Overview

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)