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Gene therapy may offer release from sterile isolation for patients lacking immune systems Part 2 (Teacher: Michael)

Bone marrow transplants also successful in some cases, but they pose serious risks of their . There no available donor for the two children in the study, who seven months-old, and two years and six months old.

"With gene therapy you treat every patient, and the toxicity is enormously lower than for bone marrow transplants. We propose at this stage, that every patient lacking a donor with an identical tissue type directed to gene therapy," Bordignon.

Bordignon's team test their therapy on more volunteers before it approved for researchers to in Italy or abroad. They start with patients without a matched donor for a bone marrow transplant, and then include patients for whom a donor is available. Because ADA-SCID is a relatively rare disorder, these studies function as phase I and II clinical trials, meaning they aim to demonstrate that the procedure is both safe and effective, Bordignon .

In to extend this method to a larger population of Italian patients, the is seeking the approval of Italy's Istituto Superiore di Sanità. A similar application process necessary for performing the therapy elsewhere in Europe and in the United States. Because the therapy considered under the "orphan drug" category, meaning a treatment for a rare disease, the approval process in Europe likely relatively fast, lasting a few months, according to Bordignon.

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