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

Phase 2

Withdrawn

• Conditions: Bone Neoplasms
• Interventions: Biological: Demineralized bone matrix(DBM); Biological: Trinity multipotent stem cells

• Registration Number: NCT00851162
• Lead Sponsor: Emory University

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-02-24
• Study First Submitted QC: 2009-02-24
• Study First Posted: 2009-02-25
• Study Start: 2009-03
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-27
• Last Update Posted: 2012-11-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Ages > 11 years
• Benign bone lesion

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Exclusion Criteria

• Previous surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Demineralized bone matrix	Demineralized bone matrix(DBM)	Demineralized bone matrix
Trinity	Trinity multipotent stem cells	Trinity multipotent stem cells

Primary Outcome Measures

Name	Time	Method
Time to fill bony defect	Two to 52 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse reaction from bone graft	Immediately after surgery to one year

Trial Locations

Locations (1)

Emory University; 🇺🇸 Atlanta, Georgia, United States