NCT02538978

Critical Limb Ischemia Rapid Delivery by SurgWerks-CLI Kit and VXP System

Safety and Effectiveness of the SurgWerksTM-CLI Kit and VXPTM System for the Rapid Intra-operative Aspiration, Preparation and Intramuscular Injection of Concentrated Autologous Bone Marrow Cells Into the Ischemic Index Limb of Rutherford Category 5 Non-Reconstructable Critical Limb Ischemia Patients

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Cesca Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, double-blinded, randomized, placebo-controlled, multi-center, pivotal clinical study in which subjects are evaluated for prevention of major limb amputation in the treatment of non-reconstructable Rutherford Category 5 critical limb ischemia (CLI). Subjects will be randomized in 3:1 ratio (device treatment: placebo-control).

Detailed description

Device arm subjects will receive an intra-operative point of care aspiration, preparation and intramuscular injection of autologous bone marrow cell concentrate (aBMC) into the afflicted lower index limb. Bone marrow will be collected bilaterally from the patient's iliac crests using the SurgWerks-CLI Kit aspiration trocar under local anesthesia with mild to moderate sedation or general anesthesia, processed through the VXP System device to yield a rich cell and plasma concentrate ("aBMC"). Additionally, 10 mL of autologous peripheral blood will be aspirated for the placebo preparation. The Treatment Arm will receive the aBMC, which will be intramuscularly injected at multiple mapped sites/angiosomes into the ischemic index limb using the SurgWerks-CLI Kit supplied Therapeutic Infusion Needles and standard hypodermic needles. The procedure will be performed in a surgical suite and will take approximately 1.5-2.0 hours to complete. The subjects will be observed for 24 hours following the procedure for observation and control as necessary of post-operative pain, bleeding, and infection. Placebo Arm subjects will undergo an intra-operative point of care aspiration and preparation of bone marrow via the investigational device exactly as the Treatment Arm. However, instead of receiving the dosing with the aBMC device output, they will receive an intramuscular injection of diluted autologous peripheral blood into the afflicted lower index limb. At pre-specified follow-up intervals, all subjects in each arm will be evaluated for: * Major limb amputation free survival * Time to Treatment Failure (TTF) * Wound healing: Quantitative evaluation of wound(s) * Quality of life assessment (VascuQoL and SF-36) * Skin Perfusion Pressure (SPP) - Quantitative evaluation of blood flow * Rest pain assessment * Brachial Index (ABI)

Conditions

• Critical Limb Ischemia (CLI)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-12-01
• Completion: 2019-03-01
• First posted: 2015-09-02
• Last updated: 2016-07-28