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

Phase 2/Phase 3
11 Years
Not Enrolling
Bone Neoplasms

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Trial Information

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

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.

Inclusion Criteria:

- Ages > 11 years

- Benign bone lesion

Exclusion Criteria:

- Previous surgery

Type of Study:


Study Design:

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

Outcome Measure:

Time to fill bony defect

Outcome Time Frame:

Two to 52 weeks

Safety Issue:


Principal Investigator

Shervin Oskouei, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Department of Orthopaedics


United States: Institutional Review Board

Study ID:




Start Date:

March 2009

Completion Date:

March 2010

Related Keywords:

  • Bone Neoplasms
  • Bone defect
  • Benign bone lesions
  • Stem cells
  • Bone Neoplasms
  • Neoplasms



Emory University Atlanta, Georgia  30322