Clinical trial NCT03326505: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Sclerosis
Keywords: Umbilical Cord Mesenchymal Stem Cells
Multiple Sclerosis
Neuroimmunology
Autoimmune disease
Physical therapy
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Isolation and Expansion of Mesenchymal Stem Cells
timeFrame: 3-6 months
Secondary outcomes:
measure: Safety and Efficacy Assessment Pre and Post Treatment
timeFrame: 3-12 months
measure: Motor Functions Assessments
timeFrame: 3-12 months
measure: Measuring Non-motor outcomes to assess treatment efficacy.
timeFrame: 3-6 months
measure: Biological Assessments
timeFrame: 3-12 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Cell Therapy Center, University of Jordan
city: Amman
country: Jordan
facility: Cell Therapy Center
Study officials:
affiliation: Cell Therapy Center
name: Abdallah Awidi, MD
role: STUDY_DIRECTOR
References:
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.