Trial record 3 of 154 for:    osteonecrosis

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aastrom Biosciences
ClinicalTrials.gov Identifier:
NCT00505219
First received: July 20, 2007
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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
Biological: Autologous Bone Repair Plasma
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-center Clinical Trial of the Application of Tissue Repair Cell (TRC) Therapy of Osteonecrosis of the Femoral Head

Resource links provided by NLM:


Further study details as provided by Aastrom Biosciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression (in months) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Osteonecrosis volume measured by MRI [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Pain and quality of life questionnaires [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: September 2007
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
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.
Biological: Autologous Bone Repair Plasma
Autologous plasma
Active Comparator: Control
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505219

Locations
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
Aastrom Biosciences
Investigators
Principal Investigator: Marc Hungerford, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Aastrom Biosciences
ClinicalTrials.gov Identifier: NCT00505219     History of Changes
Other Study ID Numbers: ABI 55-0705-1
Study First Received: July 20, 2007
Last Updated: January 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Aastrom Biosciences:
Osteonecrosis

Additional relevant MeSH terms:
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014