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4.
Regul Toxicol Pharmacol ; 106: 187-196, 2019 Aug.
Article in English | MEDLINE | ID: mdl-31051191

ABSTRACT

An early dialogue between nanomedicine developers and regulatory authorities are of utmost importance to anticipate quality and safety requirements for these innovative health products. In order to stimulate interactions between the various communities involved in a translation of nanomedicines to clinical applications, the European Commission's Joint Research Centre hosted a workshop titled "Bridging communities in the field of Nanomedicine" in Ispra/Italy on the 27th -28th September 2017. Experts from regulatory bodies, research institutions and industry came together to discuss the next generation of nanomedicines and their needs to obtain regulatory approval. The workshop participants came up with recommendations highlighting methodological gaps that should be addressed in ongoing projects addressing the regulatory science of nanomedicines. In addition, individual opinions of experts relevant to progress of the regulatory science in the field of nanomedicine were summarised in the format of a survey.


Subject(s)
Nanomedicine , Decision Making , Decision Support Systems, Clinical , Humans , Surveys and Questionnaires
5.
Front Surg ; 4: 61, 2017.
Article in English | MEDLINE | ID: mdl-29164130

ABSTRACT

BACKGROUND: Instability of the knee, related to anterior cruciate ligament injury, is treated by surgical reconstruction. During recovery, a loss of proprioceptive input can have a significant impact. Few studies have evaluated the benefits of rehabilitation of the knee in aquatic environment on functional outcomes. OBJECTIVE: This study aimed to compare an innovative rehabilitation protocol combining reduced conventional rehabilitation with aquatic rehabilitation, with a conventional rehabilitation, according to the National French Health Authority, in terms of kinetics, development of proprioceptive skills, and functional improvement of the knee. METHODS: 67 patients, who were amateur or professional athletes, were randomized into two groups: 35 patients followed the conventional rehabilitation protocol (Gr1) and 32 patients followed the innovative rehabilitation protocol (Gr2). Patients were evaluated before surgery, and at 2 weeks, 1, 2, and 6 months after surgery using posturography, and evaluation of muscular strength, walking performance and proprioception. This study is multicenter, prospective, randomized, and controlled with a group of patients following conventional rehabilitation (level of evidence I). RESULTS: For the same quality of postural control, Gr2 relied more on somesthesia than Gr1 at 6 months. The affected side had an impact on postural control and in particular on the preoperative lateralization, at 2 weeks and at 1 month. Lateralization depended on the affected knee, with less important lateralization in Gr2 preoperatively and at 1 month. The quadriceps muscular strength was higher in Gr2 than in Gr1 at 2 and 6 months and muscle strength of the external hamstring was greater in Gr2 than in Gr1 at 6 months. The isokinetic test showed a greater quadriceps muscular strength in Gr2. Gr2 showed a greater walking distance than Gr1 at one month. Gr2 showed an improvement in the proprioceptive capacities of the operated limb in flexion for the first 2 months. CONCLUSION: The effectiveness of the innovative rehabilitation program permits faster recovery, allowing for an earlier return to social, sporting, and professional activities. Faster retrieval of knee function following aquatic rehabilitation would prevent both short-term risk of lesions of the contralateral limb due to overcompensation and long-term risk of surgery due to osteoarthritis. REGISTRATION OF CLINICAL TRIALS: NCT02225613.

6.
Nanotoxicology ; 11(2): 147-149, 2017 03.
Article in English | MEDLINE | ID: mdl-28055261

ABSTRACT

Nanotechnology has transformed materials engineering. However, despite much excitement in the scientific community, translation of nanotechnology-based developments has suffered from significant translational gaps, particularly in the field of biomedicine. Of the many concepts investigated, very few have entered routine clinical application. Safety concerns and associated socioeconomic uncertainties, together with the lack of incentives for technology transfer, are undoubtedly imposing significant hurdles to effective clinical translation of potentially game-changing developments. Commercialisation aspects are only rarely considered in the early stages and in many cases, the market is not identified early on in the process, hence precluding market-oriented development. However, methodologies and in-depth understanding of mechanistic processes existing in the environmental, health and safety (EHS) community could be leveraged to accelerate translation. Here, we discuss the most important stepping stones for (nano)medicine development along with a number of suggestions to facilitate future translation.


Subject(s)
Clinical Medicine , Nanomedicine , Nanotechnology/methods , Biomedical Research , Clinical Medicine/economics , Clinical Medicine/methods , Clinical Medicine/standards , Environmental Health , Humans , Nanomedicine/economics , Nanomedicine/methods , Nanomedicine/standards , Safety
7.
Biochem Biophys Res Commun ; 468(3): 511-7, 2015 Dec 18.
Article in English | MEDLINE | ID: mdl-26518648

ABSTRACT

Nanomedicine is an emerging and rapidly evolving field and includes the use of nanoparticles for diagnosis and therapy of a variety of diseases, as well as in regenerative medicine. In this mini-review, leaders in the field from around the globe provide a personal perspective on the development of nanomedicine. The focus lies on the translation from research to development and the innovation supply chain, as well as the current status of nanomedicine in industry. The role of academic professional societies and the importance of government funding are discussed. Nanomedicine to combat infectious diseases of poverty is highlighted along with other pertinent examples of recent breakthroughs in nanomedicine. Taken together, this review provides a unique and global perspective on the emerging field of nanomedicine.


Subject(s)
Biomedical Research/trends , Diagnostic Imaging/trends , Forecasting , Internationality , Nanomedicine/trends , Nanoparticles/therapeutic use , Drug Design
8.
J Photochem Photobiol B ; 130: 161-9, 2014 Jan 05.
Article in English | MEDLINE | ID: mdl-24333764

ABSTRACT

Among various attempts to enhance the therapeutic efficacy of photodynamic therapy (PDT), the specific delivery of photosensitizer (PS) in the tumor tissue is expected to improve its clinical applications. The aim of this study was to engineer lipid nanoparticles (LNP) with different sizes and various PS contents, using simple solvent-free and easily scale up manufacturing processes. Meso-(tetrahydroxyphenyl) chlorin (mTHPC) is one of the most potent photoactive compounds for clinical use. We demonstrated that mTHPC was efficiently incorporated into the lipid core of LNP, leading to a large range of stable and reproducible mTHPC-loaded LNP with narrow size distribution. Photophysical and physico-chemical properties of mTHPC-loaded LNP were assessed as well as absorption spectra and singlet oxygen emission, colloidal stability, particle size and zeta potential. The photocytotoxicity of selected mTHPC-loaded solid LNP was demonstrated on MCF-7 cells under irradiation at 652nm with a range of light fluence from 1.0 to 10J/cm(2). All physico-chemical, photophysical and biological results allow us to conclude that solid LNP appear as a very promising nano-mTHPC delivery system for PDT.


Subject(s)
Drug Carriers/chemistry , Lipids/chemistry , Mesoporphyrins/chemistry , Nanoparticles/chemistry , Photosensitizing Agents/chemistry , Cell Survival/drug effects , Drug Carriers/administration & dosage , Drug Compounding , Humans , Light , MCF-7 Cells , Mesoporphyrins/administration & dosage , Nanoparticles/administration & dosage , Photochemotherapy , Photosensitizing Agents/administration & dosage , Singlet Oxygen/chemistry
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