Overview
| Experimental Hematology and Cancer Biology Translational Core Facility |
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The Experimental Hematology and Cancer Biology Translational Core Laboratory is relocating to an 11,000sq. ft. facility on the 11th floor of the newly constructed Location S Research Bulding. The new facility includes state-of-the art dedicated space for vector production, clinical cell manipulations, trial development, post trial monitoring and associated administrative and quality oversight activites. Click here for virtual tour. |
The safe and effective transfer of research technology from the laboratory to clinical practices requires specialized knowledge of regulatory oversight as well as scientific and clinical expertise. Maintaining a current knowledge-base in regulatory standards and their application to trial oversight has become increasingly burdensome for clinical and translational investigators. The Translational Cores in the Division of Experimental Hematology and Cancer Biology has been established to provide a common, well-versed resource for development, implementation, and monitoring of laboratory services and in guidance and oversight of regulatory compliance. The framework for this utilizes a Clinical Trials Development Plan to free investigators at Cincinnati Children's Hospital Medical Center from the technical burdens as much as possible.
The Vector Production Facility is designed to provide material for clinical trial development, and as a continuum, material produced for Phase I/II clinical trials. It has a state-of-the-art cleanroom facility used for cGMP manufacturing of products for a variety of types of early phase human trials. In addition, the facility will be used for the production of research grade viral vectors as part of the Viral Vector Core (VVC). The manufactured material may be analyzed for study suitability through well-coordinated efforts of the VVC and the Translational Trials Support and Development Laboratory (TTDSL).
| Supported By |
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 Experimental Hematology and Cancer Biology translational research is supported in part by a grant from the Charles H. Dater Foundation. |
The
Cell Manipulations Laboratory supports scale up and limited validation for somatic tissue processes for trial development and is then capable of transitioning these processes into a validated environment for cGMP cellular manipulations. This may include cellular transductions for gene therapy trials or other cell manipulations in support of hematologic or non-hematologic clinical trials and clinical trial development. The infrastructure, in coordination with Hoxworth Blood Center, is established to fully support Good Tissue Practice requirements. Services to investigators may range from cleanroom use only through full support of a trial. These are outlined on the
CML Menu of Services.
The Translational Trials Development and Support Laboratory (TTDSL) is organized to assure that the assay results used for decisions in vector and study development and for monitoring clinical trials are reproducible, objective, valid and reliable. The laboratory infrastructure as well as the assay SOP's meet Good Clinical Practice (GCP) requirements and have demonstrated this by achieving CAP/CLIA Accreditation. Current assays and services are listed on the TTDSL Compendium of Services include:
- Clonogenic assays for stem and progenitor cell function evaluations (includes drug resistance parameters if requested)
- Endotoxin and mycoplasma assays for product release testing or research screening
- Molecular and cellular measurements of transduction efficiency, vector titer, function
- Assays to control vector associated potential toxicities, including clonal contribution studies and general as well as locus-specific insertion site monitoring
- Fanconi Anemia Complementation typing by cell cycle analysis
- RCR/RCL Testing
- Research level bacterial/surgical sterility testing
- Hematopoietic cells for research from the Normal Donor Repository
A unique service for investigators is the expertise to adapt research level testing to SOP driven assays suitable for use in clinical trial safety and efficacy monitoring. The directors of the specific cores and the study principle investigators define the appropriate analyses and the TTDSL assures the sampling and analyses are performed using optimal methodologies and the appropriate level of regulatory compliance. For all preclinical and translational research and development studies, the TTDSL provides services documented to have followed a defined Standard Operating Procedure (SOP) with defined control materials. The Translational Research Trials Office (TRTO) supports investigator efforts in the development of early phase human trials that represent current science and innovative applications of cellular therapies and vectors. The TTDSL guides the investigator to assure comprehensive regulatory oversight from protocol development through study monitoring and data collection and reporting.
The Translational Cores interact extensively with the CCHMC clinical trials monitoring groups
as demonstrated by the flow diagram (37K .pdf document).
You can download the flow diagram in portable document format (.pdf). You must have Adobe Acrobat" Reader installed on your computer to read the .pdf files.
You can download Adobe Acrobat" Reader at Adobe's Web site by selecting the version appropriate for your computer.
For additional information, please contact Lilith Reeves, Division of Experimental Hematology and Cancer Biology, at 513-636-0364. The Division of Experimental Hematology and Cancer Biology can be found in room 7.205 of Location S(Research Foundation Building).
