Etablissement Francais Du Sang | Date: 2015-02-17
The present invention relates to improved methods and kits for typing HLA class I and class II loci using DNA amplification and sequencing.
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: PHC-15-2014 | Award Amount: 6.00M | Year: 2015
Osteoarthritis (OA) is an incurable disease that has evaded pharmacological interference, biologic therapy or surgical intervention to prevent disease progression. Currently, OA is designated the 11th highest contributor (of 291 diseases) of global disability. In the absence of effective treatment options, cellular therapies using mesenchymal stem/stromal cells (MSCs) have emerged as potential candidates to overcome this clinical short-coming. Autologous adipose-derived mesenchymal stromal cells (ASCs) are attractive for cellular therapy given the abundance of tissue, high frequency of MSCs and minimally invasive harvest procedure. The EU consortium ADIPOA has shown in a first in man 2-centre Phase I safety study that intraarticular injection of a single dose of autologous ASCs to the knee (18 patients, 12 month follow-up) was well-tolerated, had no adverse effects, and resulted in an improvement in pain score and functional outcome. ADIPOA2 will deliver a large-scale clinical trial in regenerative medicine for OA. The purpose of the project is to design and implement a phase IIb study to assess the safety and efficacy of autologous (patient-derived) ACSs in the treatment of advanced OA of the knee. The cells will be prepared from samples of adipose tissue harvested from patients by lipoaspiration. ADIPOA2 will comprise a multi-centre, randomized clinical trial comparing culture-expanded, autologous adult ASCs in subjects with knee OA with another widely used therapeutic approach for knee degeneration (injection of Hyaluronan). There are two large elements of the study: (1) the production of consistent batches of high-quality autologous ASCs under GMP-compliant conditions and (2) delivery of these cell doses to patients in a trial which will meet all national and European regulatory and ethical standards and which will have sufficient statistical power to provide an unambiguous and definitive assessment of safety and efficacy.
Agency: European Commission | Branch: FP7 | Program: CP-IP | Phase: HEALTH-2009-1.4-2 | Award Amount: 15.47M | Year: 2010
Bone is among the most frequently transplanted tissue with about 1 million procedures annually in Europe. The worldwide market of bone replacement materials is currently estimated at 5 billion with a 10% annual growth. Despite their considerable disadvantages, including the risk of disease transfer and immunologic rejection, limited supply of bone, costs and complications, allografts and autografts account for more than 80% of total graft volume. Significant growth opportunities exist for synthetic bone grafts in association with mesenchymal stem cells from autologous or allogenic sources as alternatives to biological bone grafts in orthopaedic and maxillofacial surgery. The objectives of REBORNE is to perform clinical trials using advanced biomaterials and cells triggering bone healing in patients. In order to reach this goal, five phase II clinical studies with 20 patients are proposed in 12 clinical centres spread in 8 European countries. Three orthopaedic trials concerning the treatment of long bone fractures and osteonecrosis of the femoral head in adults or children will be conducted using bioceramics, hydrogel for percuteneous injection and stem cells from autologous or allogenic sources. Clinical research will also concern maxillofacial surgery with bone augmentation prior to dental implants and the reconstruction of cleft palates in children. The safety and efficacy of the new therapies will be assessed clinically using X-rays, CT scans and MRI as well as histology of biopsies. These ambitious clinical targets will require research and development efforts from a large consortium of top world class laboratories, SMEs manufacturing biomaterials, GMP-cell producing facilities and surgeons in hospitals as well as the consideration of ethical and regulatory issues. It is expected that REBORNE will expand the competitiveness of Europe through the patenting of new CE-marked bioproducts in the field of regenerative medicine.
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: PHC-15-2015 | Award Amount: 6.34M | Year: 2015
Stroke is the second leading cause of death in the world population. When not fatal, stroke often results in disability, due to motor and cognitive impairments, and secondary health problems affecting not only patients but also their families. Building on emerging preclinical and pilot clinical evidences, RESSTORE will focus on the clinical assessment of regenerative cell therapy to improve stroke recovery and patients quality of life. RESSTORE European multicentre randomised phase IIb will explore, for the first time, the efficacy (functional recovery) and safety of intravenous infusion of allogenic adipose tissue derived mesenchymal stem cells (ADMSCs) in 400 stroke patients. Therapeutic effects of ADMSCs will be assessed and monitored in patients using clinical rating scales, multimodal MRI and novel blood biomarkers. Additionally, the societal value and cost-effectiveness of ADMSCs-based regenerative therapy will be evaluated through health economics and predictive in silico simulations. Complementary ancillary animal studies will support the clinical trial by defining i) if the treatment response can be further enhanced by intensive rehabilitation, ii) the contribution of co-morbidities and iii) the mechanism(s) underlying the therapeutic effect. The European regenerative therapy capacities (France, Spain, Finland, United Kingdom and Czech Republic), developed in RESSTORE will cover the full value chain in the field (large scale GMP cell production, clinical testing, biomarkers discovery, understanding of the restoring mechanisms, modelling, biobanking, economic studies, exploitation and communication plan). RESSTORE will thus surely contribute, together with the workforce trained in the context of the programme, to improve its public and private (SME) competitiveness and increase the attractiveness of Europe as a reference location to develop and clinically assess new innovative therapeutic options for brain diseases.
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: SC1-PM-11-2016-2017 | Award Amount: 6.00M | Year: 2017
Current orthopaedic treatments permit spontaneous bone regeneration to unite and heal 90% bone injuries. Non-union associates pain and disability, often requiring biological enhancement. Regenerative medicine research suggests to the general public that alternative treatments based on advanced therapy medicinal products (ATMP) are already available. However, early clinical trials only explore its potential benefit. Underreported results and absence of early trial confirmation in adequately powered prospective randomized clinical trials (RCT) indicate that evidence is not available to transfer any technique into routine clinical application. This ORTHOUNION Project was developed from FP7-Project (REBORNE). Its results confirmed 92% bone healing rate (Gmez-Barrena et al, 2016 submitted manuscript) with an autologous ATMP of GMP expanded bone marrow derived human MSC in non-unions, where the reported bone healing rate after surgery with standard bone autograft is 74%. Any further development requires adequately powered prospective RCTs. This will be the main aim of ORTHOUNION: to assess clinically relevant efficacy of an autologous ATMP with GMP multicentric production in a well-designed, randomized, controlled, three-arm clinical trial under GCP, versus bone autograft, gold-standard in fracture non-unions. A non-inferiority analysis will evaluate if cell dose can be lowered. ATMP has been authorized by the National Competent Authorities of the participating countries in 3 previous trials (REBORNE) and will be monitored by ECRIN-ERIC to ensure quality and credibility of RCT results. Secondary aims include innovative strategies to increase manufacturing capacity and lower costs to pave translation into routine clinical treatments, biomaterial refinement to facilitate surgery, personalized medicine supportive instruments for patient selection and monitoring, and health economic evaluation. Results in this project may help define the future of bone regenerative medicine
University of Rennes 1, Etablissement Francais Du Sang and Rennes University Hospital Center | Date: 2014-02-07
The present invention relates to methods and kits for predicting the survival time of a patient suffering from a diffuse large B-cell lymphoma (DLBCL). In particular, the present invention relates to a method for predicting the survival time of a patient suffering from a diffuse large B-cell lymphoma (DLBCL) comprising the step of i) determining the level of sPD-L1 in a blood sample obtained from the patient ii) comparing the level determined at step i) with a predetermined reference value and iii) concluding that the patient has a poor prognosis when the level determined at step i) is higher than the predetermined reference value or concluding that the patient has a good prognosis when the level determined at step i) is lower than the predetermined reference value.
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: NMP-10-2014 | Award Amount: 8.00M | Year: 2015
The key therapeutic issue in diabetes mellitus type I and II is glycaemic control. Reductions of constant self-control, of insulin injections, and of long-term complications would have tremendous benefit for quality of life. The best therapy option is the transplantation of allogeneic islet cells, but the current state of the art limits the applicability of this approach. Implanting unprotected grafts requires lifelong administration of immunosuppressants, and protecting the cells against adverse immune reactions by current encapsulation strategies reduces their functionality and survival to an extend that makes frequent refresher implantations necessary. Currently, a maximum of 2 years glycaemia regulation has been shown for the encapsulated approach. In BIOCAPAN, bringing experts from different fields all together, we aim at developing an innovative treatment, based on the implantation of allogeneic islet cells that are embedded in a complex microcapsule. We will design a GMP-grade bioactive microcapsule that will maximize the long-term functionality and survival of pancreatic islets by prevention of pericapsular fibrotic overgrowth, in situ oxygenation, innovative extracellular matrix microenvironment reconstruction and immune-system modulation. We will establish a GMP-grade microfluidic microencapsulation platform to protect freshly harvested islets quickly in a standardized and reproducible way. We aim for full preclinical validation and we will establish a complete protocol in accordance with the provisions of the Advanced Therapy Medicinal Products Regulation, in order to start clinical trials within one year after the end of the project. We aim for 5-years insulin injection free treatment, without immunosuppressants, which would tremendously benefit diabetes mellitus patients who require insulin (all Type I and about one in six Type II Diabetes Mellitus patients).
Jean Monnet University, Ecole Nationale Superieure des Mines de Saint - Etienne CMP and Etablissement Francais Du Sang | Date: 2013-03-14
A device for the storage of a corneal specimen has means for the reception and entrapment of a corneal specimen, connected to the means for the creation of a pressure gradient with overpressure on the endothelial side and to the preservation medium circulation means in the layouts that present the means for the reception and entrapment of the cornea specimen. The means for the reception and entrapment of the corneal specimen entrap the sclera ciliary zone surrounding the cornea in an airtight manner to delimit a separate endothelial chamber and epithelial chamber in which the preservation medium can circulate with an overpressure in the endothelial chamber; The intermediate component and the endothelial lid comprise inlet and outlet orifices for the preservation medium which are connected to the means for the circulation of the preservation medium and the creation of a pressure gradient between the endothelial chamber and the epithelial chamber with overpressure in the endothelial chamber.
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: Health | Award Amount: 3.04M | Year: 2014
The objective of this proposal is to urgently determine the efficacy, safety and feasibility of convalescent whole blood (CWB) and convalescent plasma (CP) therapy, as a treatment for patients with Ebola Viral Disease (EVD) to reduce the case fatality rate in the present EVD epidemic in West Africa. The trial will take place in three consecutive phases; i) initial phase to initiate harmonized standard supportive care (SC), ii) evaluation of CWB iii) evaluation of CP. Supportive care (SC) including intravenous hydration and shock management will be standardised and made available to all patients. Day 14 mortality will be used to determine primary outcome. Survival for patients treated with CWB \ SC or CP \ SC will be compared to SC alone using a non-randomised open-label design. Based on available figures, a 20% decrease in the case fatality rate will be considered proof of clinical efficacy. Internationally agreed stands of ethics and human rights will be applied for the duration of the trial. Written consent will be requested from patients and/or guardians of patients. Every consideration will be given to the safely of health-care workers involved in the trial, including their consent to be involved and adequate training and psycho-emotional support. Given the study context, community communication will be prioritized. We propose a unique partnership of academics, clinical trial units, non-governmental organizations, international research networks, international and local actors to conduct a clinical trial according to the highest standards attainable in the current context. If found to be effective, this intervention can be scaled-up relatively rapidly as the trial will provide the information required to mobilize local partners, with major public health implications.
Etablissement Francais Du Sang and Maco Pharma | Date: 2013-10-09
A method for preserving whole placental blood comprising introducing whole placental blood into an air barrier storage bag, storing said bag containing whole placental blood at a temperature of more than 0 C. and less than 40 C., so as to preserve the whole placental blood.