Clinical study

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: PLX-CLI-03
Investigational Treatment: PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells.

STUDY OBJECTIVES: The objective of the study is to evaluate the efficacy, tolerability and safety of local intramuscular (IM) injections of PLX-PAD in CLI subjects unsuitable for revascularization.

POPULATION: The study will be conducted in 246 subjects diagnosed with CLI with minor tissue loss (Rutherford Category 5) who are unsuitable for revascularization.

schema 1

Survival analysis with variable follow up to enhance Power
Study end: 12 months after the actual/planned 1st treatment visit of the last randomized subject, or 36 months after actual/planned 1st treatment visit of the first randomized subject, the later of the two.
Each subject will be followed-up until the End of Study or until completing 36 months of follow-up, the earlier of the two (hence, range between 12 to 36 months).

schema 2