Clinical Trial: Cell Therapy for Craniofacial Bone Defects

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Cell Therapy for Craniofacial Bone Defects

Brief Summary: The purpose of this research is to determine if a patient's own bone marrow tissue can help regenerate bone in the area of the jaw where an implant will be placed. The name of the process is called Bone Repair Cell (BRC) Therapy. A sample of bone marrow tissue will be collected and sent to a laboratory where it will be processed to form more cells. These new cells will then be transplanted in the regenerative site. The researchers are testing to see if these cells (BRC) will help form bone. The research will also determine if the implant will be more stable in the area with new bone growth.

Detailed Summary: Up to 20 (twenty) subjects who have alveolar defects secondary to clefts (n=10) or trauma (n=10), will be selected to participate in this study. Among the 20 patients, a total of up to 60 defect sites will be evaluated for bone regeneration following therapy, with each subject being evaluated in from one to four sites. Once enrolled, subjects from each of the two groups (cleft or trauma) will be randomly assigned to receive one of two possible treatments, traditional autogenous bone grafting or cell therapy (ixmyelocel-T)
Sponsor: University of Michigan

Current Primary Outcome: Bone Regeneration [ Time Frame: 4 months ]

The primary outcome variables for bone regeneration will be measured by histological and microcomputed tomographic (μCT) analyses at 4 months post-grafting.


Original Primary Outcome: Same as current

Current Secondary Outcome: Implant Stabilization [ Time Frame: 10 months ]

The ability of the dental implant fixtures to be loaded and remain stable for six months following implant loading (at 4 months) will be evaluated.


Original Secondary Outcome: Same as current

Information By: University of Michigan

Dates:
Date Received: June 8, 2012
Date Started: August 2012
Date Completion:
Last Updated: March 23, 2017
Last Verified: March 2017