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December 03, 2014

Driving Down the Cost of Stem Cell Manufacturing

If stem cells are to be used routinely in drug discovery and therapeutic applications it is essential that cell production becomes easier and more affordable.

Driving Down the Cost of Stem Cell Manufacturing

3D polystyrene and polypropylene scaffold used in a bioreactor to culture Pluristem’s placenta-based stem cell product, PLX. [Pluristem]

  • In the week that cell therapy firm, Dendreon filed for bankruptcy, speakers at the London Regenerative Medicine Network (LRMN) meeting at University College London (UCL) continued to make compelling cases for the routine use of stem cells in drug discovery and regenerative medicine. “Traditional medicines in use today cannot address many conditions effectively,” explained Gil Van Bokkelen, Ph.D., chairman and CEO of cell therapy firm Athersys. “In the U.S. alone we’re spending $250 billion dollars annually to treat diabetes, cardiovascular, neurological, pulmonary, and kidney disease yet the treatment is not always effective and quality of life is often poor. For example, if you have a heart attack, the chance of having chronic heart failure within five years is high.”

    According to Dr. Van Bokkelen in the next 20 years there will be 80% more people over 65 years old in the U.S. (more than 72 million people by 2030, up from 40 million in 2010). In Japan, this will be most visible as more than 30% of their population will be over age 65 by 2030. Healthcare costs increase dramatically with age and can be up to 5 to 10 times more annually among the elderly because this is when conditions such as stroke, cancer, and heart disease become more prevalent.

    “The aging population coupled with the shortage of trained doctors means we are facing the Mount Everest of healthcare in terms of spending and lack of treatments. The public are under the misconception that it is expensive new drugs that are the cause of increased healthcare spending but in fact only 10 % of the U.S. healthcare budget goes toward prescription medicines, while a far greater amount is devoted to supportive or  palliative care (hospital care, nursing homes and physician services) to care for those that can no longer care for themselves,” Dr. Van Bokkelen said.

    The use of stem cells as a regenerative tool could be more effective than current treatment regimes as Dr. Van Bokkelen stated: “Cells are able to do things in a dynamically regulated way, and their multi-modal nature is the power behind their effectiveness.”

  • Repairing the Damage

    Click Image To Enlarge +
    Manufacturing of Pluristem’s placenta-based stem cell product, PLX in a bioreactor using a 3D polystyrene and polypropylene scaffold. [Pluristem]

    As an example of how stem cells can be used in regenerative medicine to treat post-stroke damage, Dr. Van Bokkelen presented information on MultiStem®, a cell therapy that is manufactured from human stem cells obtained from adult bone marrow or other non-embryonic tissue sources. He showed that in preclinical rat models, MultiStem dramatically down regulates inflammatory proteins thought to cause damage post-stroke and up regulates neurotrophic factors, which promote repair. “Even when we inject MultiStem one day after the ‘stroke’ there is a profound difference in the up- and down regulation of these proteins. This is encouraging as only around eight percent of stroke patients get tissue plasminogen activator within the four- hour effective treatment window, and this means many people that have a stroke suffer irreparable damage,” Dr. Van Bokkelen noted.

    Currently, Athersys is running a clinical trial with 140 patients at stroke centers in the U.K. and U.S. MultiStem is being administered intravenously one- to two days after a stroke has occurred, where published preclinical results have shown substantial benefit even when the cell therapy is administered up to a week after the stroke. The firm aims to announce results from this Phase II trial in early 2015, around the end of the first quarter.

    Zami Aberman, chairman and CEO of Pluristem Therapeutics, a developer of placenta-based stem cell products also presented positive data on how its PLX (PLacental eXpanded) cells are being used in orthopaedics to help improve muscle repair post hip replacement surgery. “We treated 20 patients with 150 x 106 and 300 x 106 PLX cells and they demonstrated up to 500 percent improvement in their MVIC (maximal volitional isometric contraction), a standard measure for hip movements up to 26 weeks post operatively,” Aberman explained.

    Aberman also discussed how PLX cells are being used to treat hind limb ischemia. He presented pre-clinical data to show that mice injected with PLX had an improved blood flow to their affected leg. He presented clinical data from a two dose-escalating, Phase I/II study in which 27 patients suffering from critical limb ischemia injected with 150-600 x 106 PLX cells showed a risk reduction of limb amputation of 59%, 12 months post-treatment, compared to patients that did not receive the cells. “When we first made stem cells from placenta ten years ago, everyone said this was not a good source of cells for regenerative medicine. Now the miracle of birth is helping to produce some really promising therapeutics,” Aberman said.

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