Results of a Phase II Study to Determine the Efficacy and Safety of Genetically Engineered Allogeneic Human Chondrocytes Expressing TGF- β1

J Knee Surg DOI: 10.1055/s-0038-1676803Genetically engineered chondrocytes virally transduced with a transforming growth factor (TGF)-β1 (TG-C [TissueGene-C]) expression vector have been shown to have potential benefits in the nonoperative management of knee osteoarthritis. Previous literature has reported on safe dosages of TG-C. Therefore, the purpose of this study was to evaluate the Phase II results and a 24-month efficacy of this injectable mixture compared with placebo in patients with Kellgren–Lawrence (K–L) grade III knee osteoarthritis. Specifically, we assessed (1) functional outcomes, (2) pain scores, (3) adverse events (AEs), and (4) magnetic resonance imaging (MRIs) findings. We performed a multicenter, double-blinded, placebo-controlled, and randomized study of adults who had K–L grade III knee osteoarthritis. A total of 102 patients were 2:1 randomized to TG-C at a dose of 3.0 × 107 cells, or placebo injections between May 1, 2011 and October 31, 2012. Outcomes analyzed were knee joint function, pain, quality of life, adverse events, and MRI findings using the whole-organ magnetic resonance imaging score (WORMS) system. There were significant improvements in the International Knee Documentation Committee (IKDC) and visual analogue scale (VAS) scores in the TG-C cohort, when compared with the placebo cohort at weeks 12, 52, 72, and 104 (p 
Source: Journal of Knee Surgery - Category: Orthopaedics Authors: Tags: Original Article Source Type: research

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CONCLUSION: Autologous ADMSC therapy appears to be a safe and effective therapy for knee osteoarthritis and may have the potential to prevent disease progression. TRIAL REGISTRATION NUMBER: ACTRN12614000814673. PMID: 30762487 [PubMed - as supplied by publisher]
Source: Regenerative Medicine - Category: Genetics & Stem Cells Authors: Tags: Regen Med Source Type: research
This study will focus on detecting the cerebral functional connectivity changes elicited by acupuncture treatment. The Visual Analog Scale and the short form of the McGill Pain Questionnaire, the Western Ontario and McMaster Universities Osteoarthritis Index, the Attention Test Scale, the Pain Assessment of Sphygmomanometer and the 12-Item Short Form Health Survey will be used to evaluate the symptoms and quality of life improvement at the baseline and the end of treatment. The Self-rating Anxiety Scale and the Self-rating Depression Scale will be used at the baseline and the end of treatment to investigate the influence o...
Source: Trials - Category: Research Source Type: clinical trials
Publication date: Available online 27 March 2018Source: Orthopaedics &Traumatology: Surgery &ResearchAuthor(s): Pierre-Louis Docquier, Pierre Maldaque, Maryse BouchardAbstractTarsal coalition is due to failure of segmentation between two or more foot bones during embryological development at a site where the joint cleft fails to develop. Depending on the nature of the tissue connecting the bones, the abnormality is a syndesmosis, synchondrosis, or synostosis. Although the coalition exists at birth, synostosis usually develops only late during growth. Talo-calcaneal and calcaneo-navicular coalitions account for over...
Source: Orthopaedics and Traumatology: Surgery and Research - Category: Orthopaedics Source Type: research
DiscussionThis will be the first study to compare a targeted gluteal rehabilitation programme to a sham exercise programme. The targeted GHOst programme includes exercises designed to address gait impairments as well as gluteal-muscle atrophy and dysfunction.Trial registrationAustralian New Zealand Clinical Trials Registry, ID:ACTRN12617000970347. Registered retrospectively on 5 July 2017. Protocol version 3.0.
Source: Trials - Category: Research Source Type: clinical trials
Authors: Riis RG Abstract Knee osteoarthritis (KOA) is one of the most common causes of physical disability in the elderly population. With an increasing ageing and obese population, the prevalence of KOA is expected to rise substantially. The needs for a better understanding of the disease and tools that can predict the course of the disease, for example following treatment, are therefore imperative. 

Inflammation has over the last years been recognised as an important factor for both the symptomatology and disease course in KOA. Synovitis, inflammation of the synovium, is the hallmark of intra-articular infl...
Source: Danish Medical Journal - Category: General Medicine Tags: Dan Med J Source Type: research
AbstractPurpose of ReviewFibromyalgia (FM) is the second most common rheumatologic pain disorder after osteoarthritis with a multisystem presentation. While the treatment of FM in a clinical setting incorporates both pharmacologic and non-pharmacologic modalities, the present investigation reviews evolving literature on cognitive behavioral and complementary medical therapies. The recent medical literature on FM was reviewed between 2012 and 2017 via MEDLINE and the Cochrane Central Registry of Controlled Trials, with an emphasis on randomized controlled trials, meta-analyses, and evidence-based treatment guidelines.Recent...
Source: Current Pain and Headache Reports - Category: Neurology Source Type: research
Publication date: Available online 27 March 2018 Source:Orthopaedics & Traumatology: Surgery & Research Author(s): P.-L. Docquier, P. Maldaque, M. Bouchard Tarsal coalition is due to failure of segmentation between two or more foot bones during embryological development at a site where the joint cleft fails to develop. Depending on the nature of the tissue connecting the bones, the abnormality is a syndesmosis, synchondrosis, or synostosis. Although the coalition exists at birth, synostosis usually develops only late during growth. Talo-calcaneal and calcaneo-navicular coalitions account for over 90% of all cases ...
Source: Orthopaedics and Traumatology: Surgery and Research - Category: Orthopaedics Source Type: research
Abstract Bucket-handle meniscal tears are extremely rare injuries in the pediatric population. Given the known sequelae of meniscal tears and the development of osteoarthritis, early diagnosis and treatment of pediatric meniscal tears are essential. The communication barrier between physicians and pediatric patients, however, creates difficulties in making the correct diagnosis of meniscal pathology. Providers should have a low threshold for obtaining further confirmatory advanced imaging if patients present with prolonged knee pain and swelling, with associated locking mechanical symptoms. Good clinical outcomes ...
Source: Orthopedics - Category: Orthopaedics Authors: Tags: Orthopedics Source Type: research
Conclusions Transcatheter arterial embolization significantly improved pain symptoms and clinical function in patients with mild to moderate knee OA that was resistant to conservative treatment.
Source: Journal of Vascular and Interventional Radiology - Category: Radiology Source Type: research
This study examined the relationship between clinical and functional markers of localised knee inflammation and CE MRI based synovial scores. Methods Patients with symptomatic KOA were enrolled into the randomised, double‐blind, Vitamin D Evaluation in Osteoarthritis (VIDEO) trial. In this cross‐sectional substudy, associations between validated MRI based semi‐quantitative synovial scores of the knee and the following markers of inflammation were investigated; self‐reported pain and stiffness, effusion, warmth, joint line tenderness, erythrocyte sedimentation rate, radiographic severity and functional ability tests...
Source: Arthritis Care and Research - Category: Rheumatology Authors: Tags: Original Article Source Type: research
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