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Saturday, 03/28/2009 6:12:02 AM

Saturday, March 28, 2009 6:12:02 AM

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Aastrom Biosciences | Open Studies| Completed
ClinicalTrials.gov

Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy
Condition: Alveolar Bone Defects
Interventions: Biological: Tissue Repair Cell therapy; Device: Tissue Repair Cells (TRC)
Sponsors: University of Michigan; Aastrom Biosciences
Phases: Phase I / Phase II
Number Enrolled: 24
Funded By: OTHER / INDUSTRY
NCT ID: NCT00755911
Completion Date: March 2010


Feasibility Study of Aastrom Tissue Repair Cells to Treat Non-Union Fractures.
Conditions: Fracture, Ununited; Pseudarthrosis
Interventions: Procedure: Fracture surgery; Drug: Cultured Bone Marrow Tissue
Sponsor: Aastrom Biosciences
Phases: Phase I / Phase II
Number Enrolled: 36
Funded By: INDUSTRY
NCT ID: NCT00424567
Completion Date: June 2007


Use of TRC Autologous Bone Marrow Cells in Posterolateral Lumbar Spine Fusion

Condition: Single Level Posterolateral Spinal Fusion
Interventions: Procedure: Bone Repair Cells (BRCs) with allogeneic, demineralized bone matrix; Procedure: Spine fusion with autologous bone graft
Sponsor: Aastrom Biosciences
Phases: Phase I / Phase II
Number Enrolled: 2
Funded By: INDUSTRY
NCT ID: NCT00797550
Completion Date: October 2008


Use of Vascular Repair Cells (VRC) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia

Condition: Peripheral Arterial Disease
Interventions: Biological: autologous bone marrow cells; Biological: electrolyte solution (without cells)
Sponsor: Aastrom Biosciences
Phase: Phase II
Number Enrolled: 150
Funded By: INDUSTRY
NCT ID: NCT00468000
Completion Date: June 2011


Cardiac Repair Cell (CRC) Treatment of Patients With Heart Failure Due to Dilated Cardiomyopathy (IMPACT-DCM)

Condition: Dilated Cardiomyopathy
Intervention: Biological: Cardiac Repair Cells (CRCs)
Sponsor: Aastrom Biosciences
Phase: Phase II
Number Enrolled: 40
Funded By: INDUSTRY
NCT ID: NCT00765518
Completion Date: June 2010

UPDATE: Tuesday March 3, 2009,
FDA Removes Clinical Hold From Aastrom Phase II IMPACT-DCM Clinical Trial

“… patient enrollment would resume in all four clinical sites and expects to complete it by the end of the year.
Activation of the fifth clinical site is underway.”


Bone Repair Cell (BRC) Treatment of Patients With Osteonecrosis of the Femoral Head

Condition: Osteonecrosis
Intervention: Procedure: Core decompression
Sponsor: Aastrom Biosciences
Phase: Phase III
Number Enrolled: 120
Funded By: INDUSTRY
NCT ID: NCT00505219
Completion Date: June 2011


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