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FDA to take key stem-cell step
Government advisors meet this week to discuss designs for embryonic stem cell testing in humans.
By Aaron Smith, CNNMoney.com staff writer
April 9, 2008: 3:31 PM EDT
NEW YORK (CNNMoney.com) — The Food and Drug Administration looks like it’s bowing to the inevitable this week and drawing the blueprint for the first-ever human experiments with human embryonic stem cells.
FDA advisors meet Thursday and Friday to begin to design how these embryonic stem cell tests will be conducted. It’s an important regulatory step that could lead to human testing as early as this year. So far, biotechs have tested their spinal-cord drugs in animals, not people.
“[The FDA meeting] is the first step towards clinical trials,” said Laurie Zoloth, professor of medical humanities and bioethics at Northwestern University. “It’s an important moment. And it’s only the very beginning.”
Human embryos are prized by medical researchers because of their fast and malleable regenerative properties. In theory, they could be used to heal severed spines, as well as damaged or diseased brains, hearts and other organs.
But their use is one of the most controversial issues in medical research, a controversy that centers on whether embryonic cell groupings, called blastocysts, are considered human life.
The biotechs line up
Geron (GERN) could be the first company to conduct experiments in humans with drugs made from human embryonic stem cells. The biotech is developing a treatment to repair spinal cord injuries. Geron has already filed an application to the FDA to begin human testing, according to analysts. But the biotech refused to confirm this and would not discuss the upcoming meeting.
Advanced Cell is using embryonic stem cells to develop a treatment for vision loss. Chief scientific officer Robert Lanza said his company plans to file an application for human testing to the FDA within months. He said the company has found a way to “differentiate” stem cells to reduce the possibility of tumor formation.
Neuralstem (CUR) works with stem cells derived from a donated human fetus, rather than embryonic stem cells. CEO Richard Garr said his company is developing a treatment for Lou Gehrig’s disease, which degrades spinal cord nerve cells. He intends to file an application for human testing to the FDA in September or October.
Garr said that his company’s pig tests have been tumor-free, and he hopes the FDA panelists focus on the science of stem cells, not the controversy, in designing requirements for clinical trials.
“What we hope to come out of this meeting is rationality,” said Garr. “[We] hope that this isn’t just something that a stem cell-unfriendly administration is trying put in place before they leave.”