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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

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

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.
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Coordinator

CHARITE - UNIVERSITAETSMEDIZIN BERLIN

Address

Chariteplatz 1
10117 Berlin

Germany

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 2 336 500

Participants (7)

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PARACELSUS MEDIZINISCHE PRIVATUNIVERSITAT SALZBURG - PRIVATSTIFTUNG

Austria

EU Contribution

€ 687 250

ASKLEPIOS KLINIKEN HAMBURG GMBH

Germany

EU Contribution

€ 187 750

TECHNISCHE UNIVERSITAET DRESDEN

Germany

EU Contribution

€ 219 000

PLURISTEM LTD

Israel

EU Contribution

€ 3 076 750

ICON CLINICAL RESEARCH LIMITED

Ireland

EU Contribution

€ 625 000

Genome Identification Diagnostics GmbH

Germany

EU Contribution

€ 188 465

ALTA RICERCA E SVILUPPO IN BIOTECNOLOGIE SRLU

Italy

EU Contribution

€ 275 000

Project information

Grant agreement ID: 733006

Status

Ongoing project

  • Start date

    1 January 2017

  • End date

    31 December 2020

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 7 595 715

  • EU contribution

    € 7 595 715

Coordinated by:

CHARITE - UNIVERSITAETSMEDIZIN BERLIN

Germany