Allogenic Mesenchymal Stem Cells And Physical Therapy for MS Treatment

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

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older 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.

Contacts and Locations

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

More Information

• Responsible Party: Fatima Jamali, Head of Neuroscience Research, University of Jordan
• ClinicalTrials.gov Identifier: NCT03326505
• Other Study ID Numbers: ALLOMSUJCTC
• First Posted: October 31, 2017
• 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:

Multiple Sclerosis; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases