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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This study has been withdrawn prior to enrollment.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

February 24, 2009
November 27, 2012
March 2009
March 2010   (final data collection date for primary outcome measure)
Time to fill bony defect [ Time Frame: Two to 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00851162 on ClinicalTrials.gov Archive Site
Adverse reaction from bone graft [ Time Frame: Immediately after surgery to one year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Using Mesenchymal Stem Cells to Fill Bone Void Defects in Patients With Benign Bone Lesions
Using Mesenchymal Stem Cells to Fill Bone Void Defects in Patients With Benign Bone Lesions

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

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Bone Neoplasms
  • 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
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ages > 11 years
  • Benign bone lesion

Exclusion Criteria:

  • Previous surgery
Both
11 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00851162
IRB00009762
No
Shervin Oskouei, Emory University
Emory University
Not Provided
Principal Investigator: Shervin Oskouei, MD Emory University Department of Orthopaedics
Emory University
November 2012

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