Cranking up stem cell production for when therapies are approved for widespread use

Getting a cell therapy from the research bench to patients requires leaping many hurdles. Perhaps two of the highest arise when proving the potential therapy is safe enough to begin clinical trials and then when scaling up production to meet the demand of thousands of patients.

Scale up to producing the 100s of billions of cells needed to treat large groups of patients could be a roadblock for therapies.

Scale up to producing the 100s of billions of cells needed to treat large groups of patients could be a roadblock for therapies.

An even dozen CIRM-funded projects have made it over the first hurdle. No doubt those teams have begun planning for that last big jump, but in reality, in most cases the processes needed to make cells for a dozen or a few dozen patients in early trials don’t generally scale to the thousands. When you look at the number of cells needed for one heart repair, for example, around five billion, the numbers are mind bending.

Many organizations focus on this issue as their main goal looking for platforms that can help scale up production for cell therapies across many different diseases. A team at the University of Nottingham in England recently reported results from a $3.6 million project that seems to have created a sizeable piece of the solution. They developed a fully synthetic substrate, which has no chance for contamination, that can grow cells by the billion, both stem cells and the more mature cells normally desired for transplant into patients.

“The possibilities for regenerative medicine are still being researched in the form of clinical trials,” said the project leader Morgan Alexander in a university press release posted by ScienceDaily. “What we are doing here is paving the way for the manufacture of stem cells in large numbers when those therapies are proved to be safe and effective.”

The research team used a high throughput lab technique to test many materials until they finally arrived at the one they reported in the journal Advance Materials.

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