Non-Interventional Post Marketing Surveillance Study of Neovasculgen® in Patients With Chronic Lower Limb Ischemia

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Aim of the study is to gain more knowledge about efficacy and safety of Neovasculgen® in daily clinical practice and obtain information about the quality of life in patients treated with Neovasculgen®.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Human Stem Cell Institute, Russia

Criteria

Inclusion Criteria:

• Male or female person aged 40 or older

• Subject with diagnosed lower limb ischemia (Fontaine-Pokrovsky Stages IIa-III of chronic limb ischemia)

• Signed informed consent

Exclusion Criteria:

• Any disease that can, in the opinion of the treating physician, affect the outcome of the study

• Patients with addictive disorders or substance abuse

• Pregnancy or nursing

• All other exclusion criteria listed in the summary of product characteristics (SmPC)