesenchymal stem cells in treating severe knee osteoarthritis: a triple-blind randomized controlled trial.
AU - Chang Chen
AU - Siqi Wu
AU - Xin Li
AU - Xiaofei Ma
AU - Ge Chen
AU - Jiangjie Duan
AU - Fuyou Wang
PY - 2026
DA - 2026/08/06
JO - Stem cell research & therapy
DO - 10.1186/s13287-026-05224-w
UR - https://europepmc.org/article/MED/42972476
AB - Background Umbilical cord mesenchymal stem cells (UC-MSCs), with multidirectional differentiation potential, immunomodulatory properties, and paracrine repair functions, have emerged as a promising therapeutic approach for knee osteoarthritis (KOA). This study aimed to compare the 1-year clinical efficacy, structural repair, and safety of multiple intra-articular injections of UC-MSCs versus sodium hyaluronate (SH) in patients with advanced KOA (Kellgren-Lawrence grade III-IV).Methods In this single-center, prospective, triple-blind randomized controlled trial, 50 eligible patients were randomly allocated to the UC-MSCs group (n = 25) or the SH group (n = 25). The UC-MSCs group received 4 intra-articular injections at 2-week intervals to sustain continuous paracrine effects and tissue repair, while the SH group received 5 weekly injections following its standard clinical dosing regimen. Evaluations were performed at baseline and 1, 3, 6, and 12 months post-treatment, including the visual analog scale (VAS), Western Ontario and McMaster University Osteoarthritis Index (WOMAC), Lequesne score, subjective satisfaction score, and magnetic resonance imaging (MRI)-based radiological assessments (MOCART cartilage repair score, bone marrow edema remission rate, and meniscal injury repair rate).Results The UC-MSCs group showed a significantly greater and sustained reduction in VAS scores without rebound: the mean VAS score decreased from 7.2 ± 1.1 to 3.36 ± 0.8 at 12 months (a reduction of 3.84 ± 1.02 points), compared with a decrease from 7.0 ± 1.2 to 4.6 ± 0.9 in the SH group (a reduction of 2.42 ± 0.95 points) (P < 0.001). The 12-month WOMAC total score decreased by 23.2 ± 6.5 points in the UC-MSCs group (from 62.4 ± 8.7 to 39.2 ± 7.4), which was significantly larger than the 15.6 ± 5.8-point reduction in the SH group (from 60.8 ± 9.2 to 45.2 ± 8.1) (P < 0.05). For radiological outcomes, the mean MOCART score improved by 13.6 ± 4.2 points in the UC-MSCs group (from 18.2 ± 5.3 to 31.8 ± 6.1), versus 7.8 ± 3.5 points in the SH group (from 17.6 ± 5.1 to 25.4 ± 5.7) (P < 0.05). The remission rate of femoral bone marrow edema was 80.0% in the UC-MSCs group, significantly higher than 44.0% in the SH group (P = 0.007). No serious adverse events - defined per CTCAE v5.0 as joint infection, severe allergic reaction, tumorigenesis, or events requiring hospitalization - were observed in either group.Conclusion Compared with SH, multiple intra-articular injections of UC-MSCs provide more durable pain relief and greater functional improvement in severe KOA, coupled with significant advantages in cartilage repair, bone marrow edema resolution, and meniscal healing. This therapy represents an innovative and effective alternative to traditional conservative management for advanced knee osteoarthritis.
SN - 1757-6512
ER -