March 2009    

Stem Cell Research and the Capabilities at CBI
Carol Meschter, DVM, Ph.D., DACVP

Over 128 million Americans suffer from diseases and injuries that could be treated or cured with new stem cell therapies. These devastating medical conditions affect children or adults in nearly half of all families. In fact, nearly everyone has loved ones or friends whose lives could be saved if adequate funding is made available to develop stem cell cures. This article discusses the current status of Stem Cell Research and the research capabilities that Comparative Biosciences, Inc. (CBI) offers.

Federal and the State of California Stem Cell Research Status

In January, 2009, the FDA cleared Geron's application to conduct first ever early-stage clinical trials on its stem-cell based therapy, aimed at treating severe spinal cord injuries. A successful clinical trial will revolutionize stem cell research on a worldwide basis. With President Obama in office, there is hope that he could lift or ease restrictions on federal funding very soon. Additionally, House Speaker Nancy Pelosi has expressed interest in pressing the case if the administration doesn't act in the first 100 days of the new Congress.

In California, Proposition 71, the Stem Cell Research and Cures Initiative, is designed to turn the hope for stem cell cures into reality, by using tax-free state bonds to fund stem cell research at medical research facilities. Since August 9, 2001, when President Bush decided to limit federal funds for human embryonic stem cell (HESC) research, much debate has surfaced about the future of this type of research. In California, Proposition 71, The California Stem Cell Research and Cures Initiative, was passed in November 2005 in response to these federal funding limitations. This bond initiative established the California Institute for Regenerative Medicine (CIRM), a California analogue for the National Institute of Health, to regulate stem cell research and funding appropriated $3 billion to finance this endeavor and established a constitutional right to conduct stem cell research.

Stem Cell Studies at CBI

At CBI, we are experienced in stem cell research particularly in the area of GLP regulatory studies, toxicology, pharmacokinetics, radiolabel, and pharmacology, as well as histology and immunohistochemistry. Our scientists are versed in the FDA requirements for stem cell packages, including recommendations on species selection, proof of concept studies, appropriate sized groups, and duration of studies. Clinical relevance, appropriate comparative anatomy and physiology, relevant clinical route of administration, and immune tolerance are pivotal issues in stem cell study design. Key comprehensive assessments include disposition of the stem cells following injection, possible formation of teratoma, ectopic tissues, tumor formation, site reactions, and functional impact. We have complete facilities for housing and handling immunocompromized animals, a tissue culture laboratory, procedure rooms, necropsy, and complete histology and immunohistochemistry. Our scientists and biologists are experienced in working both stem cells and the species used to assess toxicity and efficacy.

Our experience in stem cell research includes, but it not limited to:

Toxicity Studies

Efficacy Studies

Acute, Subacute, Chronic, Local Tolerability

 Custom or functional studies

 6 month- 2 year Chronic

 Myocardial infarction








 Tissue injury, joint injury



To learn more about Stem Cell Research at CBI, or to discover our additional preclinical service offerings, go to www.compbio.com.


“Key Facts About Proposition 71.” Yes on 71: California Stem Cell Research and Cures Initiative. <http://digital.library.ucla.edu/websites/2004_996_027/facts.php.htm>

About the Author

Carol Meschter, DVM, Ph.D., DACVP
Dr. Meschter is a founder of Comparative Biosciences, Inc. Previously, she was in the Investigative Toxicology Group at Hoffmann-LaRoche in Nutley, NJ, and was the Director of the Research Animal Facility at the American Health Foundation in Valhalla, NY. As a board-certified veterinary pathologist, Dr. Meschter brings fifteen years of experience in the pharmaceutical industry, primarily in toxicology, pathology, preclinical development, discovery support, and preclinical pharmacology. She is knowledgeable in early phase drug development from discovery to NDA, with technical expertise in pathology, pharmacology, efficacy modeling, and pharmacokinetics. She is a scientific editorial reviewer for Toxicologic Pathology, Veterinary Pathology, AVMA Journal, AJVR, J Applied Immunology, and has over 100 publications.