Autologous Mesenchymal Stromal Cells for Multiple Sclerosis
Treatment of Autologous Mesenchymal Stem Cells Derived From Bone Marrow as a Potential Therapeutic Strategy for the Treatment of Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 8 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- XCEL-MC-ALPHA
- Autologous adult mesenchymal stem cells from bone marrow expanded and cryopreserved
Placebo
- Placebo
What it measured
Main measures
Adverse events
12 months
SafetySafety and tolerability
Safety
Other measures (5)
Cumulative number of MRI Gd-enhancing lesions
12 months
MRI lesionsMultiple Sclerosis Outbreaks
12 months
Expanded Disability Status Scale (EDDS) score
12 months
Disability progressionCumulative number of lesions visualized on T2 sequence
12 months
MRI lesionsLesions that enhance with gadolinium T1 in sequence magnetic resonance
MRI lesions
Who could take part
Relapsing and progressive · 18 to 60
Show the full criteria
Inclusion criteria
* Patients between 18 and 60 years of age * Patients with MS * Relapsing-remitting or secondary progressive MS * Patients to whom are not indicated or are not in a position to initiate treatment with disease-modifying drugs * Expanded Disability Status Scale (EDDS) score \<6.5 * Nine T2 lesions at least * Active multiple sclerosis as defined either by 1 outbreak in the last year or at least one Gadolinium-enhancing lesion in the last 6 months * Signed informed consent form
Exclusion criteria
* Interferon beta or glatiramer acetate 3 months prior the screening * Natalizumab or fingolimod in the 6 months prior the screening * Mitoxantrone, cyclophosphamide or other immunosuppressive therapy at any time * Has received an experimental treatment within 3 months prior the screening * MS outbreak within the 4 weeks prior the randomization * Serum creatinine> 2.0 mg/dl * Infectious disease active or uncontrolled * Fertile patients who are not using a suitable method of contraception * Pregnant or lactating woman * Immunodeficiency * Positive serology to HIV, Hepatitis B, Hepatitis C or syphilis
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study evaluates the effect of cryopreserved autologous adult bone-marrow mesenchymal stromal cells (BM-MSC) in patients with active multiple sclerosis, compared to placebo. Patients will be allocated to one of the 2 treatment arms (BM-MSC or placebo)and at month 6, the treatment will be crossed to receive the other product. The objective is to assess the safety of a single infusion BM-MSC, and to explore its efficacy in these patients. Patients will be evaluated at month 12 and will be followed-up for a total of 3 years.
Papers
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History
Started
May 2015
Main results due
Nov 2017
Finished
Nov 2018