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Feasibility Study of Aastrom Tissue Repair Cells to Treat Non-Union Fractures.

NCT00424567 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-05-11

No results posted yet for this study

Summary

The purpose of this multi-center study is to obtain clinical data to substantiate that Aastrom TRC autologous bone marrow cells will regenerate bone in patients with established (appendicular skeletal) non union fractures, when used with one of the commonly employed commercially available allograft chip matrices.

Conditions

  • Fracture, Ununited
  • Pseudarthrosis

Interventions

PROCEDURE

Fracture surgery

DRUG

Cultured Bone Marrow Tissue

Sponsors & Collaborators

  • Vericel Corporation

    lead INDUSTRY

Principal Investigators

  • Matthew Jimenez, MD · Illinosis Bone and Joint Institute

  • James Goulet, MD · University of Michigan

  • Thomas Lyon, MD · Lutheran Medical Center

  • Nowinski, MD · William Beaumont Hospitals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Completion
2007-06-30

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 NCT00424567 on ClinicalTrials.gov