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IDEA Report Summary

Project ID: 279288
Funded under: FP7-HEALTH
Country: Germany

Periodic Report Summary 3 - IDEA (Identification, homing and monitoring of therapeutic cells for regenerative medicine – Identify, Enrich, Accelerate)

Project Context and Objectives:
Identification, Enrichment and Acceleration (IDEA) are objectives in the field of regenerative medicine towards meaningful new therapeutic procedures. Establishing regenerative medicine in the clinic is currently hampered by several limitations that are associated with the complex process of the therapeutic intervention that characterizes this innovative medical approach: harvesting of progenitor cells from donors, identify, separate and clone them under GMP condition, transfer them to the recipient and monitor the therapeutic and possible side effects. The IDEA project is dedicated to develop new tools for regenerative medicine. Namely, to develop new photonic methods that allow a contact and marker-free identification and selection of cells prior transplantation, develop and test devices and tracer for homing, capturing and monitoring of such cells in vivo and to guide therapeutic interventions of regenerative medicine by applying new imaging techniques. The latter is a prerequisite to a meaningful performance of a clinical study.
The scientific and technological objectives of IDEA are encouraged by the established clinical practice for hematopoietic stem cell transplantation in patients with life-threatening malignant and non-malignant diseases. An estimated 45,000 to 50,000 hematopoietic cell transplants (bone marrow, PBSC, or cord blood transplants) are performed annually worldwide and has become a standard of care for some diseases as well as a newer treatment option for others. Clinical experiences with hematopoietic cell transplantation revealed the needs before expanding cell transplantation beyond the borders of current clinical practice: (1) a better identification of appropriate cells with healing potential, (2) more efficient homing of these cells to the injured tissue, and (3) a meaningful non invasive monitoring of the therapeutic effects.
IDEA is using a multidisciplinary approach that combines academic, clinical and industrial expertise to comprehensively tackle the complex parameters required for development and evaluation of new tools, technologies and devices for regenerative medicine.

Project Results:
During the second period the IDEA consortium has progressed on many fronts. The following results were achieved:
• A demonstrator for photonic measurements of living cells, the BioRam®-System, was set up for the identification of cells with healing potential and introduced to scientists and industry. Raman spectra of numerous samples from different origins have been measured to learn more about best preparation and handling methods of cells and tissues as well as to find biological relevant statistical analyzing procedures. The BioRam®-System was presented on various scientific workshops and industrial fares during period 2.
• More than 30 different iron oxide nanoparticles with different iron cores and various coatings were synthesized and screened concerning the following characteristics: ingestion into cells, cytotoxicity, magnetic and in vivo behavior. We selected two prototypes for further developing as imaging tracer for regenerative medicine regarding their potential for cell labeling and in vivo tracking using Magnetic Resonance and Magnetic Particle Imaging (MRI and MPI).
• A prototype of a magnetic device for transporting and carrying stem cells through the body of living animal and men were designed and constructed based on a sequence of NdFeB magnets and ferromagnetic rings. The rings were coated with gold to provide surface resistance and biocompatibility. The prototype of this device was tested under simulated in vivo situations and using our iron oxide nanoparticle prototypes that were incorporated into human mesenchymal stem cells (huMSCs).
• A demonstrator for Magnetic Particle Spectroscopy (MPS) has been developed that allow assessing stem cell vitality in vitro. This prototype was presented on various scientific workshops and industrial fares during period 2. A prototype of a Magnetic Particle Imaging (MPI) system for in vivo measurements has been constructed based on the know how from MPS. This MPI system is suitable for non invasive monitoring of therapeutic effects related to stem cell transplantation in vivo and will be tested during the remaining project time.
• Sourcing, culturing and expansion of potential cell types with healing capacity, such as pericytes, MSCs as well as aNSCs were established and procedures for the isolation and cultivation of MSCs and ECFCs from rat, mice and different human donors were customized. Two neural stem cell lines (CTX0E03 and CTX0E16) for comparison of trophic factors were prepared for the measurement using the BioRam®-System. For future transplantation approaches, procedures to enhance neuronal commitment and function via TGF-beta priming of aNSCs were developed. Since neuroinflammation is a prevalent component of Alzheimer’s and Parkinson’s disease, procedures for the isolation and cultivation of primary microglia cells, as well as for the expansion of microglia cell line (BV-2) were established to characterize microglia subtypes and their activity during regenerative processes.
• Different animal models of diseases were set up to allow the evaluation of stem cell transplantation. For studying Alzheimer’s disease the 3xTg-AD model has been set up and a colony is being established prior to aging before behavioral testing and transplantation. The contribution of stem cells originating from the adventitia to neointima formation was evaluated. Adventitial cells with an MSC-like immunophenotype migrate to the intima in response to vascular injury. Some preliminary results indicate that implantation of bone marrow CD34+ cells prevent restenosis after vascular injury in a murine model of femoral angioplasty. Models of Parkinson’s disease and spinal cord injury have been set up.
Management, coordination and dissemination tools are in place to support the various scientific and technological tasks of IDEA.

Potential Impact:
IDEA is a 60-month collaborative project addressing the objectives of the HEALTH priority of the European Commission under FP7. Specifically, new tools for regenerative medicine will be developed that include techniques for the culturing, isolation and multiplication of stem cells, photonic measurements of stem cells for their identification prior transplantation, new tracers that allow tracking of stem cells after transplantation, medical devices for homing of stem cells, and imaging protocols for non invasive monitoring of therapeutic effects after stem cell transplantation.
The IDEA project has established a collaboration between scientists and clinicians from Karolinska Institute (Stockholm, Sweden), Kings College (London, UK), Paracelsus Medical University (Salzburg, Austria) and Julius-Maximilians-University (Würzburg, Germany) together with experts from SMEs specialized in photonic technologies for tissue engineering (CellTool), medical device manufacturing with extensive experience in regulatory approval (CMI), the design, synthesis and up-scaling of nanoparticles for molecular imaging (NanoPET and Micromod), and regulatory affairs (TOPASS) and MRB a research organization specialized in imaging technologies.
The IDEA project offers the possibility to develop and establish new therapeutic concepts of regenerative medicine that have the potential to overcome the drawbacks and limitations of current cure of cardiovascular, musculoskeletal, neuronal and other diseases and thus having the potential to improve the health of European citizens. In addition, the IDEA project will substantially increase the competitiveness boosting the innovative capacity of European health-related industries. The results of IDEA will take regenerative medicine to the next level of testing in clinical studies.

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Life Sciences
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