NCT01584986

Autologous Angiogenic Cell Precursors (ACPs) for the Treatment of Peripheral Artery Disease

Autologous Stem Cell Therapy for the Treatment of Patients With Peripheral Artery Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Salus Ltd. · Industry
• Sex: —
• Age: —
• Healthy volunteers: Not accepted

Summary

Regeneration of the occluded peripheral arteries by autologous stem cell therapy is an emerging treatment modality for no-option patients with peripheral artery disease (PAD). The purpose of this study was to assess safety and efficacy of ex vivo expanded, peripheral blood-derived, autologous angiogenic cell precursors (ACPs) in no-option PAD patients.

Detailed description

Late-stage no-option PAD patients with a high risk of amputation of the affected limb were enrolled and randomized into treated and control groups. In the 10 ACP treated patients the stem cells were injected into the ischemic gastrocnemius muscle. The 10 control patients were treated with the conventional therapy. Physical examination, a treadmill walking test were performed, ankle brachial index (ABI), transcutaneous oxygen pressure (TcO2) were measured at baseline, 1 and 3 months later. Digital substraction angiography and SF-36 quality-of-life (QoL) questionnaire were also performed at baseline and 3 months later.

Conditions

• Critical Limb Ischemia

Interventions

Type	Name	Description
BIOLOGICAL	ACP injections	Peripheral blood-derived, ex vivo expanded autologous angiogenic cell precursors (ACPs)

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-04-01
• Completion: 2009-07-01
• First posted: 2012-04-25
• Last updated: 2012-04-25

Locations

2 sites across 1 country: Hungary