Technical Sessions

Technical Session 1: Imaging Cell Therapy
Thursday 5/19/2011
Time: 7:45am - 8:45am

The possibility of isolating and expanding stem cells and of driving them towards various phenotypes have motivated exploration and development of stem cell based therapy. In order to understand the mechanism, and to improve the efficacy of these treatment approaches, the monitoring of the fate and biodistribution of the transplanted cells is necessary. The current non-invasive techniques of the in vivo tracking of stem cells include direct labeling with magnetic particles for magnet resonance imaging or radionuclides for scintigraphic or positron emission computer tomography (PET), and indirect labeling with reporter genes, such as PET, fluorescence, or bioluminescence reporter gene methods. The present session summarizes these techniques, mentioning their particular advantages and usefulness under experimental and clinical conditions in the context of bone and cardiac tissue engineering.

Technical Session 2: Practical Considerations in Cell Selection for Cellular Therapy
Thursday 5/19/2011
Time: 7:45am - 8:45am

Cell selection methods for cellular therapy are generally first optimized for use in small animal models. In most cases cell selection involves magnetic particle cell sorting, high-speed droplet sorting, or a combination of these two technologies. Each technology requires optimized cell labeling protocols to reliably obtain the cell population of interest.  In preparation for clinical trials these methods often need changes to accommodate testing in humans. Moreover, the increasingly complex phenotypic description of therapeutic cell populations has made high-speed droplet sorting the cell selection method of choice in many research settings. High-speed droplet sorting in particular brings a series of challenges when used in the clinic, presenting investigators with the dilemma to either overcome the challenges or to switch to magnetic particle cell sorting. This session is also intended to facilitate sharing information about what works and what doesn’t in cell selection methods for cellular therapy in the clinic. Topics to discuss include: scaling up (antibody usage, duration of the process), logistics, clinical grade antibodies, sterility, controls, safety and regulatory requirements.

Technical Session 3: Potency Assays in stem cell based therapeutics
Friday 5/20/2011
Time: 7:30am - 8:30am

A biological measurement of the activity of a cell product is the most critical step in the product release for both clinical trials as well as market-placed products.

The session will present you some intriguing applications of two of the most popular techniques currently used for cell product characterization: flow cytometry and microarray analysis. Dr. de Boer will present a biopotency assay on mesenchymal stromal cells used for bone tissue engineering. In fact, large differences exist in bone forming efficacy between MSCs isolated from different donors, but no proper in vitro marker is known which predicts the in vivo bone forming capacity of a given donor. He will present the use of microarray analysis to correlate the in vitro gene expression profile of MSCs of different donors with their potency to form bone in an immune-deficient mouse model and identified CadM1 as a highly predictive classifier. The presentation by Dr. Moro will give you a general overview on how to use flow-cytometry to identify the phenotypic characteristics that corresponds to the target functional stem cell population. Examples will be given in the context of hematopoietic as well as mesenchymal stem cell applications.

Technical Session 4: ES/iPS Cells
Friday 5/20/2011
Time: 7:30am - 8:30am

Two kinds of pluripotent stem cells exist, embryonic stem (ES) cells and induced pluripotent stem (iPS) cells, which are somatic cells that acquired pluripotency by the expression of specific factors.  Since these cells can be maintained in culture indefinitely without losing the ability to generate all cell types of a human body, they provide unique opportunities to regenerative medicine, fundamental research and drug or toxicity testing. In addition, the unlimited self-renewal features allow the establishment of banks of pluripotent stem cell lines covering most frequent haplotypes. In this session an overview of the latest progress on the use of iPS cells for treating blood disorders, and on the banking of pluripotent stem cells for research and clinical purposes will be presented.

Technical Session 5: Adipose Mesenchymal Progenitors
Saturday 5/21/2011
Time: 7:30am - 8:30am

The greatest interest of adipose tissue as a source of therapeutic cells is the fact that there is no ethical concern about this source since it is obtained from an adult, is abundant and easy to get tissue, even when compared with bone marrow, sampling of which requires more invasive technique. Another advantage is that, as the frequency of Adipose Derived Stromal Cells is much higher in adipose tissue than those of MSC in bone marrow, a large number of cells can be obtained without a large number of passages. In this way, the risk of culture-induced chromosomal abnormality senescence is largely decreased. On the other hand, a key step in the process of isolation of adipose derived immature cells is the digestion of the tissue and the choice of protocols that can lead to isolate different cell subsets. This step and the need of the adequate protocol for their in vitro culture expansion is crucial for the security and the efficiency of their therapeutic uses. This session deals with these different points that represents a key stake for adult stem cell based regenerative medicine.

Technical Session 6: Ancillary Materials
Saturday 5/21/2011
Time: 7:30am - 8:30am

Quality of the components used in the manufacturing of cellular or tissue-based therapies will have great impact on the quality of finished products. Examples of these components include the source cells and tissues, biomaterials, ancillary materials, and excipients used in the formulation of cellular or tissue-based therapies. Ancillary materials are biological/biochemical substances which play an important role in the manufacture of cellular therapies and also in the manufacture of other therapeutics using living cells in their processes. To ensure quality of finished goods, it is important that qualification programs are in place, for the assessment of these ancillary materials. The scope of this session is to highlight the different quality aspects that relate to the manufacture of somatic cell therapy and tissue-engineered products, including a discussion on how the performance of reagents can be evaluated through the use of materials with acceptable test specifications.