The researchers suggest this area
holds promise for applications in regenerative medicine, but there are still a number of major hurdles in the path of stem cell research today preventing the routine application of the technology in regenerative medicine. They pointing out that technical and ethical problems remain to be addressed and discuss the issues of how to patent stem cell discoveries and make them commercially viable (right: The global stem cell patent landscape. Courtesy:www.nature.com)

Stem cells are immature cells that can replicate rapidly and mature into the different cells needed around the body to build tissues in the skin, liver, heart, bone, brain, blood cells, nerves. They are present only in limited quantities in adults but are present in huge numbers in embryonic tissue. Human embryonic stem cells are currently the most promising source for therapeutic purposes, but their use has ethical implications.

Stem cell research holds great promise in medicine. Advocates hope that the work will lead to important therapies for tackling major degenerative diseases, such as Parkinson's, Alzheimer’s, stroke, heart disease, diabetes, cancer and arthritis. There are also the possibilities of using stem cells to treat debilitating injuries of the spinal cord and other structural injuries. In addition stem cells will have applications in discovery and testing new drugs.

The recent case of the trachea engineered to avoid organ rejection by using a patient's own stem cells is a prominent and early inspirational success.  Surgeons in Spain carried out the world's first tissue-engineered whole organ transplant which scientists from Bristol helped grow the cells for the transplant - using a windpipe made with the patient's own stem cells, after tuberculosis damage threatened a lung. The European team believes such tailor-made organs could become the norm

"Technical solutions may involve the use of human embryos and this has created barriers to the use of the technology in a number of countries," say Bower and colleagues. "There is already a need for the progressive development of appropriate legal and regulatory frameworks to allow both the scientific and clinical research to move forward. Although public acceptability of the technology is by no means universal, it does not at present appear that therapeutic applications are likely to meet with wholesale rejection."

The researchers explain that while there remain technical obstacles to be overcome in stem cell research, Western scientists are not the only ones working on advancing this field. Scientists in China, South Korea, and India are also taking steps forward, although revelations of scientific fraud have led to negative publicity.

But the team believes that if a high level of routine success were achieved outside the West, this might have a belated positive impact on the public demand for stem cell therapies in the West, creating the political pressure necessary to address the regulatory, legal, and ethical issues sooner rather than later.

The caveat, of course, being that if such success is achieved outside the West, the chances of the West ever catching up or overtaking to lead on such developments will be considerably lessened.

Scottish software for tissue bank compliance
The UK based human tissue bank, Future Health has chosen Q-Pulse, a compliance management solution from Scottish software developers Gael Ltd, to manage its Quality Management System (QMS) and maintain and improve its compliance with the requirements of strict UK and EU regulations.

Based in Nottingham, England, Future Health (right) collect, process and store stem cells derived from umbilical cord. As a private family cord blood stem cell and tissue bank, Future Health is licensed by the Human Tissue Authority (HTA).

Q-Pulse provides tissue establishments like Future Health with a fully integrated compliance management solution that helps manage regulated activities including Document Control, Auditing, and CA/PA Management, in compliance environments such as cGMP, 21 CFR Parts 11 and 1270-1271.

"As a result of the company’s growth, this has led to an increase in the number of Scientific Officers employed at Future Health, as well as a corresponding increase in the number of SOPs currently in operation," 
says Beverley Lancashire, Chief Scientific Officer at Future Health.

 "All of our Scientific Officers must be fully trained and competent in all procedures with evidence of continuous training. The company therefore decided that Q-Pulse was the way forward in assuring our clients and regulatory authorities, including the HTA and MHRA, of our compliance with rigorous UK and EU regulatory requirements.

"Having observed Q-Pulse in operation at Derby Royal Infirmary, our QA Manager and I had both been very impressed with how Q-Pulse worked for them. After reviewing several other options, management at Future Health decided that Q-Pulse was the most suitable to maintain and improve the Quality Management System implemented at the company.

‘We currently store more than 22,000 stem cell samples derived from umbilical cord blood from 35 different countries, and have seen demand for our services increase year-on-year. At Future Health, we believe that implementing Q-Pulse will help us in maintaining the highest possible standards for private cord blood banking.’

Source: http://tinyurl.com/69aoh5
http://www.gaelquality.com/
Webs:http://www.genomicsnetwork.ac.uk/innogen/
http://www.futurehealth.co.uk
http://www.cells4life.co.uk/