The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM
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|ClinicalTrials.gov Identifier: NCT03174522|
Recruitment Status : Recruiting
First Posted : June 2, 2017
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease (PAD) Diabetes Mellitus (DM) Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Cardiovascular Disease Critical Limb Ischemia (CLI)||Drug: REX-001 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Efficacy and Safety of Intra-arterial Administration of REX-001 to Treat Ischemic Ulcers in Subjects With Critical Limb Ischemia (CLI) Rutherford Category 5 and Diabetes Mellitus: A Pivotal, Placebo-controlled, Double-blind, Parallel-group, Adaptive Trial|
|Actual Study Start Date :||April 25, 2017|
|Estimated Primary Completion Date :||October 31, 2020|
|Estimated Study Completion Date :||October 31, 2021|
REX-001 is a cell suspension of autologous bone marrow mononuclear cells (BM-MNCs) composed of several mature cell types.
REX-001 is administered through an intra-arterial catheter.
Placebo Comparator: Placebo
The final formulation of the placebo will be a diluted suspension of red blood cells.
Placebo is administered through an intra-arterial catheter.
- Complete healing of all ischemic ulcers on the index leg. [ Time Frame: The primary endpoint for this trial will be assessed at 12 months. ]Change in Rutherford classification from CLI Category 5 to Category 4 or lower 12 months. after administration of Rexmyelocel-T or placebo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174522
|Contact: Edwin Wagena, PhD||+31 6 email@example.com|
|Contact: Karen Reitsma, PhDfirstname.lastname@example.org|
|First site: Hospital Reina Sofía de Córdoba||Recruiting|
|Cordoba, Córdoba, Spain, 14004|
|Contact: Jose García-Revillo, MD|
|Contact: Antonio Chacón, MD|
|Study Director:||Edwin Wagena, PhD||Rexgenero Limited|