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

This study has been withdrawn prior to enrollment.

(Study was not continued due to lack of enrollment.)

Sponsor:

Information provided by (Responsible Party):

Shervin Oskouei, Emory University

ClinicalTrials.gov Identifier:

NCT00851162

First received: February 24, 2009

Last updated: November 27, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 24, 2009

Last Updated Date

November 27, 2012

Start Date ^ICMJE

March 2009

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time to fill bony defect [ Time Frame: Two to 52 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00851162 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Adverse reaction from bone graft [ Time Frame: Immediately after surgery to one year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Bone Neoplasms

Intervention ^ICMJE

Biological: Trinity multipotent stem cells
Enough to fill voids which vary in size
Biological: Demineralized bone matrix(DBM)
Enough DBM to fill a bone void defect

Other Name: Grafton

Study Arm (s)

Experimental: Trinity
Trinity multipotent stem cells

Intervention: Biological: Trinity multipotent stem cells
Active Comparator: Demineralized bone matrix
Demineralized bone matrix

Intervention: Biological: Demineralized bone matrix(DBM)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Estimated Completion Date

March 2010

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Ages > 11 years
Benign bone lesion

Exclusion Criteria:

Previous surgery

Gender

Both

Ages

11 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00851162

Other Study ID Numbers ^ICMJE

IRB00009762

Has Data Monitoring Committee

Responsible Party

Shervin Oskouei, Emory University

Study Sponsor ^ICMJE

Emory University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Shervin Oskouei, MD

Emory University Department of Orthopaedics

Information Provided By

Emory University

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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