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Allogenic Mesenchymal Stem Cells And Physical Therapy for MS Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03326505
Recruitment Status : Completed
First Posted : October 31, 2017
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Fatima Jamali, University of Jordan

Tracking Information
First Submitted Date  ICMJE May 9, 2017
First Posted Date  ICMJE October 31, 2017
Last Update Posted Date March 4, 2020
Actual Study Start Date  ICMJE September 25, 2017
Actual Primary Completion Date January 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2020)
Isolation and Expansion of Mesenchymal Stem Cells [ Time Frame: 3-6 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2017)
Relevant adverse events will be observed [ Time Frame: 12 months ]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2020)
  • Safety and Efficacy Assessment Pre and Post Treatment [ Time Frame: 3-12 months ]
    Outcome measures will be assessed at 3 months pre-treatment, baseline (prior injections), 3 months, 6 months, and 12 months. Informed consent will be obtained in writing from each subject prior to participation in the study. If the subject is unable to give consent or he/she scores less than 24 on the Mini Mental Status Examination (MMSE), they will be excluded from the study. The research personnel involved in the study will carefully explain the consent form to the subject. The subject will then be given ample opportunity to ask questions prior agreeing to participate. If the need arises the research personnel will be available to answer questions and address any concerns.
  • Motor Functions Assessments [ Time Frame: 3-12 months ]
    A number of motor function tests will be performed with every follow up visit for all 30 patients.
  • Measuring Non-motor outcomes to assess treatment efficacy. [ Time Frame: 3-6 months ]
    Clinical Tests ,all patients will be evaluated clinically using qualitative and quantitative tests.
  • Biological Assessments [ Time Frame: 3-12 months ]
    Blood samples will be collected pre and post treatment for immediate or ulterior analysis. Results will be compared between individuals and then between the two groups that received one or two doses of UC-MSCs.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2017)
  • Measuring Magnetic Resonance Imaging (MRI) outcomes of the treatment [ Time Frame: 12 months ]
    The number, intensity and volume of CNS lesions will be assessed to investigate the therapeutic benefits of the injected Allogenic Mesenchymal Stem Cells and/or Physical therapy by MRI. When combined they determine the activity of MS in the CNS tissue. For every patient tests would be performed at baseline and repeated at 3, 6, and 12 months post-injection
  • Measuring motor outcomes to assess treatment efficacy [ Time Frame: 12 months ]
    For every patient tests would be performed at baseline and repeated at 3, 6, and 12 months. Motor tests include the Submaximal Oxygen volume in milliliter per kilogram per minute (mL/Kg-min) which indicates the fitness and physical ability of MS patients.
  • Measuring Non-motor outcomes to assess treatment efficacy [ Time Frame: 12 months ]
    For every patient tests would be performed at baseline and repeated at 3, 6, and 12 months. Non-Motor questionnaires include the Stroop T Symbol Digit Modalities Test to assess the cognitive status of patients at each visit. 4. 9-Hole Peg Test 5. Dynamic Gait Index
  • ophthalmological tests to assess the therapeutic benefits of injected MSCs [ Time Frame: 12 months ]
    Visual Evoked Potential (VEP) that measures speed of response to signal measured in milliseconds (ms).
  • ophthalmological tests to assess the therapeutic benefits of injected MSCs [ Time Frame: 12 months ]
    Optical Coherence Tomography (OCT) that measure the corneal thickness in micrometers (um)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Allogenic Mesenchymal Stem Cells And Physical Therapy for MS Treatment
Official Title  ICMJE The Effect of Stem Cell Therapy and Comprehensive Physical Therapy in Motor and Non-Motor Symptoms in Patients With Multiple Sclerosis: A Comparative Study.
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.
Detailed Description

Umbilical cord derived MSCs bank will be generated and all patients given the same cells from the same biological sample.

Thorough clinical, cognitive and motor analysis will be performed at baseline and compared to outcomes at 3 different time points of all enrolled patients.

The study will consist of three arms: 1- Stem cells treatment 2- Stem cells and supervised physical therapy 3- Supervised physical therapy

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Biological: Umbilical cord derived Mesenchymal Stem Cells
    Allogenic umbilical cord derived stem cells which are to be injected intrathecally as a treatment option for consenting MS patients
    Other Name: UC-MSCs
  • Other: Supervised physical therapy
    A combined physical therapy program of Balance, strengthening and endurance exercises
    Other Name: SPT
Study Arms  ICMJE
  • Active Comparator: Injection of Umbilical cord derived UC- MSCs
    Allogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients
    Intervention: Biological: Umbilical cord derived Mesenchymal Stem Cells
  • Active Comparator: injection of UC- MSCs and SPT
    Allogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients along with a supervised physical therapy program
    Interventions:
    • Biological: Umbilical cord derived Mesenchymal Stem Cells
    • Other: Supervised physical therapy
  • Active Comparator: Supervised Physical Therapy (SPT)
    Supervised physical therapy program without stem cells
    Intervention: Other: Supervised physical therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 20, 2020
Actual Primary Completion Date January 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Jordan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03326505
Other Study ID Numbers  ICMJE ALLOMSUJCTC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fatima Jamali, University of Jordan
Study Sponsor  ICMJE University of Jordan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Abdallah Awidi, MD Cell Therapy Center
PRS Account University of Jordan
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP