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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-20

Study Completion Date

2020-01-10

Brief Summary

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

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Detailed Description

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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.

Conditions

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Critical Limb Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects who received AMG0001

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

Subjects from Study AG-CLI-0206 who received AMG0001

Intervention Type BIOLOGICAL

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

Interventions

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Subjects from Study AG-CLI-0206 who received AMG0001

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No