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20 June 2013

Ethical procedures of stem cell trials

Stem Cells are considered to be the basic building blocks of our body and are often referred to as Master Cells, having the potential to become almost any other cell.

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Stem cells are considered to be the basic building blocks of our body and are often referred to as Master Cells, having the potential to become almost any other cell.

The healing ability of Stem Cells is well documented with Stem Cell therapies and treatments being arguably the fastest growing sector in the medical field today, with over 70 diseases and disorders already successfully being treated.

 Some of the fatal diseases and disorders currently being treated with Stem Cells are: The Leukaemias, Lymphomas and other blood cancers, bone marrow disorders like Aplastic Anaemia and Sickle Cell disease.

 Recent successful transplants include the 4-year old boy who was successfully treated as part of the Cryo-Save Cost Free donation programme.  The boy’s condition, Blackfan-Diamond anaemia (BDA) received a stem cell transplant from his sister's umbilical cord blood.  

Stem cell therapies in future

The untapped potential of Stem Cell therapies lies in the future, with the field of Stem Cells having immense potential, offering possible solutions for a wide variety of health conditions. 

Currently there are promising results with cerebral palsy, traumatic brain injury, acquired hearing loss in children, spinal cord repair, diabetes, arthritis, blindness and even open wounds like burns and frost bite. With the inherent ability to modify into different cell types, Stem Cells are an obvious choice to use in trials involving these regressive and degenerative nerve conditions.

As a leading stem cell company, Cryo-Save had many samples which have been released for clinical trials at Dukes University in the USA. Cryo-Save also provides financial support to organizations that conduct research and clinical trials, including patients that have stored their Stem Cells with Cryo-Save.

Participating in clinical trials is an important means of validating treatment of a particular disease or testing a drug before it is introduced to the market in order to ascertain safety, effectiveness and to see if this trial offers a superior or new solution to what is currently on the market.

Approval of clinical trials   

Because these trials impact on the welfare and wellness of people, all clinical trials have a structured procedure and should be governed and regulated by a board such as the Federal Drug Administration (FDA).  Additionally all clinical trials should have ethical approval to ensure that no one is harmed and that best practices are maintained. Ethical approval can be granted by a specific hospital board in order to facilitate a small study.

“A higher level of approval enables people to gain a certain amount of comfort with regard to the validity of the research generated through the trial,” says Louis Rehrl, MD of Cryo-Save.  It is also advisable to include respected academics and professionals who are key players in the particular field undergoing research to further validate the trial.  For these purposes, Cryo-Save SA uses both SA and internationally based doctors, experts and international authorities.

“In this way clinical trials can be monitored so that the highest ethical standards are adhered to, in order to guarantee patients are not exploited,” concludes Rehrl.

 
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