Avascular Necrosis of the Femoral HeadPhase 2ORTHO-2NCT02065167
Evaluation of Mesenchymal Stem Cells to Treat Avascular Necrosis of the Hip
A Phase 2 study testing Cultured autologous Mesenchymal Cells in people with Avascular Necrosis of the Femoral Head, run by Universidad Autonoma de Madrid at 6 sites in 4 countries.
Trial summary
The purpose is to assess the safety and feasibility of cellular therapy derived from bone marrow, to help bone healing in patients with avascular necrosis of the hip. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Avascular Necrosis of the Femoral Head
- What is being tested?
- Cultured autologous Mesenchymal Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Feb 2014to Dec 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65, both sexes
- Early avascular necrosis of the fem oral head (MRI diagnosis): Ficat and Arlet 0, 1, or 2 (Steinberg stages 0, I, IIA, IIB, or IIC)
- Sym ptom atic osteonecrosis with less than 6 months of evolution
- Able to provide informed consent, and signed informed consent
- Medical health care coverage
Who cannot join
- Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control.
- Participation in another therapeutic trial in the previous 3 m onths
- Stages 3 or m ore (Ficat and Arlet) or III or m ore (Steinberg) of severe fem oral head osteonecrosis,primarily based on diagnosis by im aging (X-Rays, MRI).
- Flattening or collapse of the fem oral head (Steinberg stage IV) or articular cartilage collapse at the time of core decompression surgery.
- Septic arthritis.
- Stress fracture.
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- Non-osteonecrosis metabolic bone diseases (particularly 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.
- History of prior or concurrent diagnosis of HIV-, Hepatitis-B- or Hepatitis-C-infection
- Active hepatitis B or hepatitis C infection at the time of screening.
- Known allergies to products involved in the production process of MSC.
- History of neoplasia or current neoplasia in any organ.
- Corticoid or immunosuppressive therapy more than one week in the two months prior to study inclusion
- Patients who will require continuous, systemic, high dose corticosteroid therapy (more than 7.5 m g/day) within 6 months after surgery.
- Patients who are in active treatment for cancer or blood dyscrasia, or have received chemotherapy, radiotherapy or immunotherapy in the past 2 years.
- History of regular alcohol consumption exceeding 2 drinks/day within 6 months of screening and/or history of illicit drug use.
- Serum AST (SGO T)/ALT (SGPT) > 2.5 X (institutional standard range).
- MRI-incompatible internal devices (pacemakers, aneurysm clips, etc).
- Body mass index (BMI) of 40 kg/m ² or greater.
- Patients unable to tolerate general anesthesia defined as an American Society of Anesthesiologists (ASA) criteria of > 2.
- Insulin dependent diabetes
- 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 antiangiogenesis treatment.
- Traumatic osteonecrosis.
- Adult in the care of a guardian (Subject legally protected)
- Im possibility to meet at the appointments for the clinical follow up.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
France2 sites
Department of Orthopaedic Surgery, Hôpital Henri Mondor
Créteil, 94000
Department of Orthopaedic Surgery, CHU Tours
Tours, 37044
Germany2 sites
University Children's Hospital
Tübingen, 72076
Department of Orthopaedic Trauma, University of Ulm
Ulm, 8907581
Spain1 site
Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz
Madrid, 28046
About this study
Official title: Evaluation of Safety and Feasibility of Bone Marrow Derived Autologous MSCs to Enhance Bone Healing in Patients With Avascular Necrosis of the Femoral Head
The purpose is to assess the safety and feasibility of cellular therapy derived from bone marrow, to help bone healing in patients with avascular necrosis of the hip.
Read the detailed description
To assess the safety and feasibility of an in situ single injection of a high dose of autologous bone marrow-derived, in vitro expanded Mesenchymal stem cells, and its contribution to the resolution of the early stages of avascular osteonecrosis of the femoral head.
- Conditions
- Avascular Necrosis of the Femoral Head
- Being tested
- Cultured autologous Mesenchymal Cells
- Keywords
- avascular necrosis of femoral head, cell therapy, Mesenchymal stem cells
- Medical subject headings
- Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultured autologous Mesenchymal CellsBiological
Cultured Mesenchymal Cells from bone marrow isolation, expanded under GMP protocol in associated facilities and introduced at the end of the appropriate forage up to the femoral head under fluoroscopic control.
| Study group | Role | What they receive |
|---|---|---|
| Cultured autologous Mesenchymal Cells | Experimental | Cultured Mesenchymal Cells from bone marrow isolation, expanded under GMP protocol in associated facilities and introduced at the end of the appropriate forage up to the femoral head under fluoroscopic control.
20x106 cells per cc in a single administration of 7cc Receives: Biological: Cultured autologous Mesenchymal Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
Includes early local complication rate plus global complication rate, as the percentage of patients with local or general complications at 52 weeks.
Measured: 12 months
Secondary outcomes (5)
complication rate
Local and general complication rate
Measured: 6,12,24,104 weeks
Progression of disease to the next stage
Measured: 12 months
Amount of necrotic bone in the femoral head in MRI
Measured: 12 weeks and 52 weeks
Pain (VAS)
Measured: 6,12,24,52,104 weeks
serum levels of bone turnover markers
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Avascular Necrosis 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Enrique Gomez-Barrena, Universidad Autonoma de Madrid
- Investigators
- Enrique Gomez-Barrena, Prof, Study chair, Universidad Autonoma de Madrid, Hospital la Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065167
- Sponsor's protocol ID
- ORTHO -2
- Other IDs
- 2012-002010-39
- Acronym
- ORTHO-2
- Status last verified
- Oct 2021
- First submitted
- 12 Feb 2014
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gomez-Barrena E, Padilla-Eguiluz NG, Rosset P, Hernigou P, Baldini N, Ciapetti G, Gonzalo-Daganzo RM, Avendano-Sola C, Rouard H, Giordano R, Dominici M, Schrezenmeier H, Layrolle P, On Behalf Of The Reborne Consortium. Osteonecrosis of the Femoral Head Safely Healed with Autologous, Expanded, Bone Marrow-Derived Mesenchymal Stromal Cells in a Multicentric Trial with Minimum 5 Years Follow-Up. J Clin Med. 2021 Feb 1;10(3):508. doi: 10.3390/jcm10030508.
PubMed 33535589
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Feasibility of Bone Marrow Derived Autologous MSCs to Enhance Bone Healing in Patients With Avascular Necrosis of the Femoral Head
- ClinicalTrials.gov ID
- NCT02065167
- Acronym / sponsor ID
- ORTHO-2 / ORTHO -2
- Conditions
- Avascular Necrosis of the Femoral Head
- Keywords
- avascular necrosis of femoral head, cell therapy, Mesenchymal stem cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 17 Feb 2014 (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 is to assess the safety and feasibility of cellular therapy derived from bone marrow, to help bone healing in patients with avascular necrosis of the hip.
Detailed description
To assess the safety and feasibility of an in situ single injection of a high dose of autologous bone marrow-derived, in vitro expanded Mesenchymal stem cells, and its contribution to the resolution of the early stages of avascular osteonecrosis of the femoral head.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cultured autologous Mesenchymal Cells | Experimental | Biological: Cultured autologous Mesenchymal CellsCultured Mesenchymal Cells from bone marrow isolation, expanded under GMP protocol in associated facilities and introduced at the end of the appropriate forage up to the femoral head under fluoroscopic control. 20x106 cells per cc in a single administration of 7cc |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 65, both sexes
- Early avascular necrosis of the fem oral head (MRI diagnosis): Ficat and Arlet 0, 1, or 2 (Steinberg stages 0, I, IIA, IIB, or IIC)
- Sym ptom atic osteonecrosis with less than 6 months of evolution
- Able to provide informed consent, and signed informed consent
- Medical health care coverage
Key exclusion criteria (26 listed)
- Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control.
- Participation in another therapeutic trial in the previous 3 m onths
- Stages 3 or m ore (Ficat and Arlet) or III or m ore (Steinberg) of severe fem oral head osteonecrosis,primarily based on diagnosis by im aging (X-Rays, MRI).
- Flattening or collapse of the fem oral head (Steinberg stage IV) or articular cartilage collapse at the time of core decompression surgery.
- Septic arthritis.
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 |
|---|---|---|
| Cultured autologous Mesenchymal CellsCultured Mesenchymal Cells from bone marrow isolation, expanded under GMP protocol in associated facilities and introduced at the end of the appropriate forage up to the femoral head under fluoroscopic control. | Biological | Cultured autologous Mesenchymal Cells |
Primary outcome
Complication rate
Time frame: 12 months
Includes early local complication rate plus global complication rate, as the percentage of patients with local or general complications at 52 weeks.
5 secondary outcomes
complication rate
Time frame: 6,12,24,104 weeks
Progression of disease to the next stage
Time frame: 12 months
Amount of necrotic bone in the femoral head in MRI
Time frame: 12 weeks and 52 weeks
Pain (VAS)
Time frame: 6,12,24,52,104 weeks
serum levels of bone turnover markers
Time frame: 12 and 24 weeks
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 14 Oct 2021.
- Results publication: PubMed 33535589Gomez-Barrena E, Padilla-Eguiluz NG, Rosset P, Hernigou P, Baldini N, Ciapetti G, Gonzalo-Daganzo RM, Avendano-Sola C, Rouard H, Giordano R, Dominici M, Schrezenmeier H, Layrolle P, On Behalf Of The Reborne Consortium. Osteonecrosis of the Femoral Head Safely Healed with Autologous, Expanded, Bone Marrow-Derived Mesenchymal Stromal Cells in a Multicentric Trial with Minimum 5 Years Follow-Up. J Clin Med. 2021 Feb 1;10(3):508. doi: 10.3390/jcm10030508.
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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.
Enrique Gomez-Barrena, Prof study chair
Universidad Autonoma de Madrid, Hospital la Paz
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cultured autologous Mesenchymal Cells in people with Avascular Necrosis of the Femoral Head, run by Universidad Autonoma de Madrid at 6 sites in 4 countries.
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 5 inclusion and 26 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 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Germany, Italy, 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.
What does the primary outcome measure?
Complication rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02065167, which also lists 1 linked publication.
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 14 Oct 2021.