Autoimmune DiseasesPhase 1/2NCT01056471
Autologous Mesenchymal Stem Cells From Adipose Tissue in Patients With Secondary Progressive Multiple Sclerosis
A Phase 1/2 study testing Autologous mesenchymal stem cells from adipose tissue. in people with Autoimmune Diseases and Immune System Diseases, run by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud at 2 sites in Spain.
Trial summary
The main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with mesenchymal stem cells from adipose tissue, administered intravenously in patients with secondary progressive multiple sclerosis who do not respond to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases, Immune System Diseases, Demyelinating Diseases
- What is being tested?
- Autologous mesenchymal stem cells from adipose tissue.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2010to Jun 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Multiple Sclerosis (Poser and McDonald criteria).
- Secondary progressive MS patients with EDSS ≥ 5.5 and ≤ 9.
- Patients with treatment failure defined by: no response to immunomodulators / immunosuppressants, and showing activity in the form of 1 relapse in the last year or 0.5 points in EDSS progression.
- Patients with no MS relapse and no steroid treatment within the month prior to inclusion.
- Patients who give written consent to participate in the study. -
Who cannot join
- History of current pathology or current laboratory results indicative of any severe disease.
- Pacemaker or metallic implants that prevent MR imaging.
- Inability to complete questionnaires.
- Refusal to give informed consent.
- Predicted impossibility for a biopsy of at least 30 grams of fat tissue.
- Positive screening test for HIV, Hepatitis B or Hepatitis C.
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- History of malignancy.
- Having been in treatment with any investigational drug or have undergone any experimental procedure in the 3 months prior to baseline.
- Body mass index> 40 kg/m2.
- Patients who have been treated with prohibited concomitant medication during the month prior to inclusion in the study.
- Pregnancy or lactation
- -
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Regional Universitario de Málaga
Málaga, Málaga, 29010
Hospital Universitario Virgen Macarena
Seville, Sevilla, 41004
About this study
Official title: Multicenter Clinical Trial Phase I / II Randomized, Placebo-controlled Study to Evaluate Safety and Feasibility of Therapy With Two Different Doses of Autologous Mesenchymal Stem Cells in Patients With Secondary Progressive Multiple Sclerosis Who do Not Respond to Treatment
The main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with mesenchymal stem cells from adipose tissue, administered intravenously in patients with secondary progressive multiple sclerosis who do not respond to treatment.
- Conditions
- Autoimmune Diseases, Immune System Diseases, Demyelinating Diseases, Nervous System Diseases, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System
- Being tested
- Autologous mesenchymal stem cells from adipose tissue.
- Keywords
- Multiple Sclerosis, Mesenchymal Stem Cells, Autologous
- Medical subject headings
- Autoimmune Diseases, Immune System Diseases, Demyelinating Diseases, Nervous System Diseases, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous mesenchymal stem cells from adipose tissue.Other
Intravenous infusion of autologous mesenchymal stem cells.Dose:4*10e6 cells/Kg.
Autologous mesenchymal stem cells from adipose tissue.Other
Intravenous infusion of autologous mesenchymal stem cells. Dose: 10e6 cells/Kg.
| Study group | Role | What they receive |
|---|---|---|
| Low dose autologous mesenchymal cells | Experimental | The dose of infused cells is 10e6 cells/Kg Receives: Other: Autologous mesenchymal stem cells from adipose tissue. |
| High dose | Experimental | The dose of infused cells is 4*10e6 cells/Kg Receives: Other: Autologous mesenchymal stem cells from adipose tissue. |
| Placebo Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells
Measured: 12 months.
Secondary outcomes (1)
To evaluate effects on MS disease activity measured by: clinical variables, imaging variables, immunological and neurophysiologic analysis, neuropsychological and quality of life scales.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2012
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute
- Responsible party
- Sponsor
- Investigators
- Oscar Fernandez Fernandez, MD, PhD, Study director, Hospital Regional Universitario Carlos Haya, Málaga, Spain.Guillermo Izquierdo Ayuso, MD, PhD, Principal investigator, Hospital Universitario Virgen Macarena, Sevilla, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056471
- Sponsor's protocol ID
- CMM/EM/2008
- Status last verified
- Feb 2015
- First submitted
- 25 Jan 2010
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Trial Phase I / II Randomized, Placebo-controlled Study to Evaluate Safety and Feasibility of Therapy With Two Different Doses of Autologous Mesenchymal Stem Cells in Patients With Secondary Progressive Multiple Sclerosis Who do Not Respond to Treatment
- ClinicalTrials.gov ID
- NCT01056471
- Acronym / sponsor ID
- CMM/EM/2008
- Conditions
- Autoimmune Diseases, Immune System Diseases, Demyelinating Diseases, Nervous System Diseases, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System
- Keywords
- Multiple Sclerosis, Mesenchymal Stem Cells, Autologous
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Collaborators
- Carlos III Health Institute
- Study start
- Jan 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Jan 2010 (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 main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with mesenchymal stem cells from adipose tissue, administered intravenously in patients with secondary progressive multiple sclerosis who do not respond to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose autologous mesenchymal cells | Experimental | Other: Autologous mesenchymal stem cells from adipose tissue.The dose of infused cells is 10e6 cells/Kg |
| High dose | Experimental | Other: Autologous mesenchymal stem cells from adipose tissue.The dose of infused cells is 4*10e6 cells/Kg |
| Placebo Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with Multiple Sclerosis (Poser and McDonald criteria).
- Secondary progressive MS patients with EDSS ≥ 5.5 and ≤ 9.
- Patients with treatment failure defined by: no response to immunomodulators / immunosuppressants, and showing activity in the form of 1 relapse in the last year or 0.5 points in EDSS progression.
- Patients with no MS relapse and no steroid treatment within the month prior to inclusion.
- Patients who give written consent to participate in the study. -
Key exclusion criteria (12 listed)
- History of current pathology or current laboratory results indicative of any severe disease.
- Pacemaker or metallic implants that prevent MR imaging.
- Inability to complete questionnaires.
- Refusal to give informed consent.
- Predicted impossibility for a biopsy of at least 30 grams of fat tissue.
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 |
|---|---|---|
| Autologous mesenchymal stem cells from adipose tissue.Intravenous infusion of autologous mesenchymal stem cells.Dose:4*10e6 cells/Kg. | Other | High dose |
| Autologous mesenchymal stem cells from adipose tissue.Intravenous infusion of autologous mesenchymal stem cells. Dose: 10e6 cells/Kg. | Other | Low dose autologous mesenchymal cells |
Primary outcome
To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells
Time frame: 12 months.
1 secondary outcome
To evaluate effects on MS disease activity measured by: clinical variables, imaging variables, immunological and neurophysiologic analysis, neuropsychological and quality of life scales.
Time frame: 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 7 Aug 2015.
- Andalusian Molecular Biology and Regenerative Medicine CentreLink 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.
Oscar Fernandez Fernandez, MD, PhD study director
Hospital Regional Universitario Carlos Haya, Málaga, Spain.
Guillermo Izquierdo Ayuso, MD, PhD principal investigator
Hospital Universitario Virgen Macarena, Sevilla, Spain
2 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 Autologous mesenchymal stem cells from adipose tissue. in people with Autoimmune Diseases and Immune System Diseases, run by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud at 2 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 5 inclusion and 12 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 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells (time frame: 12 months.). It is what the study was designed to measure, not a finding.
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 7 Aug 2015.