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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

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.

Call for proposal

H2020-SC1-2016-RTD
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Coordinator

CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Address
Chariteplatz 1
10117 Berlin
Germany
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 2 199 250

Participants (8)

PARACELSUS MEDIZINISCHE PRIVATUNIVERSITAT SALZBURG - PRIVATSTIFTUNG
Austria
EU contribution
€ 687 250
Address
Strubergasse 21
5020 Salzburg
Activity type
Higher or Secondary Education Establishments
ASKLEPIOS KLINIKEN HAMBURG GMBH
Germany
EU contribution
€ 100 075
Address
Rubenkamp 226
22307 Hamburg
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
TECHNISCHE UNIVERSITAET DRESDEN
Germany
EU contribution
€ 65 018,75
Address
Helmholtzstrasse 10
01069 Dresden
Activity type
Higher or Secondary Education Establishments
PLURISTEM LTD
Israel
EU contribution
€ 3 076 750
Address
Matam Industrial Park Bldg 20
31905 Haifa
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ICON CLINICAL RESEARCH LIMITED
Ireland
EU contribution
€ 625 000
Address
South County Business Park Leopardstown
18 Dublin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Genome Identification Diagnostics GmbH
Germany
EU contribution
€ 161 000
Address
Ebinger Str. 4
72479 Strassberg
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ALTA RICERCA E SVILUPPO IN BIOTECNOLOGIE SRLU

Participation ended

Italy
EU contribution
€ 224 000
Address
Via Fiorentina 151
53100 Siena
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
INNOVATION ACTA S.R.L.
Italy
EU contribution
€ 67 875
Address
Via D.a. Azuni, 9
00196 Roma
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)