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

Clinical Trial Details

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

View Details

See also
Status	Clinical Trial	Phase
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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
Completed	`NCT00987363` - Intraarterial Infusion of Autologous Bone Marrow in Diabetic Patients With Chronic Ischemia of Lower Limbs (CLI) no Revascularization	Phase 1/Phase 2
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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Recruiting	`NCT04849325` - IBS Titan vs. PTA in Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease	N/A
Completed	`NCT01257776` - Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients	Phase 1/Phase 2
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	`NCT03746899` - Expanded Access for Treatment Use of PLX-PAD in Critical Limb Ischemia (CLI)
Available	`NCT03886506` - Expanded Access Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.