Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Aastrom Biosciences |
---|---|
Information provided by: | Aastrom Biosciences |
ClinicalTrials.gov Identifier: | NCT00505219 |
The purpose of this study is to determine if autologous Bone Repair Cell (BRC) grafting with demineralized bone matrix bound in autologous plasma after core decompression surgery (BRC therapy) is superior to core decompression with demineralized bone matrix bound in autologous plasma (Control therapy) in preventing progression of osteonecrosis to a more severe disease stage (Stage II to III or higher) from the time of surgery until 24 months later, in patients with University of Pennsylvania (UPenn) Stage IIB or C disease at diagnosis.
Condition | Intervention | Phase |
---|---|---|
Osteonecrosis |
Procedure: Core decompression |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Multi-Center Clinical Trial of the Application of Tissue Repair Cell (TRC) Therapy of Osteonecrosis of the Femoral Head |
Estimated Enrollment: | 120 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Treatment: Experimental
The Treatment arm of the study will receive standard of care therapy and study cellular product.
|
Procedure: Core decompression
Core decompression of the femoral head to remove necrotic tissue for both arms of the study with BRCs given to Treatment arm only.
|
Control: Active Comparator
The Control arm of the study will receive standard of care therapy only.
|
Procedure: Core decompression
Core decompression of the femoral head to remove necrotic tissue for both arms of the study with BRCs given to Treatment arm only.
|
This study is an event-driven, multi-center, prospective, independent observer-blinded, controlled, randomized Phase III clinical trial enrolling patients diagnosed with University of Pennsylvania (Steinberg) Classification Stage IIB or C osteonecrosis of the femoral head.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Normal organ and marrow function defined as:
Exclusion Criteria:
United States, Maryland | |
Sinai Hospital of Baltimore | |
Baltimore, Maryland, United States, 21215 | |
Johns Hopkins University Orthopaedics at Good Samaritan Hospital | |
Baltimore, Maryland, United States, 21239 | |
United States, Minnesota | |
University of Minnesota Department of Orthopaedic Surgery | |
Minneapolis, Minnesota, United States, 55455 | |
United States, New York | |
Lutheran Medical Center | |
Brooklyn, New York, United States, 11220 | |
United States, Virginia | |
University of Virginia Health System Department of Orthopaedic Surgery | |
Charlottesville, Virginia, United States, 22903 |
Principal Investigator: | Marc Hungerford, MD | Johns Hopkins University |
Responsible Party: | Aastrom Biosciences, Inc. ( Elmar Burchardt, Vice President, Medical Affairs ) |
Study ID Numbers: | ABI 55-0705-1 |
Study First Received: | July 20, 2007 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00505219 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Osteonecrosis |
Necrosis Musculoskeletal Diseases Osteonecrosis Bone Diseases |
Necrosis Pathologic Processes Musculoskeletal Diseases Osteonecrosis Bone Diseases |