Safety Profile of Good Manufacturing Practice Manufactured Interferon γ-Primed Mesenchymal Stem/Stromal Cells for Clinical Trials
نویسندگان
چکیده
منابع مشابه
Clinical trials: towards good practice.
Quality control, quality assurance, and audit are now an integral, though not always welcome, part of our daily lives. For many years the conduct of clinical trials has relied heavily on trust and the integrity of those involved, and the amount of regulation has been minimal. The introduction of the Declaration of Helsinki in 1964 spelt out the ethical considerations but further changes over th...
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Numerous studies have demonstrated that interferon-γ (IFN-γ) is an important inflammatory cytokine, which may activate the immunomodulatory abilities of mesenchymal stem cells (MSCs), and may influence certain other functions of these cells. MicroRNAs are small non‑coding RNAs that regulate the majority of the biological functions of cells and are important in a variety of biological processes....
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Mesenchymal stem cells (MSC) are being used increasingly in clinical trials for a range of regenerative and inflammatory diseases. Bone marrow is the traditional source but is relatively inaccessible in large volume. MSC have now been derived from tissues other than bone marrow including placenta and adipose tissue. We have used placenta obtained after delivery as a source of MSC and have been ...
متن کاملValidation of Instruments for Assessing Drug Safety Management During the Conduction of Clinical Trials
Background The management of drug safety with the collection of reliable safety data during the conduction of clinical trials conduct is essential for the registry and marketing of products. The systematic evaluation of this process, based on objective measures, requires the application of quality instruments. This study was aimed to design and validate eight instruments through the components ...
متن کاملEffectiveness and safety profile of leflunomide in rheumatoid arthritis: actual practice compared with clinical trials.
OBJECTIVE Leflunomide, an immunosuppressant agent for treating rheumatoid arthritis, was first marketed in France in 2000. Three years after its launch, we sought to assess its prescription patterns in the real world of prescription and use, and to see if its efficacy and safety profiles observed during clinical trials were confirmed. METHODS All patients treated with leflunomide from May 200...
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ژورنال
عنوان ژورنال: STEM CELLS Translational Medicine
سال: 2017
ISSN: 2157-6564
DOI: 10.1002/sctm.16-0485