NCT02941419

Treatment of PAD by Platelet Lysate for Therapeutic Angiogenesis

Safety and Efficacy of Platelet Lysate for Therapeutic Angiogenesis in Patients With Peripheral Arterial Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Jordan · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Induction of autologous angiogenesis in patients with critical limb ischemia using platelet lysate.

Detailed description

Ten male and female patients diagnosed with Peripheral artery disease (PAD), will be recruited. This diagnosis will be based on medical history, physical examinations, laboratory tests, and specific diagnostic tests. Patients qualified for this study, are patients with distal extremity ischemia indicated by claudication and rest pain present for a minimum of 4 weeks without evidence of improvement in response to conventional drug therapy; showed angiographic evidence of PAD in the affected limb; and were not candidates for surgical revascularization. Platelet lysate will be injected intramuscularly at different sites of the gastrocnemius muscle. The purpose of this study is to evaluate the safety and efficacy of platelet lysate injections into ischematic limbs of patients with PAD.

Conditions

• Critical Limb Ischemia

Interventions

Type	Name	Description
BIOLOGICAL	Platelet lysate	Autologous intramuscular platelet lysate injection for patients with peripheral arterial disease

Timeline

• Start date: 2013-03-05
• Primary completion: 2016-09-15
• Completion: 2017-02-09
• First posted: 2016-10-21
• Last updated: 2017-05-04