Autologous Bone Marrow Derived Stem Cells for the Treatment of Multiple Sclerosis.
Safety and Efficacy of Immuno-modulation and Autologous Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Multiple Sclerosis.
1 other identifier
interventional
50
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 multiple-sclerosis
Started Jul 2016
Longer than P75 for phase_1 multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 25, 2017
CompletedFirst Posted
Study publicly available on registry
March 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedMarch 17, 2020
June 1, 2019
4.2 years
February 25, 2017
March 15, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Effectiveness assessment by MRI
6 months
Safety assessment by physical examination, vital signs, analytical results, electrocardiograph monitoring, and Expanded Disability Status Scale (EDSS)
12 months
Secondary Outcomes (3)
Change in Quality of life by Multiple Sclerosis Quality of Life (MSQOL-54)
6 months
Axonal effect by Optical coherence tomography (OCT)
6 months
Immunology: Dosing of G, A and M immunoglobulins, and complement factors C3 and C4
1 month
Study Arms (2)
Stem Cells
EXPERIMENTALIntravenous administration of purified autologous bone marrow-derived stem cells.
Stem Cell Transplantation
EXPERIMENTALIntrathecal administration of purified autolgous bone-marrow derived stem cells.
Interventions
Intravenous and Intrathecal injections of purified autologus bone marrow-derived stem cells.
Eligibility Criteria
You may qualify if:
- Relapsing-remitting MS (RRMS) patients
- Age 18-50 years
- Disease duration \>= 2 and \<= 10 years
- EDSS: 3.0 - 6.5
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stem Cells Arabia
Amman, 11953, Jordan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2017
First Posted
March 3, 2017
Study Start
July 1, 2016
Primary Completion
September 1, 2020
Study Completion
January 1, 2021
Last Updated
March 17, 2020
Record last verified: 2019-06