Allogenic Mesenchymal Stem Cells And Physical Therapy for MS Treatment

• ClinicalTrials.gov Identifier: NCT03326505
• Recruitment Status: Completed
• First Posted: October 31, 2017
• Last Update Posted: March 4, 2020
• 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)
• Actual 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
• Actual Primary Completion Date: January 25, 2020
• Actual Study Completion Date: February 20, 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. 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.

Secondary Outcome Measures :

1. 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.

2. 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.
3. 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.
4. 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.

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

Locations

Jordan

Cell Therapy Center, University of Jordan

Amman, Jordan, 11942

Cell Therapy Center

Amman, Jordan, 11942

Sponsors and Collaborators

University of Jordan

Investigators

• Study Director: Abdallah Awidi, MD; Cell Therapy Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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: March 4, 2020
• Last Verified: February 2020

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