OsteonecrosisPhase 3ON-CORENCT00505219
Ixmyelocel-T Treatment of Patients With Osteonecrosis of the Femoral Head
A Phase 3 study testing Ixmyelocel-T in people with Osteonecrosis, run by Vericel Corporation at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteonecrosis
- What is being tested?
- Ixmyelocel-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2007to Dec 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Lutheran Medical Center
Brooklyn, New York, 11220
University of Minnesota Department of Orthopaedic Surgery
Minneapolis, Minnesota, 55455
About this study
Official title: Multi-center Clinical Trial of the Application of Ixmyelocel-T in the Treatment of Osteonecrosis of the Femoral Head
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.
Read the 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.
- Conditions
- Osteonecrosis
- Being tested
- Ixmyelocel-T, Standard of Care Only
- Keywords
- Osteonecrosis
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ixmyelocel-TBiological
Core decompression of the femoral head to remove necrotic tissue with Ixmyelocel-T given to treatment arm only.
Standard of Care OnlyOther
Core decompression of the femoral head to remove necrotic tissue
| Study group | Role | What they receive |
|---|---|---|
| Ixmyelocel-T | Experimental | Core decompression \& treatment with Tissue Repair Cells (TRCs), demineralized bone matrix bound in autologous plasma Receives: Biological: Ixmyelocel-T |
| Standard of Care Only | Active comparator | Core decompression, demineralized bone matrix bound in autologous plasma, without any TRCs. Receives: Other: Standard of Care Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (3)
Time to progression (in months)
Measured: 24 months
Osteonecrosis volume measured by MRI
Measured: 24 months
Pain and quality of life questionnaires
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteonecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vericel Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Hungerford, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505219
- Sponsor's protocol ID
- ABI 55-0705-1
- Acronym
- ON-CORE
- Status last verified
- Oct 2019
- First submitted
- 20 Jul 2007
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Clinical Trial of the Application of Ixmyelocel-T in the Treatment of Osteonecrosis of the Femoral Head
- ClinicalTrials.gov ID
- NCT00505219
- Acronym / sponsor ID
- ON-CORE / ABI 55-0705-1
- Conditions
- Osteonecrosis
- Keywords
- Osteonecrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Vericel CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ixmyelocel-T | Experimental | Biological: Ixmyelocel-TCore decompression \& treatment with Tissue Repair Cells (TRCs), demineralized bone matrix bound in autologous plasma |
| Standard of Care Only | Active comparator | Other: Standard of Care OnlyCore decompression, demineralized bone matrix bound in autologous plasma, without any TRCs. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ixmyelocel-TCore decompression of the femoral head to remove necrotic tissue with Ixmyelocel-T given to treatment arm only. | Biological | Ixmyelocel-T |
| Standard of Care OnlyCore decompression of the femoral head to remove necrotic tissue | Other | Standard of Care Only |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Hungerford, MD principal investigator
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ixmyelocel-T in people with Osteonecrosis, run by Vericel Corporation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.