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This study has been withdrawn prior to enrollment.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
  Purpose

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


Condition Intervention Phase
Bone Neoplasms
Biological: Trinity multipotent stem cells
Biological: Demineralized bone matrix(DBM)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Using Mesenchymal Stem Cells to Fill Bone Void Defects in Patients With Benign Bone Lesions

Resource links provided by NLM:


Further study details as provided by Emory University:

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

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

Enrollment: 0
Study Start Date: March 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trinity
Trinity multipotent stem cells
Biological: Trinity multipotent stem cells
Enough to fill voids which vary in size
Active Comparator: Demineralized bone matrix
Demineralized bone matrix
Biological: Demineralized bone matrix(DBM)
Enough DBM to fill a bone void defect
Other Name: Grafton

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.

  Eligibility

Ages Eligible for Study:   11 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages > 11 years
  • Benign bone lesion

Exclusion Criteria:

  • Previous surgery
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00851162

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30306
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Shervin Oskouei, MD Emory University Department of Orthopaedics
  More Information

No publications provided

Responsible Party: Shervin Oskouei, MD, Emory University
ClinicalTrials.gov Identifier: NCT00851162     History of Changes
Other Study ID Numbers: IRB00009762
Study First Received: February 24, 2009
Last Updated: November 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Bone defect
Benign bone lesions
Stem cells

Additional relevant MeSH terms:
Bone Neoplasms
Bone Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 22, 2014