Ixmyelocel-T Treatment of Patients With Osteonecrosis of the Femoral Head

NCT00505219 | Completed Phase 3

• 1 other identifier: ABI 55-0705-1
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

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.

Conditions

Osteonecrosis

Keywords

Osteonecrosis

Outcome Measures

Primary Outcomes (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.

  24 months

Secondary Outcomes (3)

• Time to progression (in months)

  24 months

• Osteonecrosis volume measured by MRI

  24 months

• Pain and quality of life questionnaires

  24 months

Study Arms (2)

Ixmyelocel-T

EXPERIMENTAL

Core decompression \& treatment with Tissue Repair Cells (TRCs), demineralized bone matrix bound in autologous plasma

Biological: Ixmyelocel-T

Standard of Care Only

ACTIVE COMPARATOR

Core decompression, demineralized bone matrix bound in autologous plasma, without any TRCs.

Other: Standard of Care Only

Interventions

Ixmyelocel-T BIOLOGICAL

Core decompression of the femoral head to remove necrotic tissue with Ixmyelocel-T given to treatment arm only.

Ixmyelocel-T

Standard of Care Only OTHER

Core decompression of the femoral head to remove necrotic tissue

Standard of Care Only

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vericel Corporation: lead

Study Sites (3)

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

University of Minnesota Department of Orthopaedic Surgery

Minneapolis, Minnesota, 55455, United States

Location

Lutheran Medical Center

Brooklyn, New York, 11220, United States

Location

MeSH Terms

Conditions

Osteonecrosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Hungerford, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2007
• First Posted: July 23, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 21, 2019

Record last verified: 2019-10

Locations

US (3)