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Using Mesenchymal Stem Cells to Fill Bone Void Defects in Patients With Benign Bone Lesions

NCT ID: NCT00851162

Last Updated: 2012-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-03-31

Brief Summary

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

Detailed Description

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Orthobiologics have recently become a mainstay in treating bony defects whether related to trauma, tumor, or other various reconstructive entities.1 Historically, benign bone growths that were excised, would be filled with either cement, autograft bone, or allograft substances. More recently, other substances have been utilized. These substances carry any or all osteoinductive, osteoconductive, or osteogenic properties. Various materials have been used to fill bony voids specifically related to benign bone growths. Trinity™ by Blackstone Medical inc. is an allograft substance that has recently began utilization. The difference in Trinity compared to various other allografts is that it utilizes mesenchymal stem cells (MSC) along with an allograft carrier to incorporate and induce bone formation. Previously, in order for stem cells to be included in grafting, it would require bone marrow aspiration and the morbidity that is associated with iliac crest bone grafting.

Trinity MSC's are pre-immunodepleted and therefore, do not stimulate local T-cell proliferation but instead are activated to act as osteoblasts and stimulate bone formation. This local response, could accelerate healing, earlier weight-bearing, healing, and filing of bone voids in patients that have had excision of bony masses. In previous animal models, the use of MSC's have been shown to increase bone healing in critical sized defects.

Trinity is currently approved for FDA use in bone defects specifically within the spine or trauma. It has not been shown to have any significant adverse events over standard bone substitute products. We hypothesize benign bone lesions that undergo curettage and filling with Trinity will heal faster than bone lesions filled with basic bone grafting.

Conditions

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Bone Neoplasms

Keywords

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Bone defect Benign bone lesions Stem cells

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Trinity

Trinity multipotent stem cells

Group Type EXPERIMENTAL

Trinity multipotent stem cells

Intervention Type BIOLOGICAL

Enough to fill voids which vary in size

Demineralized bone matrix

Demineralized bone matrix

Group Type ACTIVE_COMPARATOR

Demineralized bone matrix(DBM)

Intervention Type BIOLOGICAL

Enough DBM to fill a bone void defect

Interventions

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Trinity multipotent stem cells

Enough to fill voids which vary in size

Intervention Type BIOLOGICAL

Demineralized bone matrix(DBM)

Enough DBM to fill a bone void defect

Intervention Type BIOLOGICAL

Other Intervention Names

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Grafton

Eligibility Criteria

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Inclusion Criteria

* Ages \> 11 years
* Benign bone lesion

Exclusion Criteria

* Previous surgery
Minimum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Shervin Oskouei

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shervin Oskouei, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University Department of Orthopaedics

Locations

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Emory University

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00009762

Identifier Type: -

Identifier Source: org_study_id