Autologous Bone Marrow Derived Stem Cells for the Treatment of Multipl
Safety and Efficacy of Immuno-modulation and Autologous Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Multiple Sclerosis.
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Stem Cell Transplantation
What it measured
Main measures
Effectiveness assessment by MRI
6 months
MRI lesionsSafety assessment by physical examination, vital signs, analytical results, electrocardiograph monitoring, and Expanded Disability Status Scale (EDSS)
12 months
Disability progressionSafety
Other measures (3)
Change in Quality of life by Multiple Sclerosis Quality of Life (MSQOL-54)
6 months
Quality of life (reported by participants)Axonal effect by Optical coherence tomography (OCT)
6 months
Retina scans (OCT)Immunology: Dosing of G, A and M immunoglobulins, and complement factors C3 and C4
1 month
Who could take part
Relapsing MS · 20 to 65 · EDSS 3.0 to 6.5
Show the full criteria
Inclusion criteria
* Relapsing-remitting MS (RRMS) patients * Age 18-50 years * Disease duration >= 2 and \<= 10 years * EDSS: 3.0 - 6.5
Exclusion criteria
* RRMS not fulfilling inclusion criteria * SPMS or PPMSTreatment with any immunosuppressive therapy * Treatment with interferon-beta or glatiramer acetate within the 30 days prior to transplantation * Treatment with corticosteroids within the 30 days prior to transplantation * Relapse occurred during the 60 days prior to transplantation * History of cancer or clinical or laboratory results indicative of severe systemic diseases, including infection for HIV, Hepatitis B or C * Pregnancy or risk of pregnancy/ lactation * Current treatment with an investigational therapy * Inability to give written informed consent in accordance with research ethics board guidelines
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Until now, there is no effective approach to stop the progression of multiple sclerosis and stimulate re-myelination. Autologous stem cell transplantation shows hope and is quickly developing as an alternative therapy. We propose the use of autologous bone marrow-derived specific stem cell populations and mesenchymal stem cell transplantation (BM-MSC) associated with immuno-modulation to treat patients with relapsing-remitting MS (RRMS).
Papers
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History
Started
Jul 2016
Main results due
Sept 2020
Finished
Jan 2021