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

NCT00755911 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-07-03

Study results available
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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.

Conditions

  • Alveolar Bone Loss

Interventions

BIOLOGICAL

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.

DEVICE

Control

Control subjects only receive standard gelfoam carrier. It promotes healing after tooth extraction

Sponsors & Collaborators

Principal Investigators

  • Darnell Kaigler, DDS, MS, PhD · University of Michigan Department of Periodontics and Oral Medicine

  • William V Giannobile, DDS, DMedSc · University of Michigan Center for Oral Health Research

  • Steven Goldstein, PhD · University of Michigan Henry Ruppenthal Family Professor of Orthopaedic Surgery and Bioengineering

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-12-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00755911 on ClinicalTrials.gov