NCT00851162

Brief Summary

The purpose of this study is to determine whether using mesenchymal stem cells will heal benign bone lesion defects faster than demineralized bone matrix

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

November 28, 2012

Status Verified

November 1, 2012

Enrollment Period

1 year

First QC Date

February 24, 2009

Last Update Submit

November 27, 2012

Conditions

Bone Neoplasms

Keywords

Bone defectBenign bone lesionsStem cells

Outcome Measures

Primary Outcomes (1)

  • Time to fill bony defect

    Two to 52 weeks

Secondary Outcomes (1)

  • Adverse reaction from bone graft

    Immediately after surgery to one year

Study Arms (2)

Trinity

EXPERIMENTAL

Trinity multipotent stem cells

Biological: Trinity multipotent stem cells

Demineralized bone matrix

ACTIVE COMPARATOR

Demineralized bone matrix

Biological: Demineralized bone matrix(DBM)

Interventions

Trinity multipotent stem cellsBIOLOGICAL

Enough to fill voids which vary in size

Trinity
Demineralized bone matrix(DBM)BIOLOGICAL

Enough DBM to fill a bone void defect

Also known as: Grafton
Demineralized bone matrix

Eligibility Criteria

Age11 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Ages \> 11 years
  • Benign bone lesion

You may not qualify if:

  • Previous surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University

Atlanta, Georgia, 30306, United States

Location

MeSH Terms

Conditions

Bone Neoplasms

Interventions

Grafton demineralized bone matrix gel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Study Officials

  • Shervin Oskouei, MD

    Emory University Department of Orthopaedics

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 24, 2009

First Posted

February 25, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

November 28, 2012

Record last verified: 2012-11

Locations

US(1)