Feb 05

Stem cell treatment on human approved by FDA

The first therapy study on a human subject using human embryonic stem cells was approved by the American government, making the U.S. a pioneer in this field, and opening new doors to research targeting injuries and incurable diseases.

The American agency’s spokeswoman Susan Cruzan has confirmed that: “The food and drug administration (FDA) has authorized a phase I clinical trial from Geron Corporation (a California-based biotech company that focuses on therapeutic products for cancer, cell aging, injury or degenerative diseases). This phase I trial will treat patients with severe spinal cord injuries”. The biotech company had submitted a 21 000 pages report to support their request, showing that the investigative therapy showed a high efficiency on rats and other rodents.

This phase I clinical trial will be conducted on a small group of patients to assess human response to this new therapy. “This novel therapy is a sign of a new era in medical discoveries and therapies” says the Geron Corporation C.E.O., Thomas Okarma. And he adds “This new treatment represents the first cell therapy that could be made and developed in a similar way to that of a biological treatments or antibodies. The therapy uses the normal biological development of the human body, and we anticipate to permanently be able to cure chronic diseases and trauma.”

Embryonic stem cells are the only stem cells that have the ability to grow and develop in any other type of cells. Therefore, the goal of the GRNOPC1 study is to inject human embryonic stem cells on paralyzed volunteers, in the hope that those cells will be able to generate new neural cells and replace the damaged ones, potentially allowing paralyzed people to regain sensitivity and eventually the ability to move.

Because of their distinctive pluripotent feature, embryonic stem cells have a thorough potential to cure diseases such as cancer or Alzheimer. However, the biggest challenge of this study is to achieve differentiation by the embryonic stem cells into the targeted type of cells , without the risks of those cells changing into intrusive cells such as tumors.

The use of human embryonic stem cells is highly controversial because the stem cells are removed from an embryo at its first stage of development (known as blastocytes), leading to its premature destruction. According to Geron Corporation, the stem cells used in the preclinical studies were produced before the Bush administration banned the use of government grants to support research on new cell lines. The cells used for these researches come from unused embryos in specialized clinics where couples use in vitro insemination, and that would end up being destroyed and discarded.

The Bush administration banned the use of human embryonic stem cells for ethical and religious reasons, as well as for the respect of a human life. Nevertheless, Geron research as well as the FDA decision to approve embryonic stem cell research on human are legal and valid in respect to the Bush administration legislation to stem cell research. The new FDA approval could speed up a change in the legislation and regulation of stem cell research, promised by the Obama administration. Public interest in stem cells research reached its popularity when Superman actor, Christopher Reeve became paralyzed in a car accident in 1995.

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For more information, visit http://www.clinical-trials-info.com/

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