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Trial record 29 of 75 for:    stem cell multiple sclerosis

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

Tracking Information
First Submitted Date  ICMJE May 9, 2017
First Posted Date  ICMJE October 31, 2017
Last Update Posted Date October 31, 2017
Actual Study Start Date  ICMJE September 25, 2017
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current 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)
Original Secondary Outcome Measures  ICMJE Same as current
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 25, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2019   (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: Fatima Ab Jamali, PhD 009625355000 ext 23960 ftmjamali@gmail.com
Contact: Dana Ma Hattab, PhD 009625355000 ext 23960 d.hattab@ju.edu.jo
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 October 2017

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