Trial reportBMC musculoskeletal disorders2017
Structural effects of intra-articular TGF-β1 in moderate to advanced knee osteoarthritis: MRI-based assessment in a randomized controlled trial.
Trial report in BMC musculoskeletal disorders, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01221441 (A Phase II Study to Determine the Efficacy and Safety of Allogeneic Human Chondrocytes Expressing TGF-β1), which is not on this map. Cited by 21 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 Phase II Study to Determine the Efficacy and Safety of Allogeneic Human Chondrocytes Expressing TGF-β1 (TissueGene-C) in Patients With Grade 3 Chronic Degenerative Joint Disease of the Knee
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.
- Pooled it
- The promising potential of intra-articular losartan combined with scaffold implantation for osteochondral repair: a comparative study in a rabbit model against osteochondral autograft transplantation.Journal of experimental orthopaedics · 2025Article
- Imaging of osteoarthritis-related bone marrow lesions in clinical trials.Osteoarthritis imaging · 2025Article
- Imaging-based measures of synovitis in knee osteoarthritis: A scoping review and narrative synthesis.Osteoarthritis and cartilage open · 2025Review
- Which Endpoints Should be Applied in Interventional Trials? -: From Single Uni-dimensional Assessment Tailored to a Drug's Mechanism of Action to Multi-Component Measures and Multi-Domain Composites.Osteoarthritis imaging · 2025Article
- Advances and Challenges in the Pursuit of Disease-Modifying Osteoarthritis Drugs: A Review of 2010-2024 Clinical Trials.Biomedicines · 2025Review
- Review
- Joint interventions in osteoarthritis.Skeletal radiology · 2023Review
- Latest insights in disease-modifying osteoarthritis drugs development.Therapeutic advances in musculoskeletal disease · 2023Review
- Strategic application of imaging in DMOAD clinical trials: focus on eligibility, drug delivery, and semiquantitative assessment of structural progression.Therapeutic advances in musculoskeletal disease · 2023Review
- How Effective Are Non-Operative Intra-Articular Treatments for Bone Marrow Lesions in Knee Osteoarthritis in Adults? A Systematic Review of Controlled Clinical Trials.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Repurposed and investigational disease-modifying drugs in osteoarthritis (DMOADs).Therapeutic advances in musculoskeletal disease · 2022Review
- Cross-sectional and longitudinal reliability of semiquantitative osteoarthritis assessment at 1.0T extremity MRI: Multi-reader data from the MOST study.Osteoarthritis and cartilage open · 2021Article
- Article
- Targeting Cartilage Degradation in Osteoarthritis.Pharmaceuticals (Basel, Switzerland) · 2021Review
- Immunological Events, Emerging Pharmaceutical Treatments and Therapeutic Potential of Balneotherapy on Osteoarthritis.Frontiers in pharmacology · 2021Article
- The Development of Disease-Modifying Therapies for Osteoarthritis (DMOADs): The Evidence to Date.Drug design, development and therapy · 2021Review
- Current Applications of Growth Factors for Knee Cartilage Repair and Osteoarthritis Treatment.Current reviews in musculoskeletal medicine · 2020Review
- Emerging pharmaceutical therapies for osteoarthritis.Nature reviews. Rheumatology · 2020Review
- Intra-articular treatment options for knee osteoarthritis.Nature reviews. Rheumatology · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTo determine effects of allogeneic human chondrocytes expressing TGF-β1 (TG-C) on structural progression of MRI features of knee osteoarthritis over a 1 year period.
methodsThis phase II randomized controlled trial of TG-C included patients with moderate to advanced osteoarthritis. Patients were randomized to receive an intraarticular 3:1 mixture of non-transduced allogeneic human chondrocytes and TG-C or placebo. 3 T MRI was acquired for all patients at baseline and follow-up (3, 6 and 12 months). MRIs were assessed using the WORMS system including cartilage damage, bone marrow lesions (BMLs), meniscal damage/extrusion, Hoffa-, effusion-synovitis, and osteophytes. Analyses were performed on a whole knee level, compartmental level, and subregional level. Binary logistic regression with Generalized Estimating Equation was used to compare risks of progression, adjusting for baseline age and gender. Mann - Whitney - Wilcoxon tests were used to assess differences for continuous variables.
resultsFifty-seven Patients were included in the TG-C group and 29 in the placebo group. At 12 months, knees in the TG-C group showed less progression of cartilage damage compared to placebo on a whole knee level (34.6% vs. 47.9%; adjusted RR 0.7, 95%CI [0.5-1.1], p = 0.077). Less progression of Hoffa-synovitis and effusion-synovitis was observed in the TG-C group compared to placebo (9.6% vs. 21.1%, adjusted RR 0.5, 95%CI [0.2,1.2], p = 0.115). No statistically significant differences were seen for BMLs, meniscal damage and osteophytes.
conclusionsIntraarticular treatment with TG-C showed fewer patients in the treated group with progression in structural OA features and other MRI-defined inflammatory markers such as Hoffa-synovitis and effusion-synovitis. However, no differences were observed in regard to progression of BMLs and meniscal damage, or hypertrophic osteophyte formation.
trial registrationNCT01221441 .Registered 13th October, 2010.
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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.