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Translational Trials Development and Support Laboratory (TTDSL)
Specialized Clinical Testing
The Translational Trials Development and Support Laboratory (TTDSL) is accredited by the College of American Pathologists (CAP). This accreditation documents that the laboratory not only meets Clinical Laboratory Improvement Amendments (CLIA) standards but exceeds them. TTDSL compliance with these standards assures that test results used for decisions in routine clinical settings and for clinical trial participant eligibility and monitoring are reproducible, objective, valid, and reliable.
The current assay compendium includes the following:
- Endotoxin by LAL
- Hematopoietic stem cell Colony Forming Unit enumeration and collection for further analysis
- Quantitation of VEGF-D in human serum for Lymphangioleimyomatosis (LAM) diagnosis
Clinical Assay Development
One of our mandates is to help investigators bring their specialized laboratory-developed tests to the clinic. We provide support in optimizing a Standard Operating Procedure (SOP), validating the assay at a level congruent with CAP regulations, and then offering the test through the TTDSL or in conjunction with another CCHMC clinical laboratory. Previous examples of this process include our Fanconi anemia complementation assay (now offered at the research level) and the VEGF-D assay.
Contact us to learn how we can help bring your assay to the clinic or prepare it for clinical trial use.
Clinical Trial Monitoring
The TTDSL has effectively supported 11 Phase I/II gene therapy clinical trials by designing tailored analytical assays and acquiring Sponsor-developed assays via Technology Transfer. We have extensive experience in providing the following services:
- Central laboratory coordination
- Peripheral blood leukocyte isolation, lineage sorting, and analysis by flow cytometry
- Vector copy number by qPCR
- Hematopoietic cell colony forming unit (CFU) assay
- Protein HPLC
- Gene expression by qPCR or flow cytometry
- Replication competent vector testing by qPCR (inquire for availability)
Although these techniques have been utilized primarily for lentiviral/retroviral vector monitoring, they can be developed for any vector system or even non-gene therapy clinical trials. Testing for Phase III clinical trials is possible if satisfied by compliance with CAP regulations. Contact us to find out how we can support your clinical trial.
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5. Ali AM, Kirby M, Jansen M, Lach FP, Schulte J, Singh TR, Batish SD, Auerbach AD, Williams DA, Meetei AR. (2009) Identification and characterization of mutations in FANCL gene: a second case of Fanconi anemia belonging to FA-L complementation group. Hum Mutat. 30(7):E761-70
6. Hartmann L, Neveling K, Borkens S, Schneider H, Freund M, Grassman E, Theiss S, Wawer A, Burdach S, Auerbach AD, Schindler D, Hanenberg H, Schaal H. Correct mRNA processing at a mutant TT splice donor in FANCC ameliorates the clinical phenotype in patients and is enhanced by delivery of suppressor U1 snRNAs (2010). Am J Hum Genet. 87(4):480-93