Ixmyelocel-T Treatment of Patients With Osteonecrosis of the Femoral Head (ON-CORE)
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|ClinicalTrials.gov Identifier: NCT00505219|
Recruitment Status : Completed
First Posted : July 23, 2007
Last Update Posted : June 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteonecrosis||Biological: Ixmyelocel-T Other: Standard of Care Only||Phase 2|
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.
- The first patient group is the Treatment Group and will receive core decompression and treatment with BRCs and demineralized bone matrix bound in autologous plasma, and
- The second patient group is the Control Group and will receive core decompression and demineralized bone matrix bound in autologous plasma, without any BRCs.
- Enrollment: With an anticipated drop-out rate of 10% in up to twenty (20) sites, a total of approximately 135 patients will be enrolled and randomized to obtain 120 evaluable patients (75 for the TRC treatment group and 45 for the Control treatment group).
- Primary endpoint: The percentage of patients progressing to a more severe UPenn disease stage (Stage II to III or higher) between 0 and 24 months will be the primary efficacy variable to demonstrate TRC therapy is superior to Control therapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Multi-center Clinical Trial of the Application of Ixmyelocel-T in the Treatment of Osteonecrosis of the Femoral Head|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||December 2010|
The Treatment arm of the study will receive study cellular product.
Core decompression of the femoral head to remove necrotic tissue with Ixmyelocel-T given to treatment arm only.
Active Comparator: Standard of Care Only
The Control arm of the study will receive standard of care therapy only.
Other: Standard of Care Only
Core decompression of the femoral head to remove necrotic tissue
- The progression of patients with UPenn Stage IIB or IIC disease to a more severe stage based on all available x-ray and MRI imaging. Patients who have a definitive procedure but do not have a valid assessment will be considered to have progressed. [ Time Frame: 24 months ]
- Time to progression (in months) [ Time Frame: 24 months ]
- Osteonecrosis volume measured by MRI [ Time Frame: 24 months ]
- Pain and quality of life questionnaires [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00505219
|United States, Maryland|
|Sinai Hospital of Baltimore|
|Baltimore, Maryland, United States, 21215|
|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|
|Principal Investigator:||Marc Hungerford, MD||Johns Hopkins University|