Translational Trials Development and Support Laboratory
The Translational Trials Development and Support Laboratory (TTDSL) has been established to provide laboratory services that comply with Good Clinical Practice (GCP) standards. Compliance with these standards assures that the assay results used for decisions in study development and for clinical trial participant pre and post trial eligibility, safety and efficacy are reproducible, objective, valid, and reliable. Many of these assays are applicable for non-clinical research and may be adapted to support basic research as well. A listing of assays currently available is provided on the Clinical or Research Sample Submission forms in the Forms Link above. The TTDSL has the ability to develop most investigator specific research tests to SOP level assays that meet GCP requirements.
The TTDSL assays include cellular and molecular testing categorized as follows:
- Endotoxin
- Fanconi Anemia Complementation typing
- Clonogenic assays (+/- presence of drugs) for enumeration and function
- DNA/RNA Extraction and Quantitative PCR for select vector or genomic sequences
- Clonal contribution studies including vector insertion site analysis and sequencing (LAM PCR)
- Bacterial and Fungal Sterility (Research Only)
- Normal Donor Hematopoietic products
- Transgene detection and function assays
- Insertion site analysis (LAM and LM)
- Mycoplasma
- RCR/RCL
- Viral Vector Titration
The laboratory has significant expertise in assays to detect, quantitate, and sequence insertion sites, including molecular detection and tracing of stem cell activity and lineage specific repopulation, surveillance for potential oncogene activation, and other specific molecular safety and efficiency concerns. The Fanconi Anemia Complementation Assay is developed from research done in the David Williams' Laboratory in collaboration with Arleen Auerbach and Helmut Hannenburg and is based on cell cycle arrest correction with complementing retroviral vectors. Assay systems for transplant function and specific transgene correction, including quantitative RNA and DNA molecular analysis, have been developed as a cost-saving modular system that can be combined economically according to the specific needs for each project. The laboratory has the ability to modify research level molecular, cellular, and protein expression testing to SOP driven assays appropriate for support of clinical trials.
The TTDSL is accredited by the College of American Pathologists (CAP). The accreditation documents that the laboratory not only meets Federal Clinical Laboratory Improvement Amendments (CLIA) requirements, but exceeds them. CAP has the authority of the Centers for Medicare and Medicaid Services (CMS) to accredit all CLIA specialties and subspecialties. CMS is also recognized by the Joint Commision on Accreditation of Healthcare Organizations (JCAHO) as an equivalent program in JCAHO-accredited institutions.
The Translational Trials Development Support Laboratory is supervised by Jose Cancelas, MD; Lilith Reeves, MS; Elke Grassman, PhD; Michelle Kirby; and Christof von Kalle, MD.
For further information regarding the Translational Trials Development Support Laboratory (TTDSL), please contact Lilith Reeves, MS, at 513-636-3468. For additional information about the Division of Experimental Hematology and Cancer Biology, please contact Yi Zheng, at 513-636-0364. The Division of Experimental Hematology and Cancer Biology can be found on Level 7 of Location S(Research Foundation Building).
