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PACE SIGNED

A multicenter phase IIb study using HLA-unmatched allogeneic placenta-derived stromal cells (PLX-PAD) for the treatment of severe critical limb ischemia accompanied by mechanistic studies

Total Cost €

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EC-Contrib. €

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Partnership

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 PACE project word cloud

Explore the words cloud of the PACE project. It provides you a very rough idea of what is the project "PACE" about.

cell    adaptive    risk    intramuscular    patient    female    aged    experts    trial    manufacturing    markers    force    ratio    allogeneic    molecular    male    patients    death    cardiovascular    prevalence    disease    despite    option    group    scalable    mechanistic    free    agency    pad    medicinal    injections    rising    world    off    designing    amputation    limb    safety    placenta    medical    population    pace    70    care    efficacy    double    clinical    grade    stromal    multiple    multicentre    ema    biomarker    endpoints    survival    therapy    shelf    lt    placebo    social    action    suffering    poor    improvements    incidence    plx    exploring    medicine    treatment    3d    accepted    characterizing    stratification    tolerability    response       critical    therapeutic    parallel    60    worldwide    blind    atmps    trials    transform    signature    revascularization    approved    mechanisms    pilot    performing    knee    biomarkers    below    unsuitable    expertise    limited    cli    mortality    outcome    options    randomized    hla    functional    unmatched    preclinical    ischemia       continue   

Project "PACE" data sheet

The following table provides information about the project.

Coordinator
CHARITE - UNIVERSITAETSMEDIZIN BERLIN 

Organization address
address: Chariteplatz 1
city: BERLIN
postcode: 10117
website: www.charite.de

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Germany [DE]
 Project website http://www.pace-h2020.eu/
 Total cost 7˙595˙715 €
 EC max contribution 7˙595˙715 € (100%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-SC1-2016-RTD
 Funding Scheme RIA
 Starting year 2017
 Duration (year-month-day) from 2017-01-01   to  2020-12-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    CHARITE - UNIVERSITAETSMEDIZIN BERLIN DE (BERLIN) coordinator 2˙336˙500.00
2    PLURISTEM LTD IL (HAIFA) participant 3˙076˙750.00
3    PARACELSUS MEDIZINISCHE PRIVATUNIVERSITAT SALZBURG - PRIVATSTIFTUNG AT (SALZBURG) participant 687˙250.00
4    ICON CLINICAL RESEARCH LIMITED IE (DUBLIN) participant 625˙000.00
5    ALTA RICERCA E SVILUPPO IN BIOTECNOLOGIE SRLU IT (SIENA) participant 275˙000.00
6    TECHNISCHE UNIVERSITAET DRESDEN DE (DRESDEN) participant 219˙000.00
7    Genome Identification Diagnostics GmbH DE (Strassberg) participant 188˙465.00
8    ASKLEPIOS KLINIKEN HAMBURG GMBH DE (HAMBURG) participant 187˙750.00

Map

 Project objective

PACE aims to transform the treatment of patients suffering from critical limb ischemia (CLI), a disease with high medical need, because of limited treatment options and poor outcome by applying a novel, off-the-shelf allogeneic placenta-derived stromal cell product (PLX-PAD). Despite improvements in medical care and revascularization, patients with CLI continue to have a high risk of major amputation (below the knee or higher) and cardiovascular death (1-year amputation-free survival <60%; 10-year mortality 70%). CLI has a strong social impact and its incidence is rising worldwide, including in Europe. The prevalence of CLI in the population aged 60–90 years is estimated as 1% (0.5–1.2%) with male to female ratio around 3:1. We will evaluate the efficacy, tolerability and safety of multiple intramuscular injections of HLA-unmatched allogeneic PLX-PAD for the treatment of CLI patients who are unsuitable for revascularization, in a randomized, double-blind, multicentre, placebo-controlled, parallel group phase II study. The European Medicine Agency (EMA) accepted PLX-PAD as pilot project for the new “Adaptive Pathways to Patients” to force timely access for patients to the new therapeutic option. The PACE consortium will go beyond the traditional clinical trial endpoints of safety and efficacy, by state-of-the-art characterizing molecular and functional signature of the PLX-PAD product(s), in depth investigating mechanisms-of-action of PLX-PAD therapy, and exploring biomarkers for understanding response/non-response in particular patients (stratification and therapy response markers). PACE partners are world-leading experts in scalable, clinical grade 3D-cell manufacturing approved by authorities, preclinical and clinical cell therapy, and biomarker analyses with well recognized expertise in designing and performing clinical trials, including those with Advanced Therapy Medicinal Products (ATMPs) integrated with in-patient biomarker and mechanistic side-studies.

 Deliverables

List of deliverables.
Publications and material for communication (flyers, press release, videos, seminars, publications) third yesr Websites, patent fillings, videos etc. 2020-04-08 14:23:15
Project visual identity Demonstrators, pilots, prototypes 2020-04-08 14:23:14
Project web site Other 2020-04-08 14:23:14
Publications and material for communication (flyers, press release, videos, seminars, publications) 1st year Websites, patent fillings, videos etc. 2020-04-08 14:23:14
Initial dissemination plan Documents, reports 2020-04-08 14:23:14

Take a look to the deliverables list in detail:  detailed list of PACE deliverables.

 Publications

year authors and title journal last update
List of publications.
2020 Guido Moll, Norman Drzeniek, Julian Kamhieh‐Milz, Sven Geissler, Petra Reinke
Editorial comment: variables affecting the presence of mesenchymal stromal cells in the peripheral blood and their relationship with apheresis product
published pages: , ISSN: 0007-1048, DOI: 10.1111/bjh.16389
British Journal of Haematology 2020-04-08
2019 Behnam Sadeghi, Gianluca Moretti, Fabian Arnberg, Erik Samén, Bita Kohein, Rusan Catar, Julian Kamhieh-Milz, Sven Geissler, Guido Moll, Staffan Holmin, Olle Ringdén
Preclinical Toxicity Evaluation of Clinical Grade Placenta-Derived Decidua Stromal Cells
published pages: , ISSN: 1664-3224, DOI: 10.3389/fimmu.2019.02685
Frontiers in Immunology 10 2020-04-08
2019 Anastazja Andrzejewska, Rusan Catar, Janosch Schoon, Taimoor Hasan Qazi, Frauke Andrea Sass, Dorit Jacobi, Antje Blankenstein, Simon Reinke, David Krüger, Mathias Streitz, Stephan Schlickeiser, Sarina Richter, Naima Souidi, Christien Beez, Julian Kamhieh-Milz, Ulrike Krüger, Tomasz Zemojtel, Karsten Jürchott, Dirk Strunk, Petra Reinke, Georg Duda, Guido Moll, Sven Geissler
Multi-Parameter Analysis of Biobanked Human Bone Marrow Stromal Cells Shows Little Influence for Donor Age and Mild Comorbidities on Phenotypic and Functional Properties
published pages: , ISSN: 1664-3224, DOI: 10.3389/fimmu.2019.02474
Frontiers in Immunology 10 2020-04-08
2020 Guido Moll *, Martin J. Hoogduijn and James A. Ankrum
Editorial: Safety, Efficacy and Mechanisms of Action of Mesenchymal Stem Cell Therapies
published pages: , ISSN: 1664-3224, DOI: 10.3389/fimmu.2020.00243
Frontiers in Immunology 2020-04-08
2017 Levent Akyüz*, Andreas Wilhelm, Florian Butke, Park Su-Jin, Anja Kuckuck, Hans-Dieter Volk, Gerald Grütz
Validation of novel multiplex technologies
published pages: , ISSN: 2424-9106, DOI:
Advances in precision medicine bi-annual 2020-04-08

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The information about "PACE" are provided by the European Opendata Portal: CORDIS opendata.

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