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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03746899
Study type Expanded Access
Source WideTrial, Inc.
Contact Heather Manna
Phone 415 691 4556
Email heather.manna@widetrial.com
Status Available
Phase

See also
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Active, not recruiting NCT03006770 - Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization Phase 3
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Not yet recruiting NCT02538978 - Critical Limb Ischemia Rapid Delivery by SurgWerks-CLI Kit and VXP System Phase 3
Completed NCT01408381 - Intra-arterial Infusion of Autologous Bone Marrow Mononuclear Cells in Non-diabetic Patients With Critical Limb Ischemia (CLI). Phase 2
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Active, not recruiting NCT04227899 - LIFE-BTK Randomized Controlled Trial N/A
Terminated NCT03111238 - The Efficacy and Safety of REX-001 to Treat Ischemic Rest Pain in Subjects With CLI Rutherford Category 4 and DM Phase 3
Terminated NCT03174522 - The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM Phase 3
Completed NCT01386216 - Safety Study of Bone Marrow Cell Concentrate Prepared Using the Magellan System to Treat Critical Limb Ischemia (CLI) Phase 1
Available NCT03886506 - Expanded Access Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization