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Allogenic Mesenchymal Stem Cells And Physical Therapy for MS Treatment

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 1
Locations
Jordan
Study Type
Interventional
Intervention
Umbilical cord derived Mesenchymal Stem Cells
Supervised physical therapy
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Umbilical Cord Mesenchymal Stem Cells, Multiple Sclerosis, Neuroimmunology, Autoimmune disease, Physical therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cell Therapy Center, University of Jordan
  • Cell Therapy Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Injection of Umbilical cord derived UC- MSCs

injection of UC- MSCs and SPT

Supervised Physical Therapy (SPT)

Arm Description

Allogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients

Allogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients along with a supervised physical therapy program

Supervised physical therapy program without stem cells

Outcomes

Primary Outcome Measures

Isolation and Expansion of Mesenchymal Stem Cells
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

Safety and Efficacy Assessment Pre and Post Treatment
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
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.
Clinical Tests ,all patients will be evaluated clinically using qualitative and quantitative tests.
Biological Assessments
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.

Full Information

First Posted
May 9, 2017
Last Updated
February 28, 2020
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT03326505
Brief Title
Allogenic Mesenchymal Stem Cells And Physical Therapy for MS 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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 25, 2017 (Actual)
Primary Completion Date
January 25, 2020 (Actual)
Study Completion Date
February 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Umbilical Cord Mesenchymal Stem Cells, Multiple Sclerosis, Neuroimmunology, Autoimmune disease, Physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Injection of Umbilical cord derived UC- MSCs
Arm Type
Active Comparator
Arm Description
Allogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients
Arm Title
injection of UC- MSCs and SPT
Arm Type
Active Comparator
Arm Description
Allogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients along with a supervised physical therapy program
Arm Title
Supervised Physical Therapy (SPT)
Arm Type
Active Comparator
Arm Description
Supervised physical therapy program without stem cells
Intervention Type
Biological
Intervention Name(s)
Umbilical cord derived Mesenchymal Stem Cells
Other Intervention Name(s)
UC-MSCs
Intervention Description
Allogenic umbilical cord derived stem cells which are to be injected intrathecally as a treatment option for consenting MS patients
Intervention Type
Other
Intervention Name(s)
Supervised physical therapy
Other Intervention Name(s)
SPT
Intervention Description
A combined physical therapy program of Balance, strengthening and endurance exercises
Primary Outcome Measure Information:
Title
Isolation and Expansion of Mesenchymal Stem Cells
Description
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.
Time Frame
3-6 months
Secondary Outcome Measure Information:
Title
Safety and Efficacy Assessment Pre and Post Treatment
Description
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.
Time Frame
3-12 months
Title
Motor Functions Assessments
Description
A number of motor function tests will be performed with every follow up visit for all 30 patients.
Time Frame
3-12 months
Title
Measuring Non-motor outcomes to assess treatment efficacy.
Description
Clinical Tests ,all patients will be evaluated clinically using qualitative and quantitative tests.
Time Frame
3-6 months
Title
Biological Assessments
Description
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.
Time Frame
3-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdallah Awidi, MD
Organizational Affiliation
Cell Therapy Center
Official's Role
Study Director
Facility Information:
Facility Name
Cell Therapy Center, University of Jordan
City
Amman
ZIP/Postal Code
11942
Country
Jordan
Facility Name
Cell Therapy Center
City
Amman
ZIP/Postal Code
11942
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32846775
Citation
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.
Results Reference
derived

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Allogenic Mesenchymal Stem Cells And Physical Therapy for MS Treatment

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