NCT00919958

Safety of Intramuscular Injection of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia

Phase I Study of Intramuscular (IM) Injection of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia. PLX-PAD Are Mesenchymal-like Stromal Cells Derived From a Full Term Placenta. These Placental Adherent Stromal Cells (ASCs) Are Expanded in the Company's Proprietary PluriXTM 3D Bioreactor System. PLX Cells Are Immune Privileged and Possess Immunomodulatory Properties.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Pluristem Ltd. · Industry
• Sex: All
• Age: 40 Years – 81 Years
• Healthy volunteers: Not accepted

Summary

The The purpose of this study is to determine the safety of PLX-PAD single dose, Intra-muscular injection for the treatment of CLI patients.

Detailed description

PLX-PAD are mesenchymal-like stromal cells derived from a full term placenta, termed PLX-PAD, and intended for the treatment of Critical Limb Ischemia

Conditions

• Peripheral Artery Disease
• Peripheral Vascular Disease
• Critical Limb Ischemia

Interventions

Type	Name	Description
BIOLOGICAL	PLX-PAD IM injection	Single treatment; multiple injections

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2009-06-12
• Last updated: 2012-06-19

Locations

1 site across 1 country: Germany