Osteochondritis of the Femoral HeadEarly Phase 1NCT00813267
Mesenchymal Stem Cell for Osteonecrosis of the Femoral Head
A Early Phase 1 study testing mesenchymal stem cell infusion and bone marrow mononuclear cell infusion in people with Osteochondritis of the Femoral Head, run by Jianming Tan at 1 site in China.
Trial summary
Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and complimentary effects to MSCs. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Osteochondritis of the Femoral Head
- What is being tested?
- mesenchymal stem cell infusion and bone marrow mononuclear cell infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to Aug 2015
- Phase
- Early 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages: 12 to 60 years old.
- Association Research Circulation Osseous(ARCO) Classification criteria for osteonecrosis of the femoral head: ARCO phase I and phase II.
- Able to give informed consent.
Who cannot join
- Pregnant women.
- Previous history of malignancy
- Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.
- Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in the past 6 months.
- Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible.
- Any illness that in the opinion of the investigator would jeopardize the ability of the Patient to tolerate this treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mesenchymal Stem Cell Transplantation in the Treatment of Osteonecrosis of the Femoral Head
Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and complimentary effects to MSCs. The investigators will infuse expanded autologous MSCs and BMMNCs into patients with osteonecrosis of the femoral head. The study purpose is to examine whether this treatment will result in improvement in osteonecrosis of the femoral head.
Read the detailed description
Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and complimentary effects to MSCs. Patients in this study will receive infusion of expanded autologous MSC and BMMNCs. The puncture of femoral artery will be conducted with digital subtraction angiography(DSA), and the tubes will be inserted into medial femoral circumflex artery,lateral femoral circumflex artery and obturatou artey. The study will evaluate the safety and effectiveness of MSC infusion in patients with osteonecrosis of the femoral head. This study will last for 5 years. Patients will undergo infusions at Day 0. Afterward, patients will be evaluated for response, and undergo X-ray examination, CT and MR scanning at a 6-month interval.
- Conditions
- Osteochondritis of the Femoral Head
- Being tested
- mesenchymal stem cell infusion, bone marrow mononuclear cell infusion
- Keywords
- Mesenchymal Stem Cells, Osteonecrosis of the Femoral Head
- Medical subject headings
- Legg-Calve-Perthes Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal stem cell infusionBiological
Also called MSC infusion
bone marrow mononuclear cell infusionBiological
Also called BMMNC infusion
| Study group | Role | What they receive |
|---|---|---|
| stem cell | Experimental | mesenchymal stem cell infusion and bone marrow mononuclear cell infusion Receives: Biological: mesenchymal stem cell infusion; Biological: bone marrow mononuclear cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The femoral head blood-supply artery angiographies and the areas of femoral head necrosis
Measured: 2
Secondary outcomes (4)
Coxa joint paining
Measured: 2
Walking distance
Measured: 2
Joint functions
Measured: 2
Life
Measured: 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startDec 2009
- Primary completionAug 2011
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondritis of the Femoral HeadStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jianming Tan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianming Tan, Fuzhou General Hospital
- Investigators
- Jianming Tan, professor, Principal investigator, Fuzhou General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813267
- Sponsor's protocol ID
- fuzhough1221
- Status last verified
- Oct 2012
- First submitted
- 21 Dec 2008
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stem Cell Transplantation in the Treatment of Osteonecrosis of the Femoral Head
- ClinicalTrials.gov ID
- NCT00813267
- Acronym / sponsor ID
- fuzhough1221
- Conditions
- Osteochondritis of the Femoral Head
- Keywords
- Mesenchymal Stem Cells, Osteonecrosis of the Femoral Head
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Jianming TanUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2015 (estimated)
- First posted
- 23 Dec 2008 (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.
Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and complimentary effects to MSCs. The investigators will infuse expanded autologous MSCs and BMMNCs into patients with osteonecrosis of the femoral head. The study purpose is to examine whether this treatment will result in improvement in osteonecrosis of the femoral head.
Detailed description
Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and complimentary effects to MSCs. Patients in this study will receive infusion of expanded autologous MSC and BMMNCs. The puncture of femoral artery will be conducted with digital subtraction angiography(DSA), and the tubes will be inserted into medial femoral circumflex artery,lateral femoral circumflex artery and obturatou artey. The study will evaluate the safety and effectiveness of MSC infusion in patients with osteonecrosis of the femoral head. This study will last for 5 years. Patients will undergo infusions at Day 0. Afterward, patients will be evaluated for response, and undergo X-ray examination, CT and MR scanning at a 6-month interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stem cell | Experimental | Biological: mesenchymal stem cell infusion, Biological: bone marrow mononuclear cell infusionmesenchymal stem cell infusion and bone marrow mononuclear cell infusion |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Ages: 12 to 60 years old.
- Association Research Circulation Osseous(ARCO) Classification criteria for osteonecrosis of the femoral head: ARCO phase I and phase II.
- Able to give informed consent.
Key exclusion criteria (6 listed)
- Pregnant women.
- Previous history of malignancy
- Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.
- Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in the past 6 months.
- Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible.
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 |
|---|---|---|
| mesenchymal stem cell infusionAlso: MSC infusion | Biological | stem cell |
| bone marrow mononuclear cell infusionAlso: BMMNC infusion | Biological | stem cell |
Primary outcome
The femoral head blood-supply artery angiographies and the areas of femoral head necrosis
Time frame: 2
4 secondary outcomes
Coxa joint paining
Time frame: 2
Walking distance
Time frame: 2
Joint functions
Time frame: 2
Life
Time frame: 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
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.
Jianming Tan, professor principal investigator
Fuzhou General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing mesenchymal stem cell infusion and bone marrow mononuclear cell infusion in people with Osteochondritis of the Femoral Head, run by Jianming Tan at 1 site in China.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Oct 2012. 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 China. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 femoral head blood-supply artery angiographies and the areas of femoral head necrosis (time frame: 2). 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 10 Oct 2012.