Structural effects of intra-articular TGF-β1 in moderate to advanced knee osteoarthritis: MRI-based assessment in a randomized controlled trial
Abstract Background To 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. Methods This phase II randomized controlled trial of TG-C included patients with moderate to advanced osteoarthrit...
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| Format: | Article |
| Language: | English |
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BMC
2017-11-01
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| Series: | BMC Musculoskeletal Disorders |
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| Online Access: | http://link.springer.com/article/10.1186/s12891-017-1830-8 |
| _version_ | 1811279454901633024 |
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| author | A. Guermazi G. Kalsi J. Niu M. D. Crema R. O. Copeland A. Orlando M. J. Noh F. W. Roemer |
| author_facet | A. Guermazi G. Kalsi J. Niu M. D. Crema R. O. Copeland A. Orlando M. J. Noh F. W. Roemer |
| author_sort | A. Guermazi |
| collection | DOAJ |
| description | Abstract Background To 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. Methods This 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. Results Fifty-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. Conclusions Intraarticular 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 registration NCT01221441 .Registered 13th October, 2010 |
| first_indexed | 2024-04-13T00:54:56Z |
| format | Article |
| id | doaj.art-00b250ea9171467ab6a85e7729233eda |
| institution | Directory Open Access Journal |
| issn | 1471-2474 |
| language | English |
| last_indexed | 2024-04-13T00:54:56Z |
| publishDate | 2017-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Musculoskeletal Disorders |
| spelling | doaj.art-00b250ea9171467ab6a85e7729233eda2022-12-22T03:09:43ZengBMCBMC Musculoskeletal Disorders1471-24742017-11-011811710.1186/s12891-017-1830-8Structural effects of intra-articular TGF-β1 in moderate to advanced knee osteoarthritis: MRI-based assessment in a randomized controlled trialA. Guermazi0G. Kalsi1J. Niu2M. D. Crema3R. O. Copeland4A. Orlando5M. J. Noh6F. W. Roemer7Department of Radiology, Quantitative Imaging Center, Boston University School of MedicineTissueGeneBaylor College of MedicineDepartment of Radiology, Quantitative Imaging Center, Boston University School of MedicineTissueGeneTissueGeneTissueGeneDepartment of Radiology, Quantitative Imaging Center, Boston University School of MedicineAbstract Background To 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. Methods This 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. Results Fifty-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. Conclusions Intraarticular 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 registration NCT01221441 .Registered 13th October, 2010http://link.springer.com/article/10.1186/s12891-017-1830-8Tgf-β1OsteoarthritisMRIRandomized controlled trial |
| spellingShingle | A. Guermazi G. Kalsi J. Niu M. D. Crema R. O. Copeland A. Orlando M. J. Noh F. W. Roemer Structural effects of intra-articular TGF-β1 in moderate to advanced knee osteoarthritis: MRI-based assessment in a randomized controlled trial BMC Musculoskeletal Disorders Tgf-β1 Osteoarthritis MRI Randomized controlled trial |
| title | Structural effects of intra-articular TGF-β1 in moderate to advanced knee osteoarthritis: MRI-based assessment in a randomized controlled trial |
| title_full | Structural effects of intra-articular TGF-β1 in moderate to advanced knee osteoarthritis: MRI-based assessment in a randomized controlled trial |
| title_fullStr | Structural effects of intra-articular TGF-β1 in moderate to advanced knee osteoarthritis: MRI-based assessment in a randomized controlled trial |
| title_full_unstemmed | Structural effects of intra-articular TGF-β1 in moderate to advanced knee osteoarthritis: MRI-based assessment in a randomized controlled trial |
| title_short | Structural effects of intra-articular TGF-β1 in moderate to advanced knee osteoarthritis: MRI-based assessment in a randomized controlled trial |
| title_sort | structural effects of intra articular tgf β1 in moderate to advanced knee osteoarthritis mri based assessment in a randomized controlled trial |
| topic | Tgf-β1 Osteoarthritis MRI Randomized controlled trial |
| url | http://link.springer.com/article/10.1186/s12891-017-1830-8 |
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