News Article | December 5, 2016
SAN DIEGO, Dec. 05, 2016 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) Topline review of early three-year follow-up data from the SCLERADEC I trial shows sustained benefit in treated patients over baseline in major study endpoints. The data indicate the following: The full data set will be presented by the Investigators at a forthcoming scientific meeting. “The longevity of the clinical response of a single therapeutic administration of ECCS-50 is an importing finding,” said Dr. Marc H. Hedrick, Cytori President and Chief Executive Officer. “As we prepare for commercial launch and interview payors, duration of effect seems to be one of many potentially attractive aspects of the therapy when compared to current available options.” The SCLERADEC I trial was a 12-patient, open label, single arm, investigator-initiated study conducted at Assistance Publique Hôpitaux de Marseille (APHM), France led by Drs. Brigitte Granel and Guy Magalon supported by the team of Pr. Florence Sabatier of the Cell Therapy Department of Hôpital de le Conception, APHM, with financial support from the French Scleroderma Research Group (GFRS) and with additional support from Cytori. Furthermore, Cytori recently announced publication of two-year clinical follow-up of the SCLERADEC I trial. The results were published in the journal Current Research in Translational Medicine, and is accessible online. Cytori has recently enrolled the STAR trial, a Phase 3, U.S. multi-center, randomized controlled trial of Cytori Cell Therapy™ in the same indication as the SCLERADEC I trial, hand dysfunction and Raynaud’s Phenomenon associated with scleroderma. The STAR trial randomized 88 subjects and completed enrollment in mid-2016. Data unblinding and analysis will commence once the last enrolled subject has competed their 48 week follow-up visit, anticipated to be in mid-2017. About Cytori Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information visit www.cytori.com. Cautionary Statement Regarding Forward-Looking Statements This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including statements regarding availability and publication of clinical data regarding Cytori’s scleroderma therapeutic (ECCS-50), and ECCS-50’s potential duration of effect (as a possibly attractive aspect of the therapy to payers), are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, inherent risk and uncertainty in the conduct of clinical trials and clinical trial results (including risks associated with investigator-initiated trials), risks in the collection of clinical data (including collection and accuracy of the limited, open-label 12-patient SCLERADEC I pilot trial data), final clinical outcomes risks, risk regarding protection of intellectual property rights, regulatory uncertainties, risks regarding dependence on third party performance, competitive risks (including potential introduction of superior alternative therapeutic approaches to scleroderma), and performance and acceptance of our products in the marketplace, as well as other risks and uncertainties described under the heading "Risk Factors" in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
News Article | November 29, 2016
SAN DIEGO, Nov. 29, 2016 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) announced today publication of two-year clinical follow-up of patients treated with a single administration of ECCS-50 in the SCLERADEC-I pilot trial of Cytori Cell Therapy in patients with hand dysfunction associated with scleroderma. The results, published by Dr. Brigitte Granel and colleagues of the Assistance Publique des Hôpitaux de Marseille, were published in the journal Current Research in Translational Medicine. The manuscript is now accessible online. The authors report that key clinical benefits reported at the 6-month time point of the trial were sustained at two years (follow up range of 22–30 months). The primary endpoint, Cochin Hand Function Score improved 62.5% over baseline (18.6±13.8 at two years vs. 48.5±10.8; p<0.0001). Key secondary endpoints also improved from baseline. Specifically, pain was reduced from 59.4±17.2 at baseline to 29.5±25.2 at two years (p=0.02), scleroderma-associated disability was reduced by 51.1% (0.7±0.5 vs. 1.4±0.3; p=0.0051), and Raynaud’s Condition Score improved by 88.3% (0.8±0.9 vs. 7.2±0.9; p<0.0001). In addition, key objective measures of scleroderma hand involvement showed sustained benefit: digital ulcers remained reduced from baseline by 60% (6 vs. 15 at baseline) and improvement in pinch strength was also sustained. Trends indicating improvement in hand mobility were also reported. An interesting finding noted by the authors was that eight patients who had been treated previously with prostanoids had not required subsequent re-treatment with these agents in the two year follow up period. “The long-term follow data from this small, open label trial, continues to suggest that a single administration is safe and may provide long term benefits across multiple scleroderma symptoms,” said Dr. Marc H. Hedrick, M.D., Cytori’s President & Chief Executive Officer. “Scleroderma is a very complex disease but shares common features with other connective tissue disorders that may be attractive future targets for the therapy.” The SCLERADEC I trial was a 12 patient, single arm, open label study led by Drs. Brigitte Granel and Guy Magalon of APHM supported by the team of Pr. Florence Sabatier of the Cell Therapy Department of Hôpital de le Conception, Assistance Publique-Hôpitaux de Marseille. About Cytori Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information, visit www.cytori.com. Cautionary Statement Regarding Forward-Looking Statements This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including without limitation, statements regarding safety and potential benefits of Cytori Cell Therapy (including statements suggesting that Cytori Cell Therapy may provide long term benefits across multiple scleroderma symptoms), and the possibility that other connective tissue disorders may be potentially attractive future targets for Cytori Cell Therapy, are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, inherent risk and uncertainty in the conduct of clinical trials and clinical trial results (including risks associated with investigator-initiated trials), risks in the collection of clinical data (including collection and accuracy of the limited, open-label 12-patient SCLERADEC I pilot trial data), final clinical outcomes risks, risk regarding protection of intellectual property rights, regulatory uncertainties, risks regarding dependence on third party performance, competitive risks (including potential introduction of superior alternative therapeutic approaches to scleroderma), and performance and acceptance of our products in the marketplace, as well as other risks and uncertainties described under the heading "Risk Factors" in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
Le Corroller T.,APHM |
Le Corroller T.,Aix - Marseille University |
Bauones S.,APHM |
Acid S.,APHM |
And 2 more authors.
European Radiology | Year: 2013
Objectives: To determine whether ultrasound allows precise assessment of the course and relations of the dorsal cutaneous branch of the ulnar nerve (DCBUN). Methods: This work, initially undertaken in cadavers, was followed by high-resolution ultrasound study in 20 healthy adult volunteers (40 nerves) by two musculoskeletal radiologists in consensus. Location and course of the DCBUN and its relations to adjacent anatomical structures were analysed. Results: The DCBUN was consistently identified along its entire course by ultrasound. Mean cross-sectional area of the nerve was 1.6 mm2 (range 1.1-2.2). The level at which the DCBUN branches from the ulnar nerve was located a mean of 57 mm (range 40-80) proximal to the ulnar styloid process and 11 mm (range 7-15) radial to the medial border of the ulna. The DCBUN then crossed the medial border of the ulna a mean of 14 mm (range 6-25) proximal to the ulnar styloid process. Conclusion: The DCBUN is clearly depicted by ultrasound. Precise mapping of its anatomical course could have significant clinical applications, such as preventing injury during surgery of the ulnar side of the wrist or helping in the diagnosis of chronic pain of the ulnar side of the hand. Key Points: • The dorsal cutaneous branch of the ulnar nerve (DCBUN) is often injured. • The DCBUN originates from the ulnar nerve in the distal third of the forearm. • It can be clearly depicted by ultrasound. • The level at which the DCBUN crosses the ulna is variable. • Precise mapping of its anatomical course could have significant clinical applications. © 2013 European Society of Radiology.
Boyer L.,APHM |
Baumstarck K.,APHM |
Guedj E.,APHM |
Guedj E.,Aix - Marseille University |
And 2 more authors.
Expert Review of Pharmacoeconomics and Outcomes Research | Year: 2014
The authors propose a reflection on quality of life (QoL) measures in medicine following the work of G. Canguilhem on health and disease and the latest results from neuroimaging. The use of QoL measures implies that the tension between the two competing visions of health (i.e., normative and descriptive) needs to be overcome. A profound cultural change is needed if we want clinicians, researchers and decision makers to suspend their prevailing scientific ideologies about disease and examine the content of the patient's experience. Another issue that concerns the direction of future QoL is that until now, the available measurements and recent work were ambiguous, trying to find a commonly acceptable, intermediate position halfway between these normative and descriptive visions. It may be time to discard the medical normative vision and instead assume a radically humanistic approach to medicine by providing purely descriptive measures based on the values and emotions of patients. © 2014 Informa UK Ltd.
Nature Immunology | Year: 2016
Innate lymphoid cells (ILCs) have potent immunological functions in experimental conditions in mice, but their contributions to immunity in natural conditions in humans have remained unclear. We investigated the presence of ILCs in a cohort of patients with severe combined immunodeficiency (SCID). All ILC subsets were absent in patients with SCID who had mutation of the gene encoding the common γ-chain cytokine receptor subunit IL-2Rγ or the gene encoding the tyrosine kinase JAK3. T cell reconstitution was observed in patients with SCID after hematopoietic stem cell transplantation (HSCT), but the patients still had considerably fewer ILCs in the absence of myeloablation than did healthy control subjects, with the exception of rare cases of reconstitution of the ILC1 subset of ILCs. Notably, the ILC deficiencies observed were not associated with any particular susceptibility to disease, with follow-up extending from 7 years to 39 years after HSCT. We thus report here selective ILC deficiency in humans and show that ILCs might be dispensable in natural conditions, if T cells are present and B cell function is preserved. © 2016 Nature Publishing Group, a division of Macmillan Publishers Limited. All Rights Reserved.
Bisbal M.,Aix - Marseille University |
Jouve E.,APHM |
Papazian L.,Aix - Marseille University |
de Bourmont S.,Aix - Marseille University |
And 3 more authors.
Resuscitation | Year: 2014
Purpose: The mortality for patients admitted to intensive care unit (ICU) after cardiac arrest (CA) remains high despite advances in resuscitation and post-resuscitation care. The Simplified Acute Physiology Score (SAPS) III is the only score that can predict hospital mortality within an hour of admission to ICU. The objective was to evaluate the performance of SAPS III to predict mortality for post-CA patients. Methods: This retrospective single-center observational study included all patients admitted to ICU after CA between August 2010 and March 2013. The calibration (standardized mortality ratio [SMR]) and the discrimination of SAPS III (area under the curve [AUC] for receiver operating characteristic [ROC]) were measured. Univariate logistic regression tested the relationship between death and scores for SAPS III, SAPS II, Sequential Organ Failure Assessment (SOFA) Score and Out-of-Hospital Cardiac Arrests (OHCA) score. Independent factors associated with mortality were determined. Results: One-hundred twenty-four patients including 97 out-of-hospital CA were included. In-hospital mortality was 69%. The SAPS III was unable to predict mortality (SMRSAPS III: 1.26) and was less discriminating than other scores (AUCSAPSIII: 0.62 [0.51, 0.73] vs. AUCSAPSII: 0.75 [0.66, 0.84], AUCSOFA: 0.72 [0.63, 0.81], AUCOHCA: 0.84 [0.77, 0.91]). An early return of spontaneous circulation, early resuscitation care and initial ventricular arrhythmia were associated with a better prognosis. Conclusions: The SAPS III did not predict mortality in patients admitted to ICU after CA. The amount of time before specialized CPR, the low-flow interval and the absence of an initial ventricular arrhythmia appeared to be independently associated with mortality and these factors should be used to predict mortality for these patients. © 2014 Elsevier Ireland Ltd.
Gour N.,Aix - Marseille University |
Felician O.,Aix - Marseille University |
Didic M.,Aix - Marseille University |
Koric L.,APHM |
And 6 more authors.
Human Brain Mapping | Year: 2014
At a similar stage, patients with early onset Alzheimer's disease (EOAD) have greater neocortical but less medial temporal lobe dysfunction and atrophy than the late-onset form of the disease (LOAD). Whether the organization of neural networks also differs has never been investigated. This study aims at characterizing basal functional connectivity (FC) patterns of EOAD and LOAD in two groups of 14 patients matched for disease duration and severity, relative to age-matched controls. All subjects underwent an extensive neuropsychological assessment. Magnetic resonance imaging was used to quantify atrophy and resting-state FC focusing on : the default mode network (DMN), found impaired in earlier studies on AD, and the anterior temporal network (ATN) and dorso-lateral prefrontal network (DLPFN), respectively involved in declarative memory and executive functions. Patterns of atrophy and cognitive impairment in EOAD and LOAD were in accordance with previous reports. FC within the DMN was similarly decreased in both EOAD and LOAD relative to controls. However, a double-dissociated pattern of FC changes in ATN and DLPFN was found. EOAD exhibited decreased FC in the DLPFN and increased FC in the ATN relative to controls, while the reverse pattern was found in LOAD. In addition, ATN and DLPFN connectivity correlated respectively with memory and executive performances, suggesting that increased FC is here likely to reflect compensatory mechanisms. Thus, large-scale neural network changes in EOAD and LOAD endorse both common features and differences, probably related to a distinct distribution of pathological changes. © 2013 Wiley Periodicals, Inc.
Linssen W.H.J.P.,St Lucas Andreas Hospital |
de Voogt W.G.,St Lucas Andreas Hospital |
Krahn M.,APHM |
Bernard R.,APHM |
And 4 more authors.
European Journal of Neurology | Year: 2013
Background and purpose: To describe the long-term follow-up of a cohort of 22 patients with the Miyoshi phenotype of distal muscular dystrophy (MMD). Methods: A long-term clinical follow-up study was conducted. Patients were genotyped for dysferlin (MMD1) or anoctamin 5 (MMD3) mutations. Patients also underwent cardiological evaluation. Results: There were 10 patients with MMD1, eight patients with MMD3 and four patients with linkage to chromosome 10 (MMD2). All patients deteriorated over 5.7 (range: 4.2-6.6) years of follow-up. Weakness increased significantly (P<0.035) in all but the neck extensor, serratus anterior, and wrist flexor and extensor muscles. The decrease of strength was most pronounced in the iliopsoas (15%), toe extensors (15%), anterior tibial and peroneal muscles (10%). Patients with MMD1 showed early onset of the disease (mean 22years) with typically symmetrical distribution of weakness starting in the calf muscles. Patients with MMD1 had a worse clinical course compared with patients with MMD3. Ninety percent of the former had to make use of a wheelchair within 15years after onset of the disease, whereas patients with MMD3, who have a significantly later onset (mean 35years) of asymmetrical calf muscle weakness and atrophy, remained ambulant during the first 15years of their disease. None of the patients with MMD2 became fully confined to the wheelchair. None of the 22 MMD phenotype patients had heart disease. Conclusions: Patients with MMD1 have a worse clinical course compared with patients with MMD3. There are no cardiological abnormalities in all MMD categories. © 2013 EFNS.
Eusebio A.,APHM |
Eusebio A.,Aix - Marseille University |
Azulay J.P.,APHM |
Azulay J.P.,Aix - Marseille University |
And 6 more authors.
European Journal of Nuclear Medicine and Molecular Imaging | Year: 2012
Purpose Several studies have shown age- and genderrelated differences in striatal dopamine transporter (DaT) binding. These studies were based on a striatal region on interest approach that may have underestimated these effects and could not evaluate extrastriatal regions. Our aim was to determine the effects at the voxel level of age and gender on whole-brain DaT distribution using [123I]FP-CIT SPECT in healthy subjects. Methods We performed a whole-brain [123I]FP-CIT SPECT voxel-based analysis using SPM8 and a standardized normalization template (p<0.05, corrected using the false discovery rate method) in 51 healthy subjects aged from 21 to 79 years. Results We found an age-related DaT binding decrease in the striatum, anterior cingulate/medial frontal cortices and insulo-opercular cortices. Also DaT binding ratios were higher in women than men in the striatum and opercular cortices. Conclusion This study showed both striatal and extrastriatal age-related and gender-related differences in DaT binding in healthy subjects using a whole-brain voxel-based non-a priori approach. These differences highlight the need for careful age and gender matching in DaT analyses of neuropsychiatric disorders. © Springer-Verlag 2012.
Tabouret E.,Institute Paoli Calmettes |
Gravis G.,Institute Paoli Calmettes |
Cauvin C.,Institute Paoli Calmettes |
Loundou A.,Aix - Marseille University |
And 2 more authors.
European Spine Journal | Year: 2014
Results: Median OS was 7.8 months (95 % confidence interval 4.4–11.2). Thirty-nine patients presented with OS ≥2 years. A comparative analysis found significant differences concerning the delay (first symptom–surgery, p < 0.001), number of systemic (p = 0.001) or bone metastases (p = 0.013), Karnofsky performance status (KPS) (p = 0.006), Frankel (p = 0.025), ASA scores (p < 0.001), weight loss (p = 0.003), hyperalgia (p = 0.002), chemotherapy use (p = 0.034), and primary tumor (p < 0.001). RPA classification identified six prognostic classes based on the ASA score, primary type, KPS, and systemic metastases.Conclusion: Long-term metastatic cancer survivor patients are an increasing population with specific characteristics.Purpose: Metastatic spinal cord compression (MSCC) incidences are increasing. Our objective was to identify predictive factors involved in long-term survival after use of a surgical approach.Methods: We retrospectively analyzed all patients referred to our institution for MSCC who underwent surgery (N = 138). We identified patients with an overall survival (OS) rate greater than 2 years, compared their characteristics to the remaining patients, and performed recursive partitioning analysis (RPA). © 2014, Springer-Verlag Berlin Heidelberg.