Allogenic Mesenchymal Stem Cells And Physical Therapy for MS Treatment

Multiple Sclerosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326505
• Other study ID #: ALLOMSUJCTC
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 25, 2017
• Est. completion date: February 20, 2020

Study information

• Verified date: February 2020
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 20, 2020
• Est. primary completion date: January 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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:
• Supervised physical therapy
A combined physical therapy program of Balance, strengthening and endurance exercises

Locations

Country	Name	City	State
Jordan	Cell Therapy Center	Amman
Jordan	Cell Therapy Center, University of Jordan	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (a-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.	3-6 months
Secondary	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.	3-12 months
Secondary	Motor Functions Assessments	A number of motor function tests will be performed with every follow up visit for all 30 patients.	3-12 months
Secondary	Measuring Non-motor outcomes to assess treatment efficacy.	Clinical Tests ,all patients will be evaluated clinically using qualitative and quantitative tests.	3-6 months
Secondary	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.	3-12 months