Study to assess the long term safety of subjects who have been treated with AMG0001

Phase 1

Conditions: Critical limb ischemia
MedDRA version: 19.0Level: LLTClassification code 10058069Term: Critical limb ischemiaSystem Organ Class: 100000004866
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2016-003491-41-HU

Lead Sponsor: AnGes Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 23

Inclusion Criteria

1. Subjects who have been treated with AMG0001 in the AG-CLI-0206 study.
2. Subjects who have provided consent for the long term follow-up study either directly or through a legally authorized representative.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects who were not enrolled in the AG-CLI-0206 study.
2. Subjects who enrolled in AG-CLI-0206 and who were not treated with AMG0001.
3. Subjects who have not provided consent for the long term follow-up study either directly or through a legally authorized representative.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to assess the long term safety of subjects from the AG-CLI-0206 study who have been treated with AMG0001;Secondary Objective: ;Primary end point(s): The primary objective of this study is to fulfill the long term safety reporting requirements from health authorities of clinical studies that use a gene therapy investigational product.;Timepoint(s) of evaluation of this end point: Subjects complete questionnaire every 6 months for a total follow-up period of approximately 3 yrs.<br>

Secondary Outcome Measures