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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

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
Control Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.

Participant Flow:   Overall Study
    Treatment   Control
STARTED   12   12 
COMPLETED   12   12 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
Control Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
Total Total of all reporting groups

Baseline Measures
   Treatment   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   24 
Age 
[Units: Years]
Mean (Standard Deviation)
 46  (11)   53  (14)   50  (12) 
Gender 
[Units: Participants]
     
Female   6   8   14 
Male   6   4   10 
Region of Enrollment 
[Units: Participants]
     
United States   12   12   24 


  Outcome Measures

1.  Primary:   Bone Regeneration   [ Time Frame: 12 months after tooth extraction ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: dkaigler@umich.edu


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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