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Dev

Clinical trial support

The TransLab offers a comprehensive battery of cellular and molecular assays to help guide personalized therapy or support patient monitoring. We can assist with simple, routine processes as well as complex, non-routine laboratory developed tests. Our goal is to support your specific clinical research needs whatever they may be and we have significant experience in developing new assays and/or transferring assays from a research laboratory context into a validated format for clinical trial support.

Below are some examples of previously performed assays the TransLab has used to support clinical trials:

  • Density gradient separation & cryopreseravation of mononuclear cells
  • Large-scale cell selection (CliniMACS®) from mobilized peripheral blood or apheresis products
  • DNA and RNA extraction
  • Flow cytometry-based immunophenotyping, cell population isolation and functional assays (cytotoxic assay, proliferation, apoptosis)
  • Molecular assays: PCR, qPCR, cloning, RNA Seq library preparation, Southern blot
  • Predictive, prognostic or PD biomarkers analysis using plate-bound immunoassays: ELISA or multiplex immunoassay (Luminex MAGPIX®)

Examples of the type of support for phase I/II trials we are currently providing.

  • Molecular monitoring of patients enrolled in clinical trials
  • Biomarker profiling by ELISA
  • Phenotypic and functional cellular assays to evaluate alloreactivity in a haplo transplant setting
  • Immunomonitoring studies

The TransLab has deep experience working on a diverse pipeline of projects covering the fields of cancer therapy, regenerative medicine and gene therapy. As of today, the TransLab has enabled 11 clinical trials. Some notable examples include:

Cancer therapy

  • Allogeneic unrelated umbilical cord blood, expanded with PGE2
  • Epstein-Barr virus specific T cell therapy for nasopharyngeal carcinoma
  • In vitro expanded autologous invariant natural killer T cells in cancer
  • MART1-specific CTLs for melanoma
  • Use of regulatory T cells and IL-2 to treat steroid-refactory chronic graft verus host disease

Regenerative medicine

Cultivated Autologous Limbal Epithelial Cells (CALEC) use of lung derived mesenchymal progenitor cells for the treatment of advanced emphysema.

Gene therapy

There are exciting new developments in the field of autologous transplant of genetically modified hematopoietic stem/progenitor CD34+ cells. The TransLab has played a key role in the development of clinical trials for several genetic deficiencies:

  • X-linked Severe Combined ImmunoDeficiency (X-SCID)
  • Wiskott-Aldrich Syndrome (WAS), X-linked Chronic Granulomatous Disease (X-CGD)
  • Childhood Cerebral Adrenoleukodystrophy (CCALD)

Process and product development

We provide an integrated process and product development platform that delivers:

  • Robust and validated cell manufacturing procedures
  • Product-specific characterization profile with product release target specifications to ensure product safety, identity, purity and potency
  • Post-manufacturing logistics: final formulation, packaging and shipping
  • Standard Operating Procedures (SOP) and Batch Production Record (BPR)
  • Regulatory support, including generating the Chemistry, Manufacturing, and Controls (CMC) section of the Investigational New Drug (IND) application, help answering product manufacturing and characterization questions in the clinical protocol
  • Technology transfer to GMP manufacturing facility