Avascular Necrosis of Femur HeadPhase 1/2NCT01605383
Mesenchymal Stem Cells in Osteonecrosis of the Femoral Head
A Phase 1/2 study testing XCEL-MT-OSTEO-ALPHA and Standard treatment in people with Avascular Necrosis of Femur Head, run by Banc de Sang i Teixits at 1 site in Spain.
Trial summary
The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head in comparison to the standard treatment of isolated core decompression. XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Avascular Necrosis of Femur Head
- What is being tested?
- XCEL-MT-OSTEO-ALPHA and Standard treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 5 May 2015to 27 Jun 2019
- Phase
- Phase 1/2
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 50 years of age (male and female)
- Osteonecrosis of the hip ARCO grade I or II
- Abscence of systemic or local infection
- Laboratory tests with no relevant abnormal findings that contraindicate the surgery.
- Informed Consent Form signed
- The patient is able to understand the nature of the study
Who cannot join
- Osteonecrosis of the hip secondary to femoral neck fracture
- Patients with no closed cartilage
- Surgical implants in the femoral head
- Septic arthritis
- Patients with severe renal insufficiency
- Patients expecting or with liver transplantation
Show all 15Show fewer
- Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg), Hepatitis C (Anti-HCV-Ab) or Syphilis.
- Pregnant woman or intended to become pregnant, or breath feeding
- Neoplasia within the previous 5 years, or without remission
- Immunosuppressive states
- The patient is legally dependent
- Participation in another clinical trial or treated with an investigational medicinal product the previous 30 days
- Cardiac pacemaker, allergy to contrast or any other condition that contraindicates the MRI with contrast agents
- Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
- The patient does not accept to be followed-up for a period thar could exceed the clinical trial length
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Clinical Trial of "ex Vivo" Expanded Autologous Bone Marrow Mesenchymal Stem Cells Fixed in Allogenic Human Bone Tissue (XCEL-MT-OSTEO- ALPHA) in Osteonecrosis of the Femoral Head
The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head in comparison to the standard treatment of isolated core decompression.
XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue.
The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration, avoiding the progression to collapse of the femoral head.
Read the detailed description
Prospective, open-label with blinded assessor, randomized, parallel, single-dose phase I-II clinical trial in which 24 patients affected with osteonecrosis of the femoral head ARCO grade I or II will enter the trial with the primary objective of assessing the feasibility and safety of "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in osteonecrosis of the femoral head. Secondary objectives are to assess the efficacy of the implantation by imaging (magnetic resonance imaging) and clinical questionnaires (pain by visual analogue scale, quality of life by SF-36 and WOMAC Index).
Patients will be randomized to one of the two treatment arms (core decompression and the tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue or the standard treatment of isolated core decompression). Thereafter, patients will be followed for 12 months.
- Conditions
- Avascular Necrosis of Femur Head
- Being tested
- XCEL-MT-OSTEO-ALPHA, Standard treatment
- Keywords
- Avascular Necrosis of Femur Head, Osteonecrosis of the hip, Osteonecrosis of the femoral head, Mesenchymal Stem Cells, Bone marrow, Tissue engineering, Bone Diseases, Musculoskeletal Diseases
- Medical subject headings
- Femur Head Necrosis, Legg-Calve-Perthes Disease, Bone Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XCEL-MT-OSTEO-ALPHABiological
Core decompression plus XCEL-MT-OSTEO-ALPHA
Standard treatmentProcedure or surgery
Isolated core decompression
| Study group | Role | What they receive |
|---|---|---|
| XCEL-MT-OSTEO-ALPHA | Experimental | "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue (under Xcelia-GMP conditions)for osteonecrosis of the femoral head Receives: Biological: XCEL-MT-OSTEO-ALPHA |
| Standard Treatment | Sham comparator | Isolated core decompression Receives: Procedure: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head
Safety will be assessed by collecting adverse events throughout the experimental phase, which includes a follow-up of 12 months
Measured: 12 months
Feasibility of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head
Feasibility will be measured by assessing the percentage of patients to which bone marrow puncture is made are thereafter treated and by checking the cascade of procedures to confirm the global process is viable.
Measured: 12 months
Secondary outcomes (5)
Bone regeneration by measuring the necrotic angle using the modified Kerboul method
The necrotic angle will be measured using imaging procedures (magnetic resonance imaging MRI).
Measured: 6 and 12 months
Dynamic changes of signal intensity
Dynamic changes of signal intensity after Gd enhancement in the necrotic areas of the femoral head
Measured: 6 and 12 months
Clinical outcomes (pain) by Visual Analogue Scale (VAS)
Pain measurement by VAS
Measured: 7 days and at 3, 6 and 12 months
Clinical outcomes (SF-36)
This clinical outcome will measure the quality of life by the self-reported quality of life questionnaire SF-36
Measured: 3, 6 and 12 months
Clinical outcome (WOMAC)
To assess the extent by which a person's functional level is restricted by the WOMAC index
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study start5 May 2015
- Primary completion11 Apr 2018
- Study completion27 Jun 2019
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 Femur 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banc de Sang i Teixits
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Sanidad, Servicios Sociales e Igualdad, Ministerio de Ciencia e Innovación, Spain, European Regional Development Fund
- Responsible party
- Sponsor
- Investigators
- Màrius Aguirre, MD, PhD, Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605383
- Sponsor's protocol ID
- XCEL-MT-10-01
- Other IDs
- 2010-023998-18
- Status last verified
- Jan 2020
- First submitted
- 22 May 2012
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Vives J, Oliver-Vila I, Pla A. Quality compliance in the shift from cell transplantation to cell therapy in non-pharma environments. Cytotherapy. 2015 Aug;17(8):1009-14. doi: 10.1016/j.jcyt.2015.02.002. Epub 2015 Mar 10.
PubMed 25769789
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial of "ex Vivo" Expanded Autologous Bone Marrow Mesenchymal Stem Cells Fixed in Allogenic Human Bone Tissue (XCEL-MT-OSTEO- ALPHA) in Osteonecrosis of the Femoral Head
- ClinicalTrials.gov ID
- NCT01605383
- Acronym / sponsor ID
- XCEL-MT-10-01
- Conditions
- Avascular Necrosis of Femur Head
- Keywords
- Avascular Necrosis of Femur Head, Osteonecrosis of the hip, Osteonecrosis of the femoral head, Mesenchymal Stem Cells, Bone marrow, Tissue engineering, Bone Diseases, Musculoskeletal Diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Banc de Sang i TeixitsUniversity, hospital or other
- Collaborators
- Ministerio de Sanidad, Servicios Sociales e Igualdad, Ministerio de Ciencia e Innovación, Spain, European Regional Development Fund
- Study start
- 5 May 2015 (actual)
- Primary completion
- 11 Apr 2018 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 24 May 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 present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head in comparison to the standard treatment of isolated core decompression.
XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue.
The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration, avoiding the progression to collapse of the femoral head.
Detailed description
Prospective, open-label with blinded assessor, randomized, parallel, single-dose phase I-II clinical trial in which 24 patients affected with osteonecrosis of the femoral head ARCO grade I or II will enter the trial with the primary objective of assessing the feasibility and safety of "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in osteonecrosis of the femoral head. Secondary objectives are to assess the efficacy of the implantation by imaging (magnetic resonance imaging) and clinical questionnaires (pain by visual analogue scale, quality of life by SF-36 and WOMAC Index).
Patients will be randomized to one of the two treatment arms (core decompression and the tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue or the standard treatment of isolated core decompression). Thereafter, patients will be followed for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XCEL-MT-OSTEO-ALPHA | Experimental | Biological: XCEL-MT-OSTEO-ALPHA"ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue (under Xcelia-GMP conditions)for osteonecrosis of the femoral head |
| Standard Treatment | Sham comparator | Procedure: Standard treatmentIsolated core decompression |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18 to 50 years of age (male and female)
- Osteonecrosis of the hip ARCO grade I or II
- Abscence of systemic or local infection
- Laboratory tests with no relevant abnormal findings that contraindicate the surgery.
- Informed Consent Form signed
Key exclusion criteria (15 listed)
- Osteonecrosis of the hip secondary to femoral neck fracture
- Patients with no closed cartilage
- Surgical implants in the femoral head
- Septic arthritis
- Patients with severe renal insufficiency
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 |
|---|---|---|
| XCEL-MT-OSTEO-ALPHACore decompression plus XCEL-MT-OSTEO-ALPHA | Biological | XCEL-MT-OSTEO-ALPHA |
| Standard treatmentIsolated core decompression | Procedure or surgery | Standard Treatment |
Primary outcome
Safety of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head
Time frame: 12 months
Safety will be assessed by collecting adverse events throughout the experimental phase, which includes a follow-up of 12 months
Feasibility of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head
Time frame: 12 months
Feasibility will be measured by assessing the percentage of patients to which bone marrow puncture is made are thereafter treated and by checking the cascade of procedures to confirm the global process is viable.
5 secondary outcomes
Bone regeneration by measuring the necrotic angle using the modified Kerboul method
Time frame: 6 and 12 months
Dynamic changes of signal intensity
Time frame: 6 and 12 months
Clinical outcomes (pain) by Visual Analogue Scale (VAS)
Time frame: 7 days and at 3, 6 and 12 months
Clinical outcomes (SF-36)
Time frame: 3, 6 and 12 months
Clinical outcome (WOMAC)
Time frame: 3, 6 and 12 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 Jan 2020.
- Derived from this study: PubMed 25769789Vives J, Oliver-Vila I, Pla A. Quality compliance in the shift from cell transplantation to cell therapy in non-pharma environments. Cytotherapy. 2015 Aug;17(8):1009-14. doi: 10.1016/j.jcyt.2015.02.002. Epub 2015 Mar 10.
- Banc de Sang i Teixits. Xcelia-División de Terapias Avanzadas.Link provided by the sponsor.
- Hospital Universitari Vall d'Hebron, BarcelonaLink 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.
Màrius Aguirre, MD, PhD principal investigator
Hospital Vall d'Hebron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing XCEL-MT-OSTEO-ALPHA and Standard treatment in people with Avascular Necrosis of Femur Head, run by Banc de Sang i Teixits 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 6 inclusion and 15 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 Jan 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
Safety of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT01605383, 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 21 Jan 2020.