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Safety Study of Bone Marrow Cell Concentrate Prepared Using the Magellan System to Treat Critical Limb Ischemia (CLI)

NCT01386216 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-01-24

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety of administration of marrow-derived autologous hematopoietic stem cells (HSC) concentrate and platelet-rich plasma (PRP) gel for the treatment of Critical Limb Ischemia (CLI).

Conditions

  • Critical Limb Ischemia (CLI)
  • Peripheral Vascular Disease (PVD)

Interventions

DEVICE

Magellan®

Autologous Bone Marrow Cell Concentrate Prepared Using the Magellan System to be injected into the ischemic muscle tissue at 0.5 cc/injection for a total of 12-20 cc.

Sponsors & Collaborators

  • Arteriocyte, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Go, MD · Ohio State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2016-04-30
Completion
2016-12-31

Countries

  • United States

Study Locations

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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 NCT01386216 on ClinicalTrials.gov