A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia

AnGes USA, Inc.9 enrolled

Overview

Subjects from the AG-CLI-0206 phase 3 study that received AMG0001 will be eligible for the AG-CLI-0206-LTFU study

The study is designed to assess the long term safety of subjects who have been treated in the phase 3 study with AMG0001. A health questionnaire will be used to collect specific information from the subject every 6 months. Only those subjects that were randomized in the AG-CLI-0206 study and who received AMG0001 are eligible to participate in this long term follow-up study. Subjects that received placebo will not be eligible for participation in this study.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Critical Limb Ischemia

Interventions

Subjects from Study AG-CLI-0206 who received AMG0001BIOLOGICAL

Subjects from Study AG-CLI-0206 who received the study product AMG0001

Eligibility

Sex: ALLMin age: 40 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who have been treated with AMG0001 in the AG-CLI-0206 study. * Subjects who have provided consent for this long term follow-up study either directly or through a legally authorized representative. * Subjects who have provided a release of information to the sponsor. Exclusion Criteria: * Subjects who were not enrolled in the AGCLI-0206 study. * Subjects who enrolled in AG-CLI-0206 and who were not treated with AMG0001. * Subjects who have not provided consent to this long term follow-up study either directly or through a legally authorized representative. * Subjects who have not provided a release of information for the Sponsor to contact them directly via phone, email and/or mail.

Locations (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Outcomes

Primary Outcomes

Assess the long term safety of subjects from the AG-CLI-0206 study who have been treated with AMG0001

A health questionnaire will be used to collect specific information from the subject every 6 months

Time frame: 3 years from the date last subject randomized into AG-CLI-0206 study

Data from ClinicalTrials.gov

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