Interview with Gerhard Bauer, Director of the GMP Laboratory 3/5/13
Can you tell us some background information about what you do?
I am the director of the Good Manufacturing Practice (GMP) laboratory at the UC Davis School of Medicine. My lab manufactures clinical grade products, in particular stem cell, gene therapy and other cellular products for patients enrolled in clinical trials. A GMP facility is an ultra clean laboratory that operates under Federal mandates (21CFR 210 and 211) to assure the manufacturing of clean, uncontaminated and potent products for administration into patients. I designed and built the GMP laboratory at UC Davis, which is currently the largest academic GMP facility in Northern California.
Are there any projects you are currently working on?
There are many projects I am working on currently; to mention just a few, we are manufacturing stem cell products for the treatment of retinal ischemia (blindness induced by too little blood flow in the retina of the eye), the first clinical trial of this kind in the US, which UC Davis initiated. We are manufacturing a mesenchymal (adult) stem cell product for the treatment of Huntington's disease, an inherited neurodegenerative disease, for which there is no treatment available at all. This clinical trial will be another first in the United States. Mesenchymal stem cells are also manufactured for the treatment of critical limb ischemia, which is a disease of too little blood flow in the legs; many diabetics can get this disease, and sadly, many need to have their legs amputated. We hope that we can treat critical limb ischemia with these stem cells and save limbs so they don't need to be amputated.
How can stem cells be applied to current diseases?
See paragraph above, treatment of ischemic retina, Huntington's disease and critical limb ischemia.
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Is there any relation between stem cells and HIV?
The target cells for HIV are CD4+ T lymphocytes, macrophages, dendritic cells and even brain microglial cells. All of these cells originate from bone marrow stem cells, which are also called hematopoietic stem cells, since they make all cells of the blood. A cure for HIV could be demonstrated in a person with HIV when all of the bone marrow stem cells of that person were replaced with stem cells that carried a natural resistance gene to HIV. This person received a bone marrow transplant from a bone marrow donor that was naturally resistant to HIV. The person that received these HIV resistant bone marrow stem cells has been free of HIV to this day. We are hoping that we can mimic this bone marrow transplant by adding anti-HIV genes into the bone marrow stem cells of patients that are HIV infected to also make them resistant to HIV.
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What is stem cell therapy?
Stem cell therapy is the application of stem cells to treat or cure diseases.
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What are the pros of stem cell therapy?
There are several types of stem cell therapy: Adult type stem cell therapies that use stem cells that can be found in a person's body, which have specialized functions and can only make certain tissues, for instance the blood forming bone marrow stem cells. Such cells can also be used to regrow blood vessels, for therapies that have been described above (ischemic retina, critical limb ischemia). There are also therapies that use pluripotent stem cells, these stem cells can make all cells and tissues of the body, including nerve cells. Such stem cells have the potential to replace damaged nerve tissue, for instance, they could make a paralyzed person walk again.
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What are the cons of stem cell therapy?
Adult stem cells have very few cons, they have been used in many thousands of patients and have shown excellent safety. Pluripotent stem cells have the ability to make all tissues of the body; if they are not completely removed from a tissue that will be transplanted they could potentially form a cancer.
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Will the general population see stem cells in their everyday lives, say ten years from now?
The general population has been seeing stem cell therapies in their lives since 1956. This was the year when the first bone marrow transplantation to save a person from leukemia was performed. Bone marrow transplants are being performed daily. What really is therapeutic component in a bone marrow transplantation is the bone marrow stem cell, allowing to grow back the blood and immune system of the donor in the recipient. The new immune system detects the cancer cells and kills them, leading to an 80% cure rate for leukemia. Current applications of stem cell therapies are regenerative therapies for the repair of tissues, as described above.
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What do you believe is the most controversial side to stem cell research?
This might be the application of pluripotent stem cells called embryonic stem cells, as these stem cells would be from a 4-5 day old embryo. However, such stem cells have only been created from discarded embryos for in vitro fertilization procedures; such procedures are standard practice all over the country. Instead of discarding these embryos, they were used to derive pluripotent stem cell lines that could potentially help thousands of people, as they are able to regrow nerve cells, liver cells, heart cells, etc. This needs to be kept in perspective.
INTERVIEW 2
Gerhard Bauer, Ph. D
Assistant Adjunct Professor, Laboratory Director, GMP Facility
UC Davis Institute for Regenerative Cures (IRC)