The purpose of this research is to determine if one's own bone marrow tissue can help regenerate (grow) 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 or sinus floor augmentation site. The researchers are testing to see if these cells (BRC) will help form bone indicating. The research will also determine if the implant will be more stable in the area with new bone growth.
The overall aim is to promote bone regeneration, using Aastrom's proprietary Adult Stem Cell Therapy (AST) developed collaboratively with the University of Michigan, to enable placement of dental implants in patients who lack adequate alveolar bone. This project addresses specifically the placement of dental implants following bone regenerative sinus floor augmentation. This novel therapy mitigates the risks of other therapies, providing additional benefits of adequate cell numbers for high quality bone regeneration, and has the potential to become the new standard of care. In Aastrom's patented manufacturing technology, iliac bone marrow aspirates are expanded ex-vivo to enrich for adult multipotent cells (Bone Repair Cells- BRC) capable of regenerating bone and blood vessels. BRC will then be mixed with bone matrix graft extender, beta-tricalcium phosphate (β-TCP), before their implantation into the regenerative site.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.
sinus augmentation, BRC application, dental implant
Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States
Bone Mineral Density of Bone Core
Bone mineral density of bone core was measured by histological and µCT analyses
Time frame: 4 months
Bone Volume Fraction of Bone Core
Bone volume fraction of bone core histological and µCT analyses
Time frame: 4 months
Change in Linear Radiographic Bone Height
Change in linear radiographic bone heights were measured before and after bone graft reconstruction
Time frame: Screening and 1 week post-op from baseline
Change in Sinus Bone Volume
CBCT was used to evaluated 3-D changes in the bone volume within the treated areas of the sinus cavity
Time frame: Pre-baseline and within 2 weeks of 4 Month visit
Final Bone Volume: Initial Graft Volume Ratio
Bone volume fraction of bone core histological and µCT analyses
Time frame: 4 months
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