Organization

The PACE consortium is coordinated by the Charité Berlin. The project coordinator is Prof. HD Volk, clinical immunologist, head of the Berlin-Brandenburg Centre for Regenerative Therapies (BCRT), an internationally visible translational medicine center. PACE brings together partners from seven institutions from four countries with excellent expertise in the fields of cell therapy and CLI studies.

schema


The specific objectives of PACE will be achieved in seven work packages


WP1 Manufacturing of PLX-PAD product(s)

Task 1.1 Manufacturing (leaded by Pluristem)

WP2 Molecular and functional signature of the PLX-PAD cell product
Task 2.1 Flowcytometric profiling of PLX-PAD batches (conducted by Charité and Pluristem)
Task 2.2 Mass-cytometric profiling of PLX-PAD batches (conducted by Charité and Pluristem)
Task 2.3 Modulation of endothelial (EC) functionality in vitro and in vivo (conducted by PMU, Charité and Pluristem)
Task 2.4 Immunomodulation in vitro and in vivo (conducted by Charité, PMU and Pluristem)
Task 2.5 Molecular profiling of PLX-PAD batches (conducted by Charité, PMU and Pluristem)
Task 2.6 Establishment and PoC of a novel in vitro test systems for ATMPs on 3D-multiorgan-chip (human-on-the-chip) (conducted by Charité and Pluristem)

WP3 Clinical phase III study PACE
Task 3.1 Finalisation of all documents and contracting of all clinical centres (conducted by ICON and Pluristem, with the collaboration of the clinical centres Charité, PMU, Asklepios and UGC Dresden)
Task 3. First-patient-in (conducted by ICON and Pluristem, with the clinical centres Charité, PMU, Asklepios and UGC Dresden) 
Task 3.3  Last patient-in (conducted by ICON and Pluristem, with the clinical centres Charité, PMU, Asklepios and UGC Dresden & further clinical centres)
Task 3.4 1yr- Follow-up of all patients (conducted by ICON and Pluristem, with the clinical centres Charité, PMU, Asklepios and UGC Dresden & further clinical centres)
Task 3.5  Monitoring, QC of data, Data analysis (conducted by ICON and Pluristem)
Task 3.6: To establish a data safety monitoring board (DSMB) and a safety advisory board (SAB) (conducted by ICON, Pluristem and Charité)

WP4 Biomarkers in the follow-up of the study patients
Task 4.1 Soluble ligand response (conducted by Charité)
Task 4.2 Humoral alloresponse (conducted by Charité)
Task 4.3 (months 1-48): Impact on RNA profiles (mRNAs, miRNAs) by applying NGS (RNAseq) and bioinformatic analyses (conducted by Charité, PMU and UGC Dresden)

WP5 Exploratory molecular, immunological, and functional biomarker and mechanistical side studies to reveal better understanding of mode-of-action
Task 5.1 Impact on T2D (conducted by Charité and UGC Dresden)
Task 5.2 Cellular Alloreactivity (conducted by Charité and GenID)
Task 5.3 Circulating endothelial cells (CEC) and endothelial progenitor cells (EPC) (conducted by Charité and PMU)
Task 5.4 Single CEC/EPC profiling (conducted by Charité)
Task 5.5 Proangiogenic factors (conducted by PMU)

WP6 Project Management and Coordination
Task 6.1 Overall project management (conducted by Charité and ALTA with the support and the advice of the external management bodies of PACE)
Task 6.2 Financial and administrative management (conducted by Charité and ALTA)
Task 6.3 Risk management (conducted by Charité with support of Pluristem, ALTA and the External Boards)
Task 6.4 IPR Management (conducted by Charité, Pluristem, GenID and ICON)

WP7 Communication, dissemination, training and exploitation
Task 7.1 Dissemination and raising awareness (conducted by all the partners)
Task 7.2 Development, maintenance and improvements of the project web site (conducted by Charité, Pluristem and ALTA)
Task 7.3 Training (conducted by all the partners)
Task 7.4 Exploitation of project results (conducted by all the partners)
Task 7.5 Final workshop (conducted by all the partners)

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Work packages