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

Critical Limb Ischemia (CLI) Clinical Trial

Official title: 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 Not yet recruiting

Clinical Trial 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).

Clinical Trial 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) ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Limb Ischemia (CLI)
• Ischemia

• NCT number: NCT02538978
• Study type: Interventional
• Source: Cesca Therapeutics, Inc.
• Contact: Kenneth Harris
• Phone: 510-844-7000
• Email: kharris@cescatherapeutics.com
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 2017
• Completion date: March 2019