Stem Cell Research Experience

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. We have experience with both small molecule and large molecule/biologic therapeutics.

Stem Cell 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

  • Acute, subacute, chronic, local tolerability
  • 1-, 3-, 6-, 9-, 12- and 24-month chronic
  • Carcinogenicity and tumorogenicity
  • Biodistribution
  • Radiolabel and PCR
  • Histology
  • Immunohistochemistry
  • Combination device and stem cell toxicity
  • Custom toxicity studies

Efficacy Studies

  • Custom or functional studies (GLP or non-GLP)
  • Ocular
  • Cardiopulmonary, intracardiac administration
  • Diabetes
  • CNS-brain, spinal cord
  • Oncology
  • Joint, bone, ligament and cartilage
  • Reproductive
  • Bone marrow