Intervertebral Disc DiseasePhase 1/2NCT01513694
Clinical Trial Based on the Use of Mesenchymal Stem Cells From Autologous Bone Marrow in Patients With Lumbar Intervertebral Degenerative Disc Disease
A Phase 1/2 study testing Instrumented posterolateral arthrodesis in people with Intervertebral Disc Disease, run by Red de Terapia Celular at 1 site in Spain.
Trial summary
The purpose of this trial is to test the effectiveness of the use of a new therapeutic strategy in treating patients with degenerative disc disease lumbar intervertebral fusion with instrumented posterolateral autologous mesenchymal stem cells and arranged in a calcium phosphate ceramic (Conduit TM). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intervertebral Disc Disease
- What is being tested?
- Instrumented posterolateral arthrodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2010to 4 May 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical
- Box symptomatic (back pain and / or root) of lumbar degenerative disc disease monosegmental.
- Discopathy refractory to conservative treatment (drugs, physical therapy.)
- Evolution greater than or equal to 6 months. Radiological
- Discopathy radiation. Disc space narrowing, osteophytes, abnormal mobility, etc
- NMR: grades IV and V of Pfirman.
Who cannot join
- Rejection of surgical treatment.
- Systemic inflammatory disease (spondylitis, rheumatoid arthritis etc), tumor or infection.
- Immunosuppressive treatment.
- Congenital or acquired anatomical abnormality that prevents the surgical procedure.
- Neuropsychiatric pathology, drug addiction, psychosis, severe personality disorder.
- High surgical risk (ASA> IV), or contraindication to anesthesia.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Trauma Service. Hospital Universitario de Salamanca
Salamanca, Castille and León, 37007
About this study
Official title: Clinical Trial Phase I / II Prospective, Open, Non-randomized for Treatment of Lumbar Intervertebral Degenerative Disc Disease With Posterolateral Instrumented and Autologous Mesenchymal Stem Cells.
The purpose of this trial is to test the effectiveness of the use of a new therapeutic strategy in treating patients with degenerative disc disease lumbar intervertebral fusion with instrumented posterolateral autologous mesenchymal stem cells and arranged in a calcium phosphate ceramic (Conduit TM).
- Conditions
- Intervertebral Disc Disease
- Being tested
- Instrumented posterolateral arthrodesis
- Keywords
- Mesenchymal Stem Cells, Stem Cells, Intervertebral disc disease
- Medical subject headings
- Intervertebral disc disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrumented posterolateral arthrodesisProcedure or surgery
Cell suspension of 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 used a minimum dose of 0.5 x106 CSM / kg and a maximum of 1, 5x106 CSM / kg of patient weight.
Dosage Form: Suspension cell support hydroxyapatite and calcium phosphate Route of administration: placement in the fusion bed during surgery.
| Study group | Role | What they receive |
|---|---|---|
| MSC seeded onto a phosphate ceramic | Experimental | Instrumented posterolateral fusion and autologous mesenchymal stem cells arranged in a phosphate ceramic. Receives: Procedure: Instrumented posterolateral arthrodesis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startJan 2010
- Primary completion4 May 2017
- Study completion4 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intervertebral Disc DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
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
- NCT01513694
- Sponsor's protocol ID
- CSM/Fusión/2009
- Status last verified
- May 2017
- First submitted
- 16 Jan 2012
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gomez-Ruiz V, Blanco JF, Villaron EM, Fidalgo H, Lopez-Parra M, Sanchez-Guijo F. Autologous mesenchymal stem cell transplantation for spinal fusion: 10 years follow-up of a phase I/II clinical trial. Stem Cell Res Ther. 2023 Apr 11;14(1):78. doi: 10.1186/s13287-023-03298-4.
PubMed 37038216Blanco JF, Villaron EM, Pescador D, da Casa C, Gomez V, Redondo AM, Lopez-Villar O, Lopez-Parra M, Muntion S, Sanchez-Guijo F. Autologous mesenchymal stromal cells embedded in tricalcium phosphate for posterolateral spinal fusion: results of a prospective phase I/II clinical trial with long-term follow-up. Stem Cell Res Ther. 2019 Feb 22;10(1):63. doi: 10.1186/s13287-019-1166-4.
PubMed 30795797
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Phase I / II Prospective, Open, Non-randomized for Treatment of Lumbar Intervertebral Degenerative Disc Disease With Posterolateral Instrumented and Autologous Mesenchymal Stem Cells.
- ClinicalTrials.gov ID
- NCT01513694
- Acronym / sponsor ID
- CSM/Fusión/2009
- Conditions
- Intervertebral Disc Disease
- Keywords
- Mesenchymal Stem Cells, Stem Cells, Intervertebral disc disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- 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
- Jan 2010
- Primary completion
- 4 May 2017 (actual)
- Study completion
- 4 May 2017 (actual)
- First posted
- 20 Jan 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 trial is to test the effectiveness of the use of a new therapeutic strategy in treating patients with degenerative disc disease lumbar intervertebral fusion with instrumented posterolateral autologous mesenchymal stem cells and arranged in a calcium phosphate ceramic (Conduit TM).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSC seeded onto a phosphate ceramic | Experimental | Procedure: Instrumented posterolateral arthrodesisInstrumented posterolateral fusion and autologous mesenchymal stem cells arranged in a phosphate ceramic. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical
- Box symptomatic (back pain and / or root) of lumbar degenerative disc disease monosegmental.
- Discopathy refractory to conservative treatment (drugs, physical therapy.)
- Evolution greater than or equal to 6 months. Radiological
- Discopathy radiation. Disc space narrowing, osteophytes, abnormal mobility, etc
Key exclusion criteria (6 listed)
- Rejection of surgical treatment.
- Systemic inflammatory disease (spondylitis, rheumatoid arthritis etc), tumor or infection.
- Immunosuppressive treatment.
- Congenital or acquired anatomical abnormality that prevents the surgical procedure.
- Neuropsychiatric pathology, drug addiction, psychosis, severe personality disorder.
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 |
|---|---|---|
| Instrumented posterolateral arthrodesisCell suspension of 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 used a minimum dose of 0.5 x106 CSM / kg and a maximum of 1, 5x106 CSM / kg of patient weight. Dosage Form: Suspension cell support hydroxyapatite and calcium phosphate Route of administration: placement in the fusion bed during surgery. | Procedure or surgery | MSC seeded onto a phosphate ceramic |
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 2 Jun 2017.
- Derived from this study: PubMed 37038216Gomez-Ruiz V, Blanco JF, Villaron EM, Fidalgo H, Lopez-Parra M, Sanchez-Guijo F. Autologous mesenchymal stem cell transplantation for spinal fusion: 10 years follow-up of a phase I/II clinical trial. Stem Cell Res Ther. 2023 Apr 11;14(1):78. doi: 10.1186/s13287-023-03298-4.
- Derived from this study: PubMed 30795797Blanco JF, Villaron EM, Pescador D, da Casa C, Gomez V, Redondo AM, Lopez-Villar O, Lopez-Parra M, Muntion S, Sanchez-Guijo F. Autologous mesenchymal stromal cells embedded in tricalcium phosphate for posterolateral spinal fusion: results of a prospective phase I/II clinical trial with long-term follow-up. Stem Cell Res Ther. 2019 Feb 22;10(1):63. doi: 10.1186/s13287-019-1166-4.
- 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 1/2 study testing Instrumented posterolateral arthrodesis in people with Intervertebral Disc Disease, 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 6 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: finished, as of the sponsor's last update on 2 Jun 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01513694, which also lists 2 linked publications.
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 2 Jun 2017.