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The DRKS is an open access, free of charge online register for clinical trials and is available both in English and German. DRKS is part of the WHO's ICTRP. The DRKS works with two partner registries in Germany, DeReG (German Registry for Somatic Gene-Transfer Trials) and Clinical Trial Registry of the University Medical Center Freiburg. [4]
Since LPLD is a rare condition (prevalence worldwide 1–2 per million), related clinical tests and trials have involved unusually small cohort sizes. The first main trial (CT-AMT-011-01) involved just 14 subjects, [ 6 ] and by 2015, a total of 27 individuals had been involved in phase III testing. [ 7 ]
Based on preliminary trial data, the FDA had designated Zolgensma a breakthrough therapy, one of three special designations that helped it race from human trials to regulatory approval in five ...
Alipogene tiparvovec (Glybera): AAV-based treatment for lipoprotein lipase deficiency (no longer commercially available); Axicabtagene ciloleucel (Yescarta): treatment for large B-cell lymphoma [1]
Clinical trials of gene therapy for sickle cell disease were started in 2014. [227] [228] In February LentiGlobin BB305, a gene therapy treatment undergoing clinical trials for treatment of beta thalassemia gained FDA "breakthrough" status after several patients were able to forgo the frequent blood transfusions usually required to treat the ...
The Texas Children's Hospital is home to the center's Translational Research Labs and Good Manufacturing Practice (GMP) Laboratories. The Center for Cell and Gene Therapy has the largest academic GMP facility in the world, with 8,600 square feet of Class 10,000 (ISO7) cleanroom space. The GMP Gene Vector Lab produces clinical grade vectors for ...
Gene therapy is a medical procedure that involves inserting genetic material into a patient's cells to repair or fix a malfunctioning gene in order to treat hereditary illnesses. Between 1989 and December 2018, over 2,900 clinical trials of gene therapies were conducted, with more than half of them in phase I. [51]
Gilead Sciences and the U.S. government have settled a billion-dollar patent dispute over Gilead's HIV prevention drugs Truvada and Descovy, according to a Wednesday filing in Delaware federal court.
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