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Allogenic Mesenchymal Stem Cells And Physical Therapy for MS Treatment

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ClinicalTrials.gov Identifier: NCT03326505
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Fatima Jamali, University of Jordan

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Biological: Umbilical cord derived Mesenchymal Stem Cells Other: Supervised physical therapy Phase 1 Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Stem Cell Therapy and Comprehensive Physical Therapy in Motor and Non-Motor Symptoms in Patients With Multiple Sclerosis: A Comparative Study.
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Injection of Umbilical cord derived UC- MSCs
Allogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients
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
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
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
Active Comparator: Supervised Physical Therapy (SPT)
Supervised physical therapy program without stem cells
Other: Supervised physical therapy
A combined physical therapy program of Balance, strengthening and endurance exercises
Other Name: SPT



Primary Outcome Measures :
  1. Relevant adverse events will be observed [ Time Frame: 12 months ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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


  4. 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).

  5. 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)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326505


Contacts
Contact: Fatima Ab Jamali, PhD 009625355000 ext 23960 ftmjamali@gmail.com
Contact: Dana Ma Hattab, PhD 009625355000 ext 23960 d.hattab@ju.edu.jo

Locations
Jordan
Cell Therapy Center, University of Jordan Recruiting
Amman, Jordan, 11942
Contact: Fatima Jamali, PhD    009625355000 ext 23960    ftmjamali@gmail.com   
Cell Therapy Center Recruiting
Amman, Jordan, 11942
Contact: Fatima Ab Jamali, PhD    009625355000 ext 23960      
Contact: Dana Ma Hattab, PhD    009625355000 ext 23960      
Sponsors and Collaborators
University of Jordan
Investigators
Study Director: Abdallah Awidi, MD Cell Therapy Center

Responsible Party: Fatima Jamali, Head of Neuroscience Research, University of Jordan
ClinicalTrials.gov Identifier: NCT03326505     History of Changes
Other Study ID Numbers: ALLOMSUJCTC
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fatima Jamali, University of Jordan:
Umbilical Cord Mesenchymal Stem Cells
Multiple Sclerosis
Neuroimmunology
Autoimmune disease
Physical therapy

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases