This is the world’s first IRB-approved clinical trial aimed at reversing aging by at least 20 years; it is also the world’s most expensive pay-to-play trial with a one million price tag to enroll.
This isn’t a human research ethics vignette/scenario, but could very easily be used as the basis for a discussion with researchers, research ethics reviewers, research ethics advisers, or research office staff about:
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- Pay-to-play clinical trials
- Appropriate recruitment materials
- The use of ethics approval as a sales tool
- The conduct of trials in another country
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Under Libella’s pay-to-play model, trial participants will be enrolled in their country of origin after paying $1 million. Participants will travel to Colombia to sign their informed consent and to receive the Libella gene therapy under a strictly controlled hospital environment.
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Traditionally, aging has been viewed as a natural process. This view has shifted, and now scientists believe that aging should be seen as a disease. The research in this field has led to the belief that the kingpin of aging in humans is the shortening of our telomeres.
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Telomeres are the body’s biological clock. Every time a cell divides, telomeres shorten, and our cells become less efficient at dividing again. This is why we age. A significant number of scientific peer-reviewed studies have confirmed this. Some of these studies have shown actual age reversal in every way imaginable simply by lengthening telomeres.
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