Scimitar Equity Blog

PSTI data from clinical trials show their placenta-derived cell therapy, PLX-PAD, is safe and improves quality of life as well as other efficacy measurements in patients with Critical Limb Ischemia (CLI), the end-stage of Peripheral Artery Disease (PAD).

The 3 month follow-up data involved 21 patients afflicted with CLI in two open-label, dose-escalation, Phase I clinical trials conducted at Duke University Medical Center, Stanford University Medical Center, the Center for Therapeutic Angiogenesis in Birmingham, Alabama and St. Franziskus Hospital, supported by the Charité – University Medicine Berlin.

• The results of these clinical trials have enabled Pluristem to select the target treatment dose of PLX-PAD for additional studies focused on the cell therapy’s efficacy,
• PSTI has communicated with both the FDA and European Medicines Agency (EMA) concerning the design of an optimal multinational study that could support an approval for marketing PLX-PAD for the treatment of CLI.

The 2 Phase I studies were designed to evaluate the safety of PLX-PAD cells and included accessing the patient’s immunological profile before and after the local administration of PLX-PAD.

• In addition, efficacy parameters were assessed and 5 different doses of PLX-PAD were evaluated,
• These studies were performed in parallel in the EU and USA and represent the first time that PSTI’s PLX-PAD cells were administered to humans,
•  PLX-PAD cells are derived from human placenta, a non-controversial, non-embryonic, adult stem cell source.

Results included the findings that PLX-PAD cells can be administered safely as an “off-the-shelf” product without a need for matching between donor and patient.

• Additionally, efficacy was demonstrated across all doses with a statistically significant improvement noted in the pain score and quality of life,
• The intermediate dose also showed a statistically significant improvement in the Ankle Brachial Index (ABI), a measure of blood flow.