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

NCT02538978 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2016-07-28

No results posted yet for this study

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).

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.

Sponsors & Collaborators

  • Cesca Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Dalip Sethi, PhD · Cesca Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-12-31
Completion
2019-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02538978 on ClinicalTrials.gov