Stem Cell Research at CBI
CBI conducts Stem Cell research, toxicology and efficacy studies for the biopharmaceutical, veterinary, and academic research organizations. As a premier Stem Cell Research CRO, our highly trained staff is experienced in the area of GLP contract research studies in stem cell toxicology, pharmacokinetics, biodistribution, combination device, radiolabel, pharmacology, histopathology, and immunohistochemistry.
Stem Cell Immunohistochemistry: Beta2 Microglobin positive human stem cells injected into nude rat.
Our scientists are well versed in the FDA requirements for Stem Cell Regulatory Packages, including recommendations on species selection, proof of concept studies, and duration of studies. Pivotal issues in Stem Cell research study design include clinical relevance, appropriate comparative anatomy and physiology, relevant clinical route of administration, and immune tolerance. Stem Cell Research toxicity studies are often conducted in the relevant disease model. Key comprehensive assessments include disposition and tolerability of the stem cells following injection, possible formation of ectopic tissues, teratoma-tumor formation, site reactions, and functional impact. CBI is also versed in stem cell-device or delivery combinations. We have conducted multiple CIRM-funded studies.
Our experience in Stem Cell Research includes, but is not limited to:
| Toxicity Studies | Efficacy Studies |
|---|---|
| Acute, Subacute, Chronic, Local Tolerability | Custom or functional studies (GLP or non GLP) |
| 1, 3, 6, 9, 12 and 24 month chronic | Ocular |
| Carcinogenicity and tumorogenicity | Carciopulmonary, intracardiac administration |
| Biodistribution | Diabetes |
| Radiolabel and PCR | CNS-brain, spinal cord |
| Histology | Oncology |
| Immunohistochemistry | Joint, bone, ligament and cartilage |
| Combination device and stem cell toxicity | Reproductive |
| Custom toxicity studies | Bone marrow |
Proposition 71, The California Stem Cell Research and Cures Initiative
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.
Proposition 71, the Stem Cell Research and Cures Initiative, is designed to turn the hope for those cures into reality, by using tax-free state bonds to fund stem cell research at California's 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 and appropriated $3 billion to finance this endeavor and established a constitutional right to conduct stem cell research.