Trial reportPloS one2014
A randomized clinical trial to evaluate two doses of an intra-articular injection of LMWF-5A in adults with pain due to osteoarthritis of the knee.
Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01839331 (A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Two Doses of Intra-Articular Injection of Ampion™ in Adults With Pain Due to Osteoarthritis of the Knee), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Two Doses of Intra-Articular Injection of Ampion™ in Adults With Pain Due to Osteoarthritis of the Knee
Who cites it
25 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.
- The Long-Lasting Effects of "Placebo Injections" in Knee Osteoarthritis: A Meta-Analysis.Cartilage · 2021Pooled it
- Placebo response to intra-articular injections in knee osteoarthritis: magnitude, evolution over time, and influencing factors. A systematic review and meta-analysis with meta-regression.EFORT open reviews · 2025Article
- Hydroxycitric acid reconstructs damaged articular cartilages by modifying the metabolic cascade in chondrogenic cells.Osteoarthritis and cartilage open · 2025Article
- Effects of Intra-Articular Stromal Vascular Fraction Injection on Clinical Symptoms and Cartilage Health in Osteoarthritic Knees: A Single-Center Pilot Study.Life (Basel, Switzerland) · 2024Article
- Review
- Review
- An update on the effect of intra-articular intervention strategies using nanomaterials in osteoarthritis: Possible clinical application.Frontiers in bioengineering and biotechnology · 2023Review
- Albumin as a Biomaterial and Therapeutic Agent in Regenerative Medicine.International journal of molecular sciences · 2022Review
- AMP5A modulates Toll-like receptors 7 and 8 single-stranded RNA immune responses in PMA-differentiated THP-1 and PBMC.Translational medicine communications · 2022Article
- Intra-articular placebo effect in the treatment of knee osteoarthritis: a survey of the current clinical evidence.Therapeutic advances in musculoskeletal disease · 2022Review
- LMWF5A suppresses cytokine release by modulating select inflammatory transcription factor activity in stimulated PBMC.Journal of translational medicine · 2020Article
- Autologous Mesenchymal Stem Cell Treatment is Consistently Effective for the Treatment of Knee Osteoarthritis: The Results of a Systematic Review of Treatment and Comparison to a Placebo Group.Medicines (Basel, Switzerland) · 2020Review
- Intra-articular treatment options for knee osteoarthritis.Nature reviews. Rheumatology · 2019Review
- On the Mechanisms of Action of the Low Molecular Weight Fraction of Commercial Human Serum Albumin in Osteoarthritis.Current rheumatology reviews · 2019Review
- Emerging Trend in the Pharmacotherapy of Osteoarthritis.Frontiers in endocrinology · 2019Review
- The anti-inflammatory effect of LMWF5A and N-acetyl kynurenine on macrophages: Involvement of aryl hydrocarbon receptor in mechanism of action.Biochemistry and biophysics reports · 2018Article
- Incidence of total knee replacement subsequent to intra-articular injection of the anti-inflammatory compound LMWF-5A versus saline: a long-term follow-up study to a randomized controlled trial.Patient safety in surgery · 2018Article
- Intra-articular injection of the anti-inflammatory compound LMWF-5A in adults with severe osteoarthritis: a double-blind prospective randomized controlled multi-center safety and efficacy trial.Patient safety in surgery · 2018Article
- New Drug Treatments for Osteoarthritis: What is on the Horizon?European medical journal. Rheumatology · 2017Article
- Use of Saline as a Placebo in Intra-articular Injections in Osteoarthritis: Potential Contributions to Nociceptive Pain Relief.The open rheumatology journal · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 9 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe Low Molecular Weight Fraction of 5% human serum Albumin (LMWF-5A) is being investigated as a treatment for knee pain from osteoarthritis.
methodsThis was a multicenter randomized, vehicle-controlled, double-blind, parallel study designed to evaluate the safety and efficacy of two doses of an intra-articular injection of LMWF-5A. Patients with symptomatic knee osteoarthritis were randomized 1∶1∶1∶1 to receive a single 4 mL or 10 mL intra-articular knee injection of either LMWF-5A or vehicle control (saline). The primary efficacy endpoint was the difference between treatment groups in the Western Ontario and McMaster Universities (WOMAC) pain change from baseline over 12 weeks. Safety was examined as the incidence and severity of adverse events (AEs).
resultsA total of 329 patients were randomized and received treatment. LMWF-5A resulted in a significant decrease in pain at 12 weeks compared to vehicle control (-0.93 vs -0.72; estimated difference from control: -0.25, p = 0.004); an injection volume effect was not observed (p = 0.64). The effect of LMWF-5A on pain was even more pronounced in patients with severe knee OA (Kellgren Lawrence Grade IV): the estimated difference from control was -0.42 (p = 0.02). Adverse events were generally mild and were similar in patients who received vehicle control (47%) and LMWF-5A (41%).
conclusionsThis clinical trial demonstrated that LMWF-5A is safe and effective at providing relief for the pain of moderate to severe OA of the knee over 12 weeks when administered by intra-articular injection into the knee.
trial registrationClinicalTrials.gov NCT01839331.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.