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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The Good Clinical Practice guideline stipulates that:

1. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and the applicable regulatory requirement(s).

2. Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.

3. The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.

4. The available non-clinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.

5. Clinical trials should be scientifically sound, and described in a clear, detailed protocol.

6. A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.

7. The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.

8. Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).

9. Freely given informed consent should be obtained from every subject prior to clinical trial participation.

10. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.

11. The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).

12. Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.

13. Systems with procedures that assure the quality of every aspect of the trial should be implemented.

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Reference:

(1) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

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