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Clinical Trials/NCT00851162
NCT00851162
Withdrawn
Phase 2

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

Emory University1 site in 1 countryMarch 2009
ConditionsBone Neoplasms

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Bone Neoplasms
Sponsor
Emory University
Locations
1
Primary Endpoint
Time to fill bony defect
Status
Withdrawn
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
March 2010
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shervin Oskouei

MD

Emory University

Eligibility Criteria

Inclusion Criteria

  • Ages \> 11 years
  • Benign bone lesion

Exclusion Criteria

  • Previous surgery

Outcomes

Primary Outcomes

Time to fill bony defect

Time Frame: Two to 52 weeks

Secondary Outcomes

  • Adverse reaction from bone graft(Immediately after surgery to one year)

Study Sites (1)

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