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Sponsors and Collaborators: |
University of Michigan Aastrom Biosciences |
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Information provided by: | University of Michigan |
ClinicalTrials.gov Identifier: | NCT00755911 |
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.
Condition | Intervention | Phase |
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Alveolar Bone Defects |
Biological: Tissue Repair Cell therapy Device: Tissue Repair Cells (TRC) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy |
Estimated Enrollment: | 24 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
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Biological: Tissue Repair Cell therapy
Processed bone marrow aspirates
Device: Tissue Repair Cells (TRC)
30-50 ml of bone marrow is aspirated from subject and processed into TRC autologous bone marrow tissue graft. 10ml of TRC will be absorbed onto gelfoam carrier and placed in extraction socket. Control subjects only receive standard gelfoam carrier. Promotes proper healing after tooth extraction
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2: Active Comparator
Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
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Device: Tissue Repair Cells (TRC)
30-50 ml of bone marrow is aspirated from subject and processed into TRC autologous bone marrow tissue graft. 10ml of TRC will be absorbed onto gelfoam carrier and placed in extraction socket. Control subjects only receive standard gelfoam carrier. Promotes proper healing after tooth extraction
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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.
Ages Eligible for Study: | 20 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
4.5.10 Additionally, individuals who have a medical history significant for diabetes will not be included in the study.
The following additional exclusion criteria for regenerative sites are in alignment with those described and adapted for using BMPs to regenerate buccal wall defects (Fiorellini, Howell et al. 2005):
Contact: Lana Huffman | 734-998-6721 | lanahuff@umich.edu |
Contact: Chereen Mroz | 734-998-1468 | chereen@umich.edu |
United States, Michigan | |
University of Michigan Center for Oral Health Research | Recruiting |
Ann Arbor, Michigan, United States, 48106 | |
Contact: Lana Huffman 734-998-6721 lanahuff@umich.edu | |
Contact: Emily Thorpe, BS 734-998-1376 emthorpe@umich.edu | |
Principal Investigator: Darnell Kaigler, DDS, MS, PhD | |
Sub-Investigator: William V Giannobile, DDS, DMedSc | |
Sub-Investigator: Steven Goldstein, PhD |
Principal Investigator: | Darnell Kaigler, DDS, MS, PhD | University of Michigan Department of Periodontics and Oral Medicine |
Study Chair: | William V Giannobile, DDS, DMedSc | University of Michigan Center for Oral Health Research |
Study Chair: | Steven Goldstein, PhD | University of Michigan Henry Ruppenthal Family Professor of Orthopaedic Surgery and Bioengineering |
Responsible Party: | University of Michigan Department of Periodontics and Oral Medicine ( Darnell Kaigler, DDS, MS, PhD ) |
Study ID Numbers: | 2008-02 |
Study First Received: | September 17, 2008 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00755911 |
Health Authority: | United States: Food and Drug Administration |
dental tooth implant extraction |
Oral Surgical Procedures |
Gelatin Sponge, Absorbable |