NCT00616980

Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia

Injection of Autologous CD34-Positive Cells for Improved Symptomatic Relief and Ischemic Wound Healing in Subjects With Moderate or High-Risk Critical Limb Ischemia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Losordo, Douglas, M.D. · Individual
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of intramuscular injections of adult stem cells in patients with Critical Limb Ischemia (CLI).

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	CD34-positive cells
BIOLOGICAL	CD34-positive cells
BIOLOGICAL	Saline and 5% autologous plasma

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-04-01
• Completion: 2010-08-01
• First posted: 2008-02-15
• Last updated: 2011-07-25

Locations

12 sites across 1 country: United States