A multicenter phase III study using HLA-unmatched allogeneic placenta-derived stromal cells (PLX-PAD) for the treatment of severe critical limb ischemia accompanied by mechanistic studies
WP1 Manufacturing of PLX-PAD product(s)
WP1 Manufacturing of PLX-PAD product(s)
The Pluristem team, coordinated by R Ofir, E Lukasiewicz-Hagai, will bring in its first-in-class IP-protected manufacturing process for expansion of PLX-PAD cells, including the surrounding QC expertise.
PLX-PAD cells are manufactured, packaged and labelled by Pluristem Ltd. in GMP-compliant facilities located in Haifa, Israel. The PLX-PAD cell expansion manufacturing process is described in the figure below
WP2 Targets the analysis of the molecular and functional signature of PLX-PAD product
WP2 Targets the analysis of the molecular and functional signature of PLX-PAD product
WP2 targets the analysis of the molecular and functional signature of PLX-PAD product, including in depth analysis of batch-to-batch and donor-to-donor variability.
PDuring the long-lasting collaboration with Pluristem, BCRT has implemented several core technologies applied for cell characterisation, including PLX cells. The following well established platforms will be applied in PACE:
WP3 Randomized, double-blind, multicenter, placebo-controlled, parallel-group phase III
WP3 Randomized, double-blind, multicenter, placebo-controlled, parallel-group phase III
The WP3 is a randomized, double-blind, multicenter, placebo-controlled, parallel-group phase III study to evaluate the efficacy, tolerability and safety of intramuscular injections of PLX-PAD for the treatment of subjects with critical limb ischemia (CLI) with minor tissue loss who are unsuitable for revascularization.
Protocol Number of the study: PLX-CLI-03
Investigational Treatment: PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells
The clinical study is sponsored by Pluristem. The CRO involved in the clinical trial is ICON, a global player in the field and well experienced in monitoring international multicentre studies under EMA and FDA rules. ICON has previously conducted a multinational Phase III in 800 CLI patients..
Very importantly, the clinical study is supported by excellent clinicians, who are internationally well recognized experts in clinical research and medical management of cardiovascular and diabetic diseases and have participated as PI´s in several clinical studies in the past.
WP4 Study of biomarker for monitoring the therapy
WP4 Study of biomarker for monitoring the therapy
WP4 focuses on the study of biomarker for monitoring the therapy. The panel was designed by the Pluristem team in collaboration with Charité, P1 (P Reinke, HD Volk, U Landmesser) and the main clinical investigators of the study (S Nikol, N Weiss). The panel goes far beyond typical standard laboratory markers and addresses the following questions:
WP5 Exploratory tests in mechanistic side-studies on subgroups of patients
WP5 Exploratory tests in mechanistic side-studies on subgroups of patients
WP5 utilises highly specialised, exploratory tests in mechanistic side-studies on subgroups of patients:
WP6 Project management and coordination
WP6 Project management and coordination
We ensure efficient operational management including that of administrative, financial and legal issues The goal of this WP is to establish and guarantee full synergy, motivation, integration and effective interactions among PACE participants.
WP7 Communication, dissemination, training and exploitation
WP7 Communication, dissemination, training and exploitation
WP7 Communication, dissemination, training and exploitation. The focus is to set up of the proper tools and activities of communicating the project results and new achievement to the general public and patients, clinical/scientific community. The main dissemination activities are:
Training activities include mainly the following:
Particular attention is also devoted to the exploitation of the project results, that will be transferred to and absorbed by the project industrial stakeholders Pluristem and GenID.
Marketing and business development will mostly be managed by Pluristem, with support from the clinical and business development departments of Charité.
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