NCT02538978 - Critical Limb Ischemia Rapid Delivery by SurgWerks-CLI Kit and VXP System | Biotech Hunter

Enrollment

224

Participants

Timeline

Start Date

January 31, 2017

Primary Completion Date

December 31, 2018

Study Completion Date

March 31, 2019

Conditions

Critical Limb Ischemia (CLI)

Interventions

BIOLOGICAL

Autologous Bone Marrow Concentrate (aBMC)

"Aspirated bone marrow will be processed by centrifugation, separating out a concentrate (aBMC) comprising primarily white blood cells and platelets. These cells will be injected i.m. to loci determined by the operating physician using imaging and vascular flow criteria.~Device: SurgWerks-CLI Kit~Device: VXP System"

BIOLOGICAL

Placebo Control (diluted autologous peripheral blood)

Diluted peripheral blood prepared in a blinded fashion to resemble bone marrow will be injected intramuscularly per the same procedure used for the Experimental Device Arm.