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

Phase 1

• Conditions: Critical limb ischemia; MedDRA version: 20.0Level: LLTClassification code 10058069Term: Critical limb ischemiaSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-003491-41-FR
• Lead Sponsor: AnGes Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-16
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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