Clinical Trial: Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy

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

Official Title: Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy

Brief Summary: The purpose of this research is to determine if a subject's own bone marrow tissue can help regenerate bone in the area of his/her jaw where a tooth has been removed using Tissue Repair Cell (TRC) Therapy.

Detailed Summary: A sample of the subject's bone marrow tissue will be collected and sent to a laboratory where it will be processed to form cells. The new cells are transplanted into the tooth socket after the tooth has been removed. The researchers are testing to see if these cells (TRC) will help form bone. The research will also determine if the implant the subject receives will be more stable in the area with new bone growth.
Sponsor: University of Michigan

Current Primary Outcome: Bone Regeneration [ Time Frame: 12 months after tooth extraction ]

The primary objective of this study is to determine whether the placement of Tissue Repair Cells (TRCs) at the time of tooth extraction can safely and effectively promote bone regeneration in alveolar bone defects created by tooth extraction.

  • Safety was assessed through adverse event reporting
  • Bone regeneration was assessed through measures of bone mineral density and bone volume fraction of biopsied regenerated bone tissue. Bone regeneration was also measured through radiographic analysis of relative bone height gain (% of the bone height regenerated relative to the height before tooth extraction)


Original Primary Outcome: The primary objective of this study is to determine whether the placement of Tissue Repair Cells (TRCs) at the time of tooth extraction can safely and effectively promote bone regeneration in alveolar bone defects created by tooth extraction [ Time Frame: 12 months after tooth extraction ]

Current Secondary Outcome: Number of Participants Who Successfully Received Dental Implant Fixtures [ Time Frame: 12 months after tooth extraction ]

The secondary objective is to determine if Tissue Repair Cell therapy regenerates bone enabling the installation and stability of dental implant fixtures


Original Secondary Outcome: The secondary objective is to determine if Tissue Repair Cell therapy regenerates bone enabling the installation and stability of dental implant fixtures [ Time Frame: 12 months after tooth extraction ]

Information By: University of Michigan

Dates:
Date Received: September 17, 2008
Date Started: June 2008
Date Completion:
Last Updated: May 28, 2015
Last Verified: May 2015