Allogenic Mesenchymal Stem Cells And Physical Therapy for MS Treatment

Phase 1

Completed

• Conditions: Multiple Sclerosis
• Interventions: Biological: Umbilical cord derived Mesenchymal Stem Cells; Other: Supervised physical therapy

• Registration Number: NCT03326505
• Lead Sponsor: University of Jordan

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 Timeline

• Study First Submitted: 2017-05-09
• Study Start: 2017-09-25
• Study First Submitted QC: 2017-10-25
• Study First Posted: 2017-10-31
• Primary Completion: 2020-01-25
• Status Verified: 2020-02
• Study Completion: 2020-02-20
• Last Update Submitted: 2020-02-28
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
injection of UC- MSCs and SPT	Umbilical cord derived Mesenchymal Stem Cells	Allogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients along with a supervised physical therapy program
Injection of Umbilical cord derived UC- MSCs	Umbilical cord derived Mesenchymal Stem Cells	Allogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients
injection of UC- MSCs and SPT	Supervised physical therapy	Allogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients along with a supervised physical therapy program
Supervised Physical Therapy (SPT)	Supervised physical therapy	Supervised physical therapy program without stem cells

Primary Outcome Measures

Name	Time	Method
Isolation and Expansion of Mesenchymal Stem Cells	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

Name	Time	Method
Biological Assessments	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.
Measuring Non-motor outcomes to assess treatment efficacy.	3-6 months	Clinical Tests ,all patients will be evaluated clinically using qualitative and quantitative tests.
Safety and Efficacy Assessment Pre and Post Treatment	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.
Motor Functions Assessments	3-12 months	A number of motor function tests will be performed with every follow up visit for all 30 patients.

Trial Locations

Locations (2)

Cell Therapy Center; 🇯🇴 Amman, Jordan

Cell Therapy Center, University of Jordan; 🇯🇴 Amman, Jordan