COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Ixmyelocel-T Treatment of Patients With Osteonecrosis of the Femoral Head (ON-CORE)

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. Identifier: NCT00505219
Recruitment Status : Completed
First Posted : July 23, 2007
Last Update Posted : October 21, 2019
Information provided by (Responsible Party):
Vericel Corporation

Brief Summary:
The purpose of this study is to determine if Ixmyelocel-T grafting with demineralized bone matrix bound in autologous plasma after core decompression surgery is superior to core decompression with demineralized bone matrix bound in autologous plasma 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 or disease Intervention/treatment Phase
Osteonecrosis Biological: Ixmyelocel-T Other: Standard of Care Only Phase 3

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteonecrosis

Arm Intervention/treatment
Experimental: Ixmyelocel-T
Core decompression & treatment with Tissue Repair Cells (TRCs), demineralized bone matrix bound in autologous plasma
Biological: Ixmyelocel-T
Core decompression of the femoral head to remove necrotic tissue with Ixmyelocel-T given to treatment arm only.

Active Comparator: Standard of Care Only
Core decompression, demineralized bone matrix bound in autologous plasma, without any TRCs.
Other: Standard of Care Only
Core decompression of the femoral head to remove necrotic tissue

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Time to progression (in months) [ Time Frame: 24 months ]
  2. Osteonecrosis volume measured by MRI [ Time Frame: 24 months ]
  3. Pain and quality of life questionnaires [ Time Frame: 24 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • UPenn (Steinberg) classification of osteonecrosis, inclusive of Stages IIB and IIC. Diagnosis will be based on magnetic resonance imaging (MRI).
  • Modified index of necrotic extent < 40
  • Idiopathic and non-idiopathic osteonecrosis.
  • No infection in affected bones at the time of surgery.
  • Patient competent to give informed consent.
  • Normal organ and marrow function defined as:

    • Leukocytes ≥ 3000/µL;
    • Absolute neutrophil count ≥ 1500/µL;
    • Platelets ≥ 140,000/µL;
    • Serum AST (SGOT)/ALT (SGPT) < 2.5 X institutional standard range;
    • Serum creatinine within normal limits, based on clinical laboratory normal range.
  • Female patients not pregnant or lactating.
  • Patients with a history of corticosteroids or on active therapy, will only be eligible for enrollment if corticosteroid use is suspended for 1 month prior and 6 months after cell therapy and surgery.
  • Patients who have been treated with oral bisphosphonates are eligible for the trial if treatment was stopped at least 6 months prior to enrollment.

Exclusion Criteria:

  • Stages IA, IB, IC, IIA, IIIA or more severe femoral head osteonecrosis, primarily based on diagnosis by MRI.
  • Flattening of the femur head (UPenn Stage IV) or articular cartilage collapse at the time of core decompression surgery.
  • Septic arthritis; stress fracture, or non-osteonecrosis metabolic bone diseases (e.g., Paget's disease of bone, osteogenesis imperfecta, primary hyperparathyroidism, fibrous dysplasia [monostotic, polyostotic McCune-Albright syndrome] and osteopetrosis).
  • Any active bisphosphonate treatment or any history of intravenous (IV) treatment
  • HIV, syphilis, positive at time of screening.
  • Active hepatitis B or hepatitis C infection at the time of screening
  • Known allergies to protein products (horse or bovine serum, or porcine trypsin).
  • Patients who will require continuous, systemic, high dose corticosteroid therapy (more than 7.5 mg/day) within 6 months after surgery.
  • Patients in active treatment for cancer or blood dyscrasia, or have received chemotherapy, radiotherapy or immunotherapy in the past 2 years.
  • Immunodeficiency diseases.
  • Participation in another clinical study in the past 30 days or concurrent participation in another clinical trial.
  • History of regular alcohol consumption exceeding 2 drinks/day (1 drink = 5 oz [150 mL] of wine or 12 oz [360 mL] of beer or 1.5 oz [45 mL] of hard liquor) within 6 months of screening and/or history of illicit drug use.
  • MRI-incompatible internal devices (pacemakers, aneurysm clips, etc)
  • Body mass index (BMI) of 40 Kg/m2 or greater
  • Patients unable to tolerate general anesthesia defined as an American Society of Anesthesiologists (ASA) criteria of > 2
  • Patients with poorly controlled diabetes mellitus (HbA1C > 8%), or with peripheral neuropathy, or known concomitant vascular problems.
  • Patients receiving treatment with hematopoietic growth factors or anti-vasculogenesis or anti-angiogenesis treatment
  • Traumatic osteonecrosis

Information from the National Library of Medicine

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 identifier (NCT number): NCT00505219

Layout table for location information
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
Sponsors and Collaborators
Vericel Corporation
Layout table for investigator information
Principal Investigator: Marc Hungerford, MD Johns Hopkins University
Layout table for additonal information
Responsible Party: Vericel Corporation Identifier: NCT00505219    
Other Study ID Numbers: ABI 55-0705-1
First Posted: July 23, 2007    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Keywords provided by Vericel Corporation:
Additional relevant MeSH terms:
Layout table for MeSH terms
Legg-Calve-Perthes Disease
Bone Diseases
Musculoskeletal Diseases
Pathologic Processes
Femur Head Necrosis