Osteonecrosis of the Femoral HeadPhase 2CSM/ON/2011NCT01700920
PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells
A Phase 2 study testing bone marrow aspirate in people with Osteonecrosis of the Femoral Head, run by Red de Terapia Celular at 1 site in Spain.
Trial summary
The purpose of this study is to analyze the safety and feasibility of direct administration intrafemoral mesenchymal stem cells (MSCs) in vitro expanded autologous treatment of patients with femoral osteonecrosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteonecrosis of the Femoral Head
- What is being tested?
- bone marrow aspirate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2012to Dec 2015
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years
- Clinical diagnosis and imaging (Rx and NMR) of idiopathic osteonecrosis of the femoral head
- Stadiums <IIIC ARCO ranking
Who cannot join
- Those on investigator judgment not in a good position to tolerate the procedure.
- Clinical criteria and anesthetics that contraindicate surgery (eg ASA IV-V)
- Serious illness uncontrolled
- Pregnant women
- Patients with HIV infection +
- Acute infection (in the previous 15 days) or chronic (other than HIV)
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- Previous treatments of osteonecrosis
- Active or previous neoplastic disease (last 5 years) except for patients undergoing allogeneic haematopoietic progenitors who are in complete remission after 2 years after transplantation.
- Lack of informed consent or revocation thereof.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University Hospital of Salamanca
Salamanca, Castille and León, 37007
About this study
The purpose of this study is to analyze the safety and feasibility of direct administration intrafemoral mesenchymal stem cells (MSCs) in vitro expanded autologous treatment of patients with femoral osteonecrosis.
- Conditions
- Osteonecrosis of the Femoral Head
- Being tested
- bone marrow aspirate
- Keywords
- Osteonecrosis of the femoral head, Stem Cell, Mesenchymal Stem Cells, 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.
bone marrow aspirateProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal Stem Cell | Experimental | Cell suspension mesenchymal stem cells (MSCs) obtained from bone marrow aspirate from the patient and expanded in vitro in a specific medium enriched with platelet lysate without addition of animal products.
They employ a minimum dose of 0.5 x 106 MSC / kg and a maximum of 1, 0x106 CSM / kg of patient weight.
Pharmaceutical form: Suspension cell Route of administration: local implant intraosseous injection with trocar in the femoral head. Receives: Procedure: bone marrow aspirate |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteonecrosis 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Red de Terapia Celular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán, Spanish National Health System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700920
- Sponsor's protocol ID
- CSM/ON/2011
- Acronym
- CSM/ON/2011
- Status last verified
- Mar 2017
- First submitted
- 2 Oct 2012
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT01700920
- Acronym / sponsor ID
- CSM/ON/2011 / CSM/ON/2011
- Conditions
- Osteonecrosis of the Femoral Head
- Keywords
- Osteonecrosis of the femoral head, Stem Cell, Mesenchymal Stem Cells, Femoral Head
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Red de Terapia CelularIndustry (pharma, biotech, devices)
- Collaborators
- Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán, Spanish National Health System
- Study start
- Jul 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Oct 2012 (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 analyze the safety and feasibility of direct administration intrafemoral mesenchymal stem cells (MSCs) in vitro expanded autologous treatment of patients with femoral osteonecrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal Stem Cell | Experimental | Procedure: bone marrow aspirateCell suspension mesenchymal stem cells (MSCs) obtained from bone marrow aspirate from the patient and expanded in vitro in a specific medium enriched with platelet lysate without addition of animal products. They employ a minimum dose of 0.5 x 106 MSC / kg and a maximum of 1, 0x106 CSM / kg of patient weight. Pharmaceutical form: Suspension cell Route of administration: local implant intraosseous injection with trocar in the femoral head. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 70 years
- Clinical diagnosis and imaging (Rx and NMR) of idiopathic osteonecrosis of the femoral head
- Stadiums <IIIC ARCO ranking
Key exclusion criteria (9 listed)
- Those on investigator judgment not in a good position to tolerate the procedure.
- Clinical criteria and anesthetics that contraindicate surgery (eg ASA IV-V)
- Serious illness uncontrolled
- Pregnant women
- Patients with HIV infection +
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 |
|---|---|---|
| bone marrow aspirate | Procedure or surgery | Mesenchymal Stem Cell |
Primary outcome
Not reported in the source record.
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 30 Mar 2017.
- Salamanca University FoundationLink provided by the sponsor.
- Spanish Health Institute Carlos IIILink 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bone marrow aspirate in people with Osteonecrosis of the Femoral Head, run by Red de Terapia Celular at 1 site in Spain.
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 9 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 30 Mar 2017. 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 Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 30 Mar 2017.