Allogenic Mesenchymal Stem Cells And Physical Therapy for MS Treatment
The Effect of Stem Cell Therapy and Comprehensive Physical Therapy in Motor and Non-Motor Symptoms in Patients With Multiple Sclerosis: A Comparative Study.
1 other identifier
interventional
60
1 country
2
Brief Summary
This study aims at expanding Umbilical Cord derived Mesenchymal Stem Cells (MSCs) to a clinical scale according to Good Laboratory Practice and study its efficacy when compared to a Supervised Physical Therapy Program alone.
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 Sep 2017
2 active sites
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
First Submitted
Initial submission to the registry
May 9, 2017
CompletedStudy Start
First participant enrolled
September 25, 2017
CompletedFirst Posted
Study publicly available on registry
October 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2020
CompletedMarch 4, 2020
February 1, 2020
2.3 years
May 9, 2017
February 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Isolation and Expansion of Mesenchymal Stem Cells
To isolate stem cells from UC: first, the cord will be cut into small pieces around (4-5cm) and washed with phosphate buffered saline, then the umbilical vein and the two arteries will be removed.These pieces will be placed in culture plate and cultured in UC-MSCs medium consist of; alpha modification of Minimum Essential Medium (α-MEM) supplemented with 10% fetal bovine serum, 1% glutamine, 1% penicillin/streptomycin and 1 μg/mL amphotericin B.After incubation period the undigested tissue will be discarded and nucleated cells will be pelleted by centrifugation at 450xg for 10 minutes. Cell pellet will be re-suspended in UC-MSCs culture medium, cultured in tissue culture flasks and placed in CO2 incubator at 37°C, 5% CO2. Cells will be expanded in multilayer cell factory tissue culture flasks to reach an estimated 108 UC-MSCs that will be frozen in bags of 106 cells for subsequent thawing and administration.
3-6 months
Secondary Outcomes (4)
Safety and Efficacy Assessment Pre and Post Treatment
3-12 months
Motor Functions Assessments
3-12 months
Measuring Non-motor outcomes to assess treatment efficacy.
3-6 months
Biological Assessments
3-12 months
Study Arms (3)
Injection of Umbilical cord derived UC- MSCs
ACTIVE COMPARATORAllogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients
injection of UC- MSCs and SPT
ACTIVE COMPARATORAllogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients along with a supervised physical therapy program
Supervised Physical Therapy (SPT)
ACTIVE COMPARATORSupervised physical therapy program without stem cells
Interventions
Allogenic umbilical cord derived stem cells which are to be injected intrathecally as a treatment option for consenting MS patients
A combined physical therapy program of Balance, strengthening and endurance exercises
Eligibility Criteria
You may qualify if:
- A clinical diagnosis of definite MS according to the revised McDonald Criteria.
- Expanded Disability Status Scale (EDSS) ≤ 7
- Failure of standard medical therapy
- Disease duration of at least three years prior to enrollment.
You may not qualify if:
- Pregnant and lactating women
- Previous treatment with immunosuppressive agents in the last 12 months prior to enrollment
- Recent MS relapse in the month prior to enrollment
- Treatment with oral or parenteral steroids for any cause in the month prior to enrollment
- Significant systemic medical disorders including cardiac, renal, hepatic, hematologic, immunologic or endocrine disorders
- Previous treatment with interferons or glatiramer acetate in the 3 months prior to enrollment
- Any contra-indication for magnetic resonance imaging (MRI) or gadolinium contrast.
- Positive serology for HIV, Hepatitis B or Hepatitis C
- Any history of malignancy or exposure to radiation at any time prior to enrollment
- Any contra-indication to lumbar puncture
- Severe cognitive impairment that would interfere with the patient's ability to understand and sign the informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cell Therapy Center, University of Jordan
Amman, 11942, Jordan
Cell Therapy Center
Amman, 11942, Jordan
Related Publications (1)
Alghwiri AA, Jamali F, Aldughmi M, Khalil H, Al-Sharman A, Alhattab D, Al-Radaideh A, Awidi A. The effect of stem cell therapy and comprehensive physical therapy in motor and non-motor symptoms in patients with multiple sclerosis: A comparative study. Medicine (Baltimore). 2020 Aug 21;99(34):e21646. doi: 10.1097/MD.0000000000021646.
PMID: 32846775DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Abdallah Awidi, MD
Cell Therapy Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Neuroscience Research
Study Record Dates
First Submitted
May 9, 2017
First Posted
October 31, 2017
Study Start
September 25, 2017
Primary Completion
January 25, 2020
Study Completion
February 20, 2020
Last Updated
March 4, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share