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/

The pharmaceutical and health-care industry have historically been relatively immune to economic turndowns, because illness doesn’t take a vacation. Yet, with the ongoing recession, financial support will be reduced. Therefore, like in other industries, it is expected that the most affected by the reduced availability in funding will be the early stage biotech and pharmaceutical companies who need funding. But is there more to come?

There are a few possible speculations.

1. There is a possibility that things will get worst due to the fact that the market will be so uncertain that no financial investors will be willing to back up any company with a risky profile, notably in regards to the early or short term investments. In the event of this scenario, all industries will be affected. Companies with little cash will go one by one, until the economy heals.

2. Investors are often reluctant to put their money into biotech and pharmaceutical companies because of other very attractive industries such as buyouts and investments in resources (mines, oil). As the economic crisis goes on, the opportunities for capital will decline further. Because of the known and well recorded risk profile of the biotech and pharmaceutical industry, investors are going to stay away and put their assets in sectors with none to low risks. However, exit routes also play an important role. Unless there is a fast return, there is only one way for a biotech/pharma company to be profitable: through acquisition by a larger biotech or pharmaceutical company. Because of the way biotech and pharmaceutical companies usually grow, this is highly likely to happen. In this scenario, smaller companies, unable to sustain their finance could potentially ask bigger biotech/pharma company to bankroll them, allowing the industry to survive and even grow.

As a matter of fact, that second hypothesis has already started to take place. With today’s economic turndowns, big drug companies are on a shopping spree. With the stock market prices tumbling, acquisitions are becoming cheaper. Also, struggling to find loans and capital, smaller companies are now more enticed to turn to the bigger ones to survive. Many big pharma companies, such as Bristol-Myers, GlaxoSmithKline or Wyeth, have been staring down billions worth of drug-patent expirations and many of them have few up-and-coming drugs to fill the blank. This economic crisis has given them exceptional opportunities to find bargains amongst the unfortunate small to medium companies in need for funding.

Nonetheless, it is important to remember that although the recession has yield great merges and acquisitions by the bigger biotech/pharma companies, the biotech and pharmaceutical industry is also very affected by the economic slowdown, and many of them are cutting jobs and closing factories. The belief of pharmaceutical and the health-care industry immunity to economic turndown is now on hold, and so is the hope for new medicine breakthrough.

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Finding money is becoming more and more challenging. However, some people hare using hidden resources to generate income.

Once mainly popular amongst students as an “easy and fast” way to make money, clinical trials are now becoming part of many everyday people’s lifestyle. Clinical research involves volunteers to testing new drugs. By doing so, they allow the gathering of data important to determine the safety and efficacy of the new drug, and its potential release on the market.

Some of the most reckless volunteers can bring up to $25,000 a year by participating in several clinical trials. After signing a consent form and passing the inclusion criteria, volunteers have to go to a clinical research center and undergo several tests such as checking vital signs, electrocardiograms, breathing tests, exercise tests, before and after receiving treatment. The treatment consist of a new investigational drug or can also be a placebo. Participants may have to give blood up to 5 times on a visit day at the clinical research center. Hence, volunteers who join many clinical trials may give blood up to 300-500 times throughout the year and may have tested about a dozen of new treatments or placebo.

The number of visits and hours allocated, as well as the pay per visit varies considerably between different trials and depend largely on the stage of the product development and the type of trial the volunteers are enrolled in. Therefore, participant may be paid between 50$ to 500$ for each session and each trial can last a few days to several months.  Each trial may include several consecutive visit days at the center and volunteers can also be asked to keep a diary between the visits, to assess any improvements or side effects due to the new medication. Volunteers are expected to be compliant to allow accuracy of the data, especially about safety and efficacy.  These data are particularly important to decide what are the next steps to be taken regarding the investigational drug, and if the product can safely be used on sick or younger patients.

This said, there is always safety concerns, especially at early stage of drug development, meaning side effects or drug reactions. However, possible side effects and the well-being of every subject are always a high priority for the pharmaceutical companies as well as for the investigators and staff conducting the trials. A participant may has the right to withdraw their consent at any given time, and this without any reasons.

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In conclusion, in these times of economic turndown, creative and new ways of generating money can be a big relief at the end of the month. Some people are now making their living of clinical trials and to those “lab rats”, in spite of the possible side effects, getting involved in trials is their new way to make sufficient income to pay the bills.