Mayo Clinic cleared to create larger batches of stem cells for clinical trials

Stem cells can be used to fight diseases or replace cells damaged by things like chemotherapy.

The Food and Drug Administration has cleared the way for Mayo Clinic to create larger batches of stem cells. The process by which they’re doing that is through an automated bioreactor-based stem cell production platform.

Dr. Guojun Bu, associate Director of the Center for Regenerative Medicine on Mayo Clinic’s Florida campus, said a stem cell has unlimited potential to make billions of cells.

“We can further push a cell to become any type of cell in your body. We can push it into any tissue or cell type in your body,” Bu said.

Patients who lost tissue from an injury or disease can possibly see their own cells healing the problem.

This clearance from the FDA enables the Mayo Clinic Center for Regenerative Medicine to produce cells from the bone marrow of a stem cell donor in quantities large enough to make several doses that can be used as treatments in clinical trials.

Through this advancement, stem cells can be produced within days instead of months. If more clinical trials are available to patients, this potentially could lead to physicians helping more people.

This automated stem cell production platform, capable of producing billions of stem cells in short periods of time, took more than four years to develop with continual oversight and evaluation by the FDA.

Stem cells that come from bone marrow have been shown to have many applications, including immune system modulation, reduction of inflammation and the promotion of healing in several tissues, such as bone, heart and brain.

Doctors are already using stem cells to treat some conditions. Bu said stem cells are also being used in clinical trials to repair a head injury or degenerative diseases, like Alzheimer’s disease.

“Imagine, someday we grow a little brain, part of the brain and put back to the patient who might have a stroke,” Bu said.

Bu showed Action News Jax stem cells that were reprogrammed genetically and showed those neurons firing, which resembles what you’d see in the human brain. Stem cell production has long been a labor-intensive process in which researchers cultivate hundreds of tissue-culture flasks over the course of months to produce enough cells for a few patients. However, the cells are needed on a large scale, such as for a recent Mayo Clinic clinical study that found infusions of stem cells to be safe for patients who have undergone lung transplants.

“The technology is there and it’s just a matter of time, and to ensure this is safe and someday start testing patients,” Bu said.

Mayo Clinic researchers are hoping to advance stem cell therapies in lung transplant rejection, chronic obstructive pulmonary disease and inflammatory bowel disease.

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