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Expanded Access for Treatment Use of PLX-PAD in Critical Limb Ischemia (CLI)

NCT03746899 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2019-01-08

No results posted yet for this study

Summary

This is an Expanded Access program (EAP), sponsored by WideTrial for the treatment of critical limb ischemia (CLI).

Widetrial, an Expanded Access specialist, has arranged to supply participating sites with PLX-PAD for CLI patients who cannot participate in the ongoing research trial and who seek exploratory treatment options. This program includes FDA-authorized cost recovery, meaning payment is required to cover a portion of the costs of delivering product and complying with regulatory obligations.

Conditions

  • Critical Limb Ischemia (CLI)

Interventions

BIOLOGICAL

PLX-PAD

PLX-PAD cell therapy to be administered via 30 IM injections (0.5 mL each) to the index leg leg per treatment, in each of two treatments, 8 weeks apart

Sponsors & Collaborators

  • WideTrial, Inc.

    lead INDUSTRY

Eligibility

Min Age
45 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03746899 on ClinicalTrials.gov