Intra-articular injection of umbilical cord–derived mesenchymal stem cells is safe and effective for moderate to severe knee osteoarthritis with synovitis: a double‑blinded and randomized controlled trial
Bibliographic record
Abstract
OBJECTIVES: To evaluate the safety and clinical efficacy of intra-articular injection of human umbilical cord–derived mesenchymal stem cells (UC-MSCs) for knee osteoarthritis (KOA). METHODS: This was a randomized, double-blind, placebo-control trial consisting of 3 arms including placebo, hyaluronic acid (HA), and UC-MSCs. 69 individuals were screened, with 55 participants subsequently randomized. The primary endpoint was the safety after injection. The secondary endpoints were improvements in visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Society Clinical Rating System (KSS), EuroQol five-dimensional questionnaire (EQ-5D), and magnetic resonance imaging (MRI) examinations at 6-month after injection. RESULTS: Adverse events (AEs) did not demonstrate significant differences among the groups. No serious treatment-related AEs were observed. Compared with placebo and HA, injection of UC-MSCs resulted in a greater improvement in VAS and EQ-5D; however, the differences were not statistically significant. Patients in the UC-MSCs group exhibited significant improvement in synovitis at the 6-month follow-up as compared with the placebo and HA groups (P = 0.003). At 6 months, UC-MSCs injection showed significantly better improvements in VAS (P = 0.011), WOMAC (P = 0.014), and EQ-5D scores (P = 0.049) in patients with KOA incorporating synovitis, particularly those experiencing moderate to severe pain. MRI indicated no significant difference in change of joint structures among the groups, except for the synovium. CONCLUSIONS: Treatment with UC-MSCs was shown to be a viable therapeutic option for KOA combined with synovitis, showing clinical improvement at the end of follow-up, especially in those with moderate to severe pain. Further phase III clinical trials would be required to confirm the efficacy. TRIAL REGISTRATION: The trial was registered at chictr.org on October 13, 2020, with the registration number ChiCTR2000039017.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".