Preliminary results of a phase II randomized study to determine the efficacy and safety of genetically engineered allogeneic human chondrocytes expressing TGF-β1 in patients with grade 3 chronic degenerative joint disease of the knee

SummaryObjectiveThe aim of this study was to preliminarily evaluate the efficacy and outcomes of injectable genetically engineered chondrocytes virally transduced with TGF-β1 (GEC-TGF-β1) compared to placebo.DesignA multi-center, double-blinded, placebo-controlled, randomized study of adults with knee osteoarthritis. A total of 102 patients were 2:1 randomized to GEC-TGF-β1 or placebo. Primary outcomes assessed were (1) function of the knee joint, scored using the International Knee Documentation Committee (IKDC); and (2) pain, measured by Visual Analog Scale (VAS). Secondary endpoints assessed were pain and analgesic use, quality of life (QOL), and adverse events (AEs) including need for total knee arthroplasty after treatment.ResultsIKDC showed significant improvement in the GEC-TGF-β1 group over the placebo at week 12 (least mean square difference (LSMD): 10.3; P = 0.0342), week 52 (LSMD: 13.6; P = 0.0082), and overall (LSMD: 8.6; P = 0.0453). VAS Analysis showed a significant improvement in GEC-TGF-β1 group compared to placebo at weeks 12 (LSMD: −13.8; P = 0.0162), 52 (LSMD: −13.1; P = 0.0332), and overall (LSMD: −10.1; P = 0.0350). Reduction in pain severity at week 12 and 52, frequency at 24 h and week 52, and the percentage of patients in the GEC-TGF-β1 group receiving analgesics at week 4 (27 vs 40%) and 12 (27 vs 37%) was observed.ConclusionsGEC-TGF-β1 patients had more positive responses on the IKDC, VAS, and were less likely to require analgesics.Trial Number: ClinicalTrials.gov (NCT01221441) – “Study of TG-C in Patients with Grade 3 Degenerative Joint Disease of the Knee”

Identificación de riesgos geoambientales y su valoración en la zona de hundimiento del buque Prestige

Potential geological hazard assessment has been carried out in the area where the Prestige vessel was sunk using a broad database that comprises: multibeam, high and ultra-high resolution seismic profiles, gravity cores, onland seismicity stations and Ocean Bottom Seismometers (OBS). The main results of this study indicate that among the geologic factors that can be considered as potential hazards, four main categories can be differentiated based on their origin: morphologic, sedimentary, tectonic, and seismicity. Hazards of morphologic origin include steep gradients; the morphologic features suggest the occurrence of mass-wasting instabilities. Hazards of sedimentary origin also includes the occurrence of slope instability processes in form of single slides and a great variety of erosive and depositional gravity flows (debris and turbidity flows). Hazards of tectonic and seismic origin are important because the sinking area straddles the Calida Bank which is a structural seamount with a moderate tectonic activity that results in a latent seismicity of low to moderate magnitude. The interaction of these factors leads to consider to the risk as medium, and the degree of exposure of the bow and stern as high. Several general and specific recommendations are made in order to increase the geological and geophysics knowledgement in the Prestige sinking area and Spanish continental margins and deep sea areas. These recommendations also should be used to elaborate the options for reducing the hazard and loss

Inverted femoral head graft versus standard core decompression in nontraumatic hip osteonecrosis at minimum 3 years follow-up

Purpose Numerous salvage surgeries were popularised to halt the progression of hip osteonecrosis (ON). We aimed to compare the clinico-radiological outcomes of inverted femoral head graft (IFHG) versus standard core decompression (SCD) in treatment of nontraumatic hip ON at pre-arthritic stage. Methods A case review was performed at a minimum 3 years follow-up of 61 patients (71 hips; mean age 32.96 (19-50) years; mean follow-up 7.86 (3-14) years; mean body mass index 28.58 (19-46); 32 males, 29 females) suffering nontraumatic hip ON at pre-arthritic stage. 38 hips underwent SCD and 33 IFHG. The outcome was assessed by changes in modified Harris Hip Score (MHHS), need for revision surgery and progression of modified Ficat-Arlet staging. Data were analysed including logistic regression and Kaplan-Meier survivorship analysis. Results 13/34 (38.2%) hips in SCD group were revised at 4.61 ± 2.61 years, while 7/33 (21.2%) in IFHG group at 8.43 ± 4.32 years (p = 0.023). MHHS was significantly higher in IFHG group at 1 and 3 years as well as at last follow-up (p = 0.014, 0.001 and 0.023 respectively). Clinical and radiological significant differences were found in survivorship analysis between both groups, in favor of IFHG. A higher clinical failure was noted among obese patients. Conclusions An IFHG technique offers a better alternative regarding postoperative clinico-radiological outcomes in nontraumatic hip ON at the pre-arthritic stage. A cautious prognosis is recommended in obese patients