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

Human Stem Cell Institute, Russia

Status and phase: Completed; Phase 4

Conditions: Lower Limb Ischemia

Treatments: Drug: Neovasculgen®

Study type: Interventional

Funder types: Other

Identifiers

NCT02369809

NVG-03

Details and patient eligibility

About

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®.

Full description

This is an open, controlled, prospective, comparative, multicentre study design. All patients received standard conservative therapy for chronic limb ischemia without cilostazol and prostaglandins and without surgical or endovascular vessel reconstruction. Surgical and endovascular vessel reconstruction was unsuitable for all of the patients

Enrollment: 210 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Neovasculgen®

Experimental group

Description:

Single group prospective treatment

Treatment:

Drug: Neovasculgen®

standard care

Active Comparator group

Treatment:

Drug: Neovasculgen®