Using Mesenchymal Stem Cells to Fill Bone Void Defects in Patients With Benign Bone Lesions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00851162|
Recruitment Status : Withdrawn (Study was not continued due to lack of enrollment.)
First Posted : February 25, 2009
Last Update Posted : November 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Bone Neoplasms||Biological: Trinity multipotent stem cells Biological: Demineralized bone matrix(DBM)||Phase 2 Phase 3|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Using Mesenchymal Stem Cells to Fill Bone Void Defects in Patients With Benign Bone Lesions|
|Study Start Date :||March 2009|
|Estimated Primary Completion Date :||March 2010|
|Estimated Study Completion Date :||March 2010|
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
- Time to fill bony defect [ Time Frame: Two to 52 weeks ]
- Adverse reaction from bone graft [ Time Frame: Immediately after surgery to one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851162
|United States, Georgia|
|Atlanta, Georgia, United States, 30306|
|Principal Investigator:||Shervin Oskouei, MD||Emory University Department of Orthopaedics|