Lumbar Spondylolisthesis Involving L4-L5, and/orPhase 1/2NCT01552707
Safety Study of Mesenchymal Stem Cells and Spinal Fusion
A Phase 1/2 study testing XCEL-MT-OSTEO-ALPHA and Standard treatment in people with Lumbar Spondylolisthesis Involving L4-L5, and/or and Degenerative Discopathy Involving L4-L5, run by Banc de Sang i Teixits at 5 sites in Spain.
Trial summary
The present prospective, randomized study, compares the spinal fusion obtained after instrumentation and the use of a biologic product (patient's mesenchymal cells obtained from his/her own bone marrow which will be fixed in human bone tissue form a donor), with the current procedure that consists in instrumented… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lumbar Spondylolisthesis Involving L4-L5, and/or, Degenerative Discopathy Involving L4-L5
- 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
- 69 participants
- Where
- 5 sitesSpain
- Study dates
- 19 Jul 2012to 21 Oct 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- L4-L5 degenerative spondylolisthesis grade I-II Meyerding isolated or associated to more than one level, and/or L4-L5 degenerative discopathy isolated or associated to more than one level.
- 18 to 85 years of age (male and female)
- Informed Consent Form signed
- The patient is able to understand the nature of the study
Who cannot join
- Previous spine surgery
- L4 isthmic spondylolisthesis
- Smoker (more than 10 cigarettes a day)
- Systemic or local infection
- Patients treated with steroids (oral or systemic) within 3 months of entering the study, or treated with biphosphonates for more than 10 years
- Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg), Hepatitis C (Anti-HCV-Ab) or Syphilis.
Show all 14Show fewer
- Pregnant woman or intended to become pregnant, or breath feeding
- Neoplasia within the previous 5 years, or without remission
- Immunosuppressive states (except diabetes mellitus. Treatment with therapies is allowed)
- Significant abnormal laboratory tests that contraindicates the surgery.
- Participation in another clinical trial or treated with an investigational medicinal product the previous 3 months
- 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 that could exceed the clinical trial length
- The patient is legally dependent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Parc de Salut Mar
Barcelona, 08003
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Institut Universitari Dexeus (ICATME)
Barcelona, 08028
Hospital Vall d'Hebron
Barcelona, 08035
About this study
Official title: "Ex Vivo" Expanded Autologous Bone Marrow Mesenchymal Stem Cells Fixed in Allogenic Human Bone Tissue for Spinal Fusion in Spine Degenerative Disease
The present prospective, randomized study, compares the spinal fusion obtained after instrumentation and the use of a biologic product (patient's mesenchymal cells obtained from his/her own bone marrow which will be fixed in human bone tissue form a donor), with the current procedure that consists in instrumented spinal fusion and the use of each patient's bone obtained from his/her iliac crest.
The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration, avoiding the need for obtaining patient's iliac crest and its associated morbidity.
Read the detailed description
Prospective, open-label, randomized, parallel, single-dose phase I-II clinical trial in which 62 patients affected with L4-L5 degenerative spondylolisthesis grade I-II according to Meyerding and/or with L4-L5 degenerative discopathy needing spinal fusion 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 spinal fusion. Secondary objectives are to assess the efficacy of the implantation by imaging (computerized helicoidal tomography and X-ray) and clinical questionnaires (pain by visual analogue scale, quality of life by SF-36 and Oswestry Disability Index).
Patients will be randomized to one of the two treatment arms (instrumented spinal fusion and the tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion or the standard treatment of instrumented spinal fusion and patient's bone iliac crest). Thereafter, patients will be followed for 12 months.
Imaging assessment will be done by an independent blinded radiologist.
- Being tested
- XCEL-MT-OSTEO-ALPHA, Standard treatment
- Keywords
- Spondylolisthesis, Degenerative discopathy, Mesenchymal Stem Cells, Bone marrow, Tissue engineering, Spinal fusion
- Medical subject headings
- Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XCEL-MT-OSTEO-ALPHABiological
Isolation and "ex-vivo" expansion of mesenchymal stem cells (MSC) obtained from each patient's bone marrow under GMP conditions at Xcelia, División de Terapias Avanzadas delBanc de Sang i Teixits. After expansion, MSCs are fixed in allogenic bone tissue and implanted in instrumented spinal fusion.
Standard treatmentProcedure or surgery
Instrumented spinal fusion together with patient's bone iliac crest
| Study group | Role | What they receive |
|---|---|---|
| XCEL-MT-OSTEO-ALPHA | Experimental | "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue for spinal fusion Receives: Biological: XCEL-MT-OSTEO-ALPHA |
| Standard treatment | Sham comparator | Instrumented spinal fusion together with patient's bone iliac crest. 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 (tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion)
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 (composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion)
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)
Efficacy spinal fusion by imaging procedures (X-Ray).
Spinal fusion will be assessed by spinal X-Ray
Measured: 3, 6 and 12 months
Efficacy spinal fusion by imaging procedures (computerized helicoidal tomography)
Spinal fusion will be assessed by the presence of solid bonny bridges using computerized helicoidal tomography.
Measured: 6 and 12 months
Clinical outcomes (VAS)
Pain measurement by visual analogue scale (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 (Oswestry Disability Index)
To assess the extent by which a person's functional level is restricted by disability by the Oswestry Disability 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 posted13 Mar 2012 (estimated)
- Study start19 Jul 2012
- Primary completion3 May 2018
- Study completion21 Oct 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 Lumbar Spondylolisthesis Involving L4-L5, and/orStudies 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banc de Sang i Teixits
- Sponsor type
- University, hospital or other
- Collaborators
- TFS Trial Form Support, Ministerio de Sanidad, Servicios Sociales e Igualdad, Ministerio de Ciencia e Innovación, Spain
- Responsible party
- Sponsor
- Investigators
- Joan Bagó, MD, PhD, Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552707
- Sponsor's protocol ID
- XCEL-MT-10-02
- Status last verified
- Jan 2020
- First submitted
- 8 Mar 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
- "Ex Vivo" Expanded Autologous Bone Marrow Mesenchymal Stem Cells Fixed in Allogenic Human Bone Tissue for Spinal Fusion in Spine Degenerative Disease
- ClinicalTrials.gov ID
- NCT01552707
- Acronym / sponsor ID
- XCEL-MT-10-02
- Keywords
- Spondylolisthesis, Degenerative discopathy, Mesenchymal Stem Cells, Bone marrow, Tissue engineering, Spinal fusion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Banc de Sang i TeixitsUniversity, hospital or other
- Collaborators
- TFS Trial Form Support, Ministerio de Sanidad, Servicios Sociales e Igualdad, Ministerio de Ciencia e Innovación, Spain
- Study start
- 19 Jul 2012 (actual)
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 21 Oct 2019 (actual)
- First posted
- 13 Mar 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 prospective, randomized study, compares the spinal fusion obtained after instrumentation and the use of a biologic product (patient's mesenchymal cells obtained from his/her own bone marrow which will be fixed in human bone tissue form a donor), with the current procedure that consists in instrumented spinal fusion and the use of each patient's bone obtained from his/her iliac crest.
The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration, avoiding the need for obtaining patient's iliac crest and its associated morbidity.
Detailed description
Prospective, open-label, randomized, parallel, single-dose phase I-II clinical trial in which 62 patients affected with L4-L5 degenerative spondylolisthesis grade I-II according to Meyerding and/or with L4-L5 degenerative discopathy needing spinal fusion 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 spinal fusion. Secondary objectives are to assess the efficacy of the implantation by imaging (computerized helicoidal tomography and X-ray) and clinical questionnaires (pain by visual analogue scale, quality of life by SF-36 and Oswestry Disability Index).
Patients will be randomized to one of the two treatment arms (instrumented spinal fusion and the tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion or the standard treatment of instrumented spinal fusion and patient's bone iliac crest). Thereafter, patients will be followed for 12 months.
Imaging assessment will be done by an independent blinded radiologist.
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 for spinal fusion |
| Standard treatment | Sham comparator | Procedure: Standard treatmentInstrumented spinal fusion together with patient's bone iliac crest. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- L4-L5 degenerative spondylolisthesis grade I-II Meyerding isolated or associated to more than one level, and/or L4-L5 degenerative discopathy isolated or associated to more than one level.
- 18 to 85 years of age (male and female)
- Informed Consent Form signed
- The patient is able to understand the nature of the study
Key exclusion criteria (14 listed)
- Previous spine surgery
- L4 isthmic spondylolisthesis
- Smoker (more than 10 cigarettes a day)
- Systemic or local infection
- Patients treated with steroids (oral or systemic) within 3 months of entering the study, or treated with biphosphonates for more than 10 years
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-ALPHAIsolation and "ex-vivo" expansion of mesenchymal stem cells (MSC) obtained from each patient's bone marrow under GMP conditions at Xcelia, División de Terapias Avanzadas delBanc de Sang i Teixits. After expansion, MSCs are fixed in allogenic bone tissue and implanted in instrumented spinal fusion. | Biological | XCEL-MT-OSTEO-ALPHA |
| Standard treatmentInstrumented spinal fusion together with patient's bone iliac crest | Procedure or surgery | Standard treatment |
Primary outcome
safety of XCEL-MT-OSTEO-ALPHA (tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion)
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 (composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion)
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
Efficacy spinal fusion by imaging procedures (X-Ray).
Time frame: 3, 6 and 12 months
Efficacy spinal fusion by imaging procedures (computerized helicoidal tomography)
Time frame: 6 and 12 months
Clinical outcomes (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 (Oswestry Disability Index)
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.
- Institut Català de Traumatologia i Medicina de l'Esport (Institut Universitari Dexeus)Link provided by the sponsor.
- Hospital Universitari Vall d'Hebron, BarcelonaLink provided by the sponsor.
- Hospital Universitari Germans Trias i Pujol, BadalonaLink provided by the sponsor.
- Hospital Parc de Salut Mar, BarcelonaLink provided by the sponsor.
- Hospital de la Santa Creu i Sant Pau, BarcelonaLink provided by the sponsor.
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.
Joan Bagó, MD, PhD principal investigator
Hospital Vall d'Hebron
5 sites 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 Lumbar Spondylolisthesis Involving L4-L5, and/or and Degenerative Discopathy Involving L4-L5, run by Banc de Sang i Teixits at 5 sites 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 4 inclusion and 14 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 5 sites 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 (tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion) (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 NCT01552707, 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.