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Ixmyelocel-T Treatment of Patients With Osteonecrosis of the Femoral Head

NCT00505219 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2019-10-21

No results posted yet for this study

Summary

The purpose of this study is to determine if Ixmyelocel-T grafting with demineralized bone matrix bound in autologous plasma after core decompression surgery is superior to core decompression with demineralized bone matrix bound in autologous plasma in preventing progression of osteonecrosis to a more severe disease stage (Stage II to III or higher) from the time of surgery until 24 months later, in patients with University of Pennsylvania (UPenn) Stage IIB or C disease at diagnosis.

Conditions

  • Osteonecrosis

Interventions

BIOLOGICAL

Ixmyelocel-T

Core decompression of the femoral head to remove necrotic tissue with Ixmyelocel-T given to treatment arm only.

OTHER

Standard of Care Only

Core decompression of the femoral head to remove necrotic tissue

Sponsors & Collaborators

  • Vericel Corporation

    lead INDUSTRY

Principal Investigators

  • Marc Hungerford, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-09-30
Completion
2010-12-31

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 NCT00505219 on ClinicalTrials.gov