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By Mayo Clinic staffCurrently, the only way for you to receive gene therapy is to participate in a clinical trial. These studies help doctors determine whether a gene therapy approach is safe for people. They also demonstrate the effects of gene therapy on the body. For instance, doctors may analyze samples of cells from people in a gene therapy clinical trial to look for signs that the makeup of diseased cells is changing. They might also look to see how the immune system reacts to the gene therapy.
Your specific procedure will depend on the disease you have and the type of gene therapy being used. For example, in some clinical trials, you may have blood drawn, or you may need a bone marrow aspiration — a procedure in which a liquid sample of your bone marrow is withdrawn — or a bone marrow biopsy — a procedure in which a sample of solid marrow material is taken. Then, in a laboratory, cells from the blood or bone marrow are exposed to a virus or another type of vector that contains the desired genetic material. Once the vector has entered the cells in the laboratory, those cells are then injected back into your body through a vein. In other research studies, the vector is injected or given intravenously (IV) into tissue in the body, where the cells take up the vector along with the altered genes.
Viruses aren't the only vectors that can be used to carry altered genes into your body's cells. Other vectors sometimes used in clinical trials include:
- Stem cells. Stem cells are the raw material cells of your body — cells from which all other cells in your body with specialized functions are created. For gene therapy, stem cells can be altered in a laboratory to accept new genes that can help fight disease.
- Liposomes. These fatty particles have the ability to carry the new, therapeutic genes to the target cells and pass the genes into your cells' DNA.
- Gene therapy. Centre for Genetics Education. http://www.genetics.edu.au/pdf/factsheets/fs27.pdf. Accessed Sept. 7, 2010.
- Gene therapy for cancer: Questions and answers. National Cancer Institute. http://www.cancer.gov/cancertopics/factsheet/Therapy/gene. Accessed Sept. 7, 2010.
- Gene therapy. Human Genome Project Information. http://www.ornl.gov/sci/techresources/Human_Genome/medicine/genetherapy.shtml. Accessed Sept. 7, 2010.
- Genetics home reference. National Library of Medicine. http://ghr.nlm.nih.gov/handbook. Accessed Sept. 7, 2010.
- Wieben ED (expert opinion). Mayo Clinic, Rochester, Minn. Sept. 18, 2010
- About clinical trials. American Society of Gene & Cell Therapy. http://www.asgct.org/educational_resources/clinical_trials.php. Accessed Sept. 24, 2010.
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