OsteonecrosisPhase 1NCT01198080
Evaluate the Effect of Bone Marrow Derived Cd133+ Cells in Patient With Osteonecrosis of Femoral Head
A Phase 1 study testing CD133+ cells in people with Osteonecrosis, run by Royan Institute at 1 site in Iran.
Trial summary
Avascular necrosis is a disease where there is cellular death (necrosis) of bone components due to interruption of the blood supply. Without blood, the bone tissue dies and the bone collapses. If avascular necrosis involves the bones of a joint, it often leads to destruction of the joint articular surfaces. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteonecrosis
- What is being tested?
- CD133+ cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIran
- Study dates
- Aug 2009to Jun 2013
- Phase
- Phase 1
- 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 65 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.
- 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
1 site in 1 country.
About this study
Official title: Bone Marrow Derived CD133+ Stem Cells Transplantation in Femoral Head Osteonecrosis
Avascular necrosis is a disease where there is cellular death (necrosis) of bone components due to interruption of the blood supply. Without blood, the bone tissue dies and the bone collapses. If avascular necrosis involves the bones of a joint, it often leads to destruction of the joint articular surfaces. Avascular necrosis is especially common in the hip joint. A variety of methods are now used to treat avascular necrosis the most common being the total hip replacement, or THR.A new, more promising treatment is hip resurfacing or metal on metal (MOM) resurfacing.Another treatment is utilization of bone marrow derived stem cells.these stem cells can provide angiogenic factors and osteogenic cytokine to improve angiogenesis and bone formation.
Read the detailed description
A vascular necrosis of femoral head is a debilitating disease resulting from interruption of blood supply to the bone. This pathologic process results in the death of marrow and osteocytes and, in its final stage, femoral head collapse. The most widespread treatment in the early stage of this disease is core decompression. This surgical procedure involves drilling into the femoral neck through the necrotic area, which reduces pressure within the bone and allows more blood vessels to form. This study is designed to evaluate the clinical safety and efficacy of CD133+ enriched bone marrow infusion adjacent with core decompression in patients with a vascular necrosis of femoral head . Patients will undergo core decompression followed by CD133+cell infusion into the cored area. Clinical assessment includes a MRI, Harries Hip Score,SF36, Visual Analogue Scale(VAS), and the WOMAC osteoarthritis Index.
- Conditions
- Osteonecrosis
- Being tested
- CD133+ cells
- Keywords
- Avascular osteonecrosis,CD133+,core decompression
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD133+ cellsBiological
Also called cell injection
bone marrow derived CD133+ cells injection with core compression
| Study group | Role | What they receive |
|---|---|---|
| femoral osteonecrosis patients | Experimental | patientswith femoral head osteonecrosis Receives: Biological: CD133+ cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of bone marrow derived CD133+ cells transplantation
Evaluation safety of bone marrow CD133+ cells transplantation in patients with osteonecrosis of femoral head
Measured: 6 months
Secondary outcomes (3)
improve patient quality of life
evaluate the ability of bone marrow derived CD133+ cells to improve patient quality of life
Measured: 12 months
decrease hip articular change
evaluate the ability of bone marrow derived CD133+ cells to decrease hip articular change
Measured: 24 month
side effects
Evaluate side effects of bone marrow derived CD133+ cells transplantation
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 posted9 Sep 2010 (estimated)
- Study startAug 2009
- Primary completionJun 2013
- Study completionJun 2013
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Head of Royan InstituteAhmad Vosough, MD, Principal investigator, Board scientificNasser Aghdami, MD,PhD, Principal investigator, Head of regenerative medicine centerMohammad Reza Baghban Eslami, PhD, Study director, Board Sientificmohssen Emadeddin, MD, Principal investigator, Orthopedic Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198080
- Sponsor's protocol ID
- Royan-Bone-003
- Status last verified
- Apr 2009
- First submitted
- 8 Sep 2010
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Derived CD133+ Stem Cells Transplantation in Femoral Head Osteonecrosis
- ClinicalTrials.gov ID
- NCT01198080
- Acronym / sponsor ID
- Royan-Bone-003
- Conditions
- Osteonecrosis
- Keywords
- Avascular osteonecrosis,CD133+,core decompression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Aug 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 9 Sep 2010 (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.
Avascular necrosis is a disease where there is cellular death (necrosis) of bone components due to interruption of the blood supply. Without blood, the bone tissue dies and the bone collapses. If avascular necrosis involves the bones of a joint, it often leads to destruction of the joint articular surfaces. Avascular necrosis is especially common in the hip joint. A variety of methods are now used to treat avascular necrosis the most common being the total hip replacement, or THR.A new, more promising treatment is hip resurfacing or metal on metal (MOM) resurfacing.Another treatment is utilization of bone marrow derived stem cells.these stem cells can provide angiogenic factors and osteogenic cytokine to improve angiogenesis and bone formation.
Detailed description
A vascular necrosis of femoral head is a debilitating disease resulting from interruption of blood supply to the bone. This pathologic process results in the death of marrow and osteocytes and, in its final stage, femoral head collapse. The most widespread treatment in the early stage of this disease is core decompression. This surgical procedure involves drilling into the femoral neck through the necrotic area, which reduces pressure within the bone and allows more blood vessels to form. This study is designed to evaluate the clinical safety and efficacy of CD133+ enriched bone marrow infusion adjacent with core decompression in patients with a vascular necrosis of femoral head . Patients will undergo core decompression followed by CD133+cell infusion into the cored area. Clinical assessment includes a MRI, Harries Hip Score,SF36, Visual Analogue Scale(VAS), and the WOMAC osteoarthritis Index.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| femoral osteonecrosis patients | Experimental | Biological: CD133+ cellspatientswith femoral head osteonecrosis |
Who may qualify
- Ages
- 18 to 65 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 |
|---|---|---|
| CD133+ cellsAlso: cell injectionbone marrow derived CD133+ cells injection with core compression | Biological | femoral osteonecrosis patients |
Primary outcome
safety of bone marrow derived CD133+ cells transplantation
Time frame: 6 months
Evaluation safety of bone marrow CD133+ cells transplantation in patients with osteonecrosis of femoral head
3 secondary outcomes
improve patient quality of life
Time frame: 12 months
decrease hip articular change
Time frame: 24 month
side effects
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 28 Aug 2013.
- Related InfoLink provided by the sponsor.
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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.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Ahmad Vosough, MD principal investigator
Board scientific
Nasser Aghdami, MD,PhD principal investigator
Head of regenerative medicine center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD133+ cells in people with Osteonecrosis, run by Royan Institute at 1 site in Iran.
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 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
safety of bone marrow derived CD133+ cells transplantation (time frame: 6 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 28 Aug 2013.