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Trial record 2 of 2 for:    15246727 [PUBMED-IDS]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00755911
Recruitment Status : Completed
First Posted : September 19, 2008
Results First Posted : April 15, 2014
Last Update Posted : July 3, 2015
Sponsor:
Collaborator:
Vericel Corporation
Information provided by (Responsible Party):
Darnell Kaigler, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Alveolar Bone Loss
Interventions Biological: Tissue Repair Cells (TRC)
Device: Control
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Control
Hide Arm/Group Description Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
Period Title: Overall Study
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title Treatment Control Total
Hide Arm/Group Description Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy. Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
46  (11) 53  (14) 50  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
6
  50.0%
8
  66.7%
14
  58.3%
Male
6
  50.0%
4
  33.3%
10
  41.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 24 participants
12 12 24
1.Primary Outcome
Title Bone Regeneration
Hide Description

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)
Time Frame 12 months after tooth extraction
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tissue Repair Cells (TRC) Control
Hide Arm/Group Description:
Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: % bone height
79  (10) 63  (16)
2.Secondary Outcome
Title Number of Participants Who Successfully Received Dental Implant Fixtures
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tissue Repair Cells (TRC) Control
Hide Arm/Group Description:
Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
Overall Number of Participants Analyzed 12 12
Measure Type: Number
Unit of Measure: participants
12 12
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental: Tissue Repair Cell (TRC) Sham Comparator: Control
Hide Arm/Group Description Subjects will receive TRC therapy plus Gelfoam carrier Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
All-Cause Mortality
Experimental: Tissue Repair Cell (TRC) Sham Comparator: Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Experimental: Tissue Repair Cell (TRC) Sham Comparator: Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      3/12 (25.00%)    
Gastrointestinal disorders     
Gastroenteritis  [1]  0/12 (0.00%)  0 1/12 (8.33%)  1
Injury, poisoning and procedural complications     
Assault injury  [2]  0/12 (0.00%)  0 1/12 (8.33%)  1
Surgical and medical procedures     
Stomach Ulcer * [3]  0/12 (0.00%)  0 1/12 (8.33%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Hospitalized 3 days
[2]
Hospitalized for 2-3 days.
[3]
Hospitalized for 19 days.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Experimental: Tissue Repair Cell (TRC) Sham Comparator: Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/12 (83.33%)      11/12 (91.67%)    
Blood and lymphatic system disorders     
Infection *  0/12 (0.00%)  0 1/12 (8.33%)  1
Acute pharyngitis * [1]  0/12 (0.00%)  0 1/12 (8.33%)  1
Strep throat *  0/12 (0.00%)  0 1/12 (8.33%)  1
Eye disorders     
Pink eye *  1/12 (8.33%)  1 0/12 (0.00%)  0
Gastrointestinal disorders     
Nausea from medication *  1/12 (8.33%)  1 0/12 (0.00%)  0
General disorders     
Flu *  0/12 (0.00%)  0 1/12 (8.33%)  1
Acute pharyngitis  [2]  0/12 (0.00%)  0 1/12 (8.33%)  1
Density in lungs   0/12 (0.00%)  0 1/12 (8.33%)  1
Infections and infestations     
Post surgical infection *  0/12 (0.00%)  0 1/12 (8.33%)  1
Pneumonia *  0/12 (0.00%)  0 1/12 (8.33%)  1
Injury, poisoning and procedural complications     
Cut tendon in hand *  0/12 (0.00%)  0 1/12 (8.33%)  1
Fell down stairs and tore tendons in right foot *  1/12 (8.33%)  1 0/12 (0.00%)  0
Choking while eating *  0/12 (0.00%)  0 1/12 (8.33%)  1
Pain and leg cramping during aspiration   1/12 (8.33%)  1 0/12 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Pulled leg muscle *  1/12 (8.33%)  1 0/12 (0.00%)  0
Dislocated knee *  0/12 (0.00%)  0 1/12 (8.33%)  1
Discomfort with mouth movement *  1/12 (8.33%)  1 0/12 (0.00%)  0
Slight incision opening *  1/12 (8.33%)  1 0/12 (0.00%)  0
Bruising aspiration site *  1/12 (8.33%)  1 0/12 (0.00%)  0
Moderate-severe swelling following extraction *  0/12 (0.00%)  0 1/12 (8.33%)  1
Mild swelling and bruising following extraction *  0/12 (0.00%)  0 1/12 (8.33%)  1
Fractured tooth *  0/12 (0.00%)  0 1/12 (8.33%)  1
Moderate bruising and swelling following implant uncovery *  0/12 (0.00%)  0 1/12 (8.33%)  1
Bruising following extraction *  1/12 (8.33%)  1 0/12 (0.00%)  0
Gout *  1/12 (8.33%)  1 0/12 (0.00%)  0
Post-op bleeding at aspiration site *  1/12 (8.33%)  1 0/12 (0.00%)  0
Bone exposure following extraction * [3]  1/12 (8.33%)  1 0/12 (0.00%)  0
Nervous system disorders     
Sensitive tooth *  0/12 (0.00%)  0 1/12 (8.33%)  1
Distress from theft *  0/12 (0.00%)  0 1/12 (8.33%)  1
Sensitivity to sweet and cold *  1/12 (8.33%)  1 0/12 (0.00%)  0
Skin and subcutaneous tissue disorders     
Post extraction soreness *  1/12 (8.33%)  1 0/12 (0.00%)  0
Fractured tooth *  1/12 (8.33%)  1 0/12 (0.00%)  0
Discomfort near surgical site *  1/12 (8.33%)  1 0/12 (0.00%)  0
Upper lip tingling *  1/12 (8.33%)  1 0/12 (0.00%)  0
Oral conidition requiring multiple extractions *  1/12 (8.33%)  1 0/12 (0.00%)  0
Fractured tooth *  0/12 (0.00%)  0 1/12 (8.33%)  1
Shingles *  0/12 (0.00%)  0 1/12 (8.33%)  1
Slight incision opening *  1/12 (8.33%)  1 0/12 (0.00%)  0
Slight incision opening *  0/12 (0.00%)  0 1/12 (8.33%)  1
Slight incision opening *  0/12 (0.00%)  0 1/1 (100.00%)  1
Supporation from tip of nose *  0/12 (0.00%)  0 1/12 (8.33%)  1
Post-op bleeding at aspiration site *  1/12 (8.33%)  1 0/12 (0.00%)  0
Tissue near extaction site loose causing some tenderness *  1/12 (8.33%)  1 0/12 (0.00%)  0
Soreness in extraction site *  1/12 (8.33%)  1 0/12 (0.00%)  0
Swelling following extraction *  0/12 (0.00%)  0 1/12 (8.33%)  1
Bruising following extraction *  0/12 (0.00%)  0 1/12 (8.33%)  1
Bruising and swelling following extraction *  1/12 (8.33%)  1 0/12 (0.00%)  0
Swelling following extraction *  1/12 (8.33%)  1 0/12 (0.00%)  0
Social circumstances     
Anxiety prior to procedure *  1/12 (8.33%)  1 0/12 (0.00%)  0
Relocated to another state due to personal issues *  1/12 (8.33%)  1 0/12 (0.00%)  0
Surgical and medical procedures     
Soreness following aspiration *  1/12 (8.33%)  1 0/12 (0.00%)  0
Restoration defect *  1/12 (8.33%)  1 0/12 (0.00%)  0
Swelling and tenderness in tooth extraction area *  0/12 (0.00%)  0 1/12 (8.33%)  1
Fractured tooth extracted *  0/12 (0.00%)  0 1/12 (8.33%)  1
Post extraction pain *  0/12 (0.00%)  0 1/12 (8.33%)  1
Open incision due to sutures coming out *  1/12 (8.33%)  1 0/12 (0.00%)  0
Pressure in sinus following extraction *  1/12 (8.33%)  1 0/12 (0.00%)  0
Fractured teeth extracted *  1/12 (8.33%)  1 0/12 (0.00%)  0
Non-restorable tooth extracted *  1/12 (8.33%)  1 0/12 (0.00%)  0
Swelling and oozing following extraction *  0/12 (0.00%)  0 1/12 (8.33%)  1
Discomfort *  0/12 (0.00%)  0 1/12 (8.33%)  1
Fractured tooth extracted *  0/12 (0.00%)  0 1/1 (100.00%)  1
Non-restorable tooth extracted *  0/12 (0.00%)  0 1/12 (8.33%)  1
Implant cover screw fell out and was replaced *  0/12 (0.00%)  0 1/12 (8.33%)  1
Fractured tooth extracted *  1/12 (8.33%)  1 0/12 (0.00%)  0
Failed aspiration *  1/12 (8.33%)  1 0/12 (0.00%)  0
Non-restorable teeth extracted *  0/12 (0.00%)  0 1/12 (8.33%)  1
Crown fell off *  0/12 (0.00%)  0 1/12 (8.33%)  1
Broken upper flipper *  0/12 (0.00%)  0 1/12 (8.33%)  1
Implant cover screw fell out *  1/12 (8.33%)  1 0/12 (0.00%)  0
Fractured tooth *  1/12 (8.33%)  1 0/12 (0.00%)  0
Discomfort following implant uncovery *  0/12 (0.00%)  0 1/12 (8.33%)  1
Post-op bleeding at aspiration site *  1/12 (8.33%)  1 0/12 (0.00%)  0
Fractured teeth extracted   1/12 (8.33%)  1 0/12 (0.00%)  0
Surgical treatment for addiction   1/12 (8.33%)  1 0/12 (0.00%)  0
Crown fell off   0/12 (0.00%)  0 1/12 (8.33%)  1
Broken flipper   1/12 (8.33%)  1 0/12 (0.00%)  0
Failed aspiration   1/12 (8.33%)  1 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
PCP
[2]
ER
[3]
non-study area
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Darnell Kaigler
Organization: University of Michigan
Phone: 734-998-1468
Publications:
Responsible Party: Darnell Kaigler, University of Michigan
ClinicalTrials.gov Identifier: NCT00755911     History of Changes
Other Study ID Numbers: 2008-02
First Submitted: September 17, 2008
First Posted: September 19, 2008
Results First Submitted: January 7, 2013
Results First Posted: April 15, 2014
Last Update Posted: July 3, 2015