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

Primary Purpose

Bone Neoplasms

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Trinity multipotent stem cells
Demineralized bone matrix(DBM)
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Neoplasms focused on measuring Bone defect, Benign bone lesions, Stem cells

Eligibility Criteria

11 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages > 11 years
  • Benign bone lesion

Exclusion Criteria:

  • Previous surgery

Sites / Locations

  • Emory University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trinity

Demineralized bone matrix

Arm Description

Trinity multipotent stem cells

Demineralized bone matrix

Outcomes

Primary Outcome Measures

Time to fill bony defect

Secondary Outcome Measures

Adverse reaction from bone graft

Full Information

First Posted
February 24, 2009
Last Updated
November 27, 2012
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT00851162
Brief Title
Using Mesenchymal Stem Cells to Fill Bone Void Defects in Patients With Benign Bone Lesions
Official Title
Using Mesenchymal Stem Cells to Fill Bone Void Defects in Patients With Benign Bone Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Study was not continued due to lack of enrollment.
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
March 2010 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Neoplasms
Keywords
Bone defect, Benign bone lesions, Stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trinity
Arm Type
Experimental
Arm Description
Trinity multipotent stem cells
Arm Title
Demineralized bone matrix
Arm Type
Active Comparator
Arm Description
Demineralized bone matrix
Intervention Type
Biological
Intervention Name(s)
Trinity multipotent stem cells
Intervention Description
Enough to fill voids which vary in size
Intervention Type
Biological
Intervention Name(s)
Demineralized bone matrix(DBM)
Other Intervention Name(s)
Grafton
Intervention Description
Enough DBM to fill a bone void defect
Primary Outcome Measure Information:
Title
Time to fill bony defect
Time Frame
Two to 52 weeks
Secondary Outcome Measure Information:
Title
Adverse reaction from bone graft
Time Frame
Immediately after surgery to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages > 11 years Benign bone lesion Exclusion Criteria: Previous surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shervin Oskouei, MD
Organizational Affiliation
Emory University Department of Orthopaedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States

12. IPD Sharing Statement

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

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