Phase II Study: Use of Autologus Mesenchymal Stem Cells in Multiple Sclerosis Patients Who do Not Respond to Conventional Treatment

University of Jordan1 site in 1 country13 target enrollmentOctober 2012

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Multiple Sclerosis
Sponsor: University of Jordan
Enrollment: 13
Locations: 1
Primary Endpoint: The number of patients with any relevant side effects observed
Status: Completed
Last Updated: 9 years ago

Expanding and priming Bone Marrow (BM)- Mesenchymal Stem Cells (MSCs) to a clinical scale according to Good Laboratory Practice using xenogenic free media instead of the previously used FCS.
Assessing the safety of injecting autologous BM-MSCs to Multiple Sclerosis (MS)patients who fail to respond to conventional treatment.
Assessing the therapeutic benefits on the participants in the trial as per established methods.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

February 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Principal Investigator

Fatima Jamali

Researcher

University of Jordan

•A clinical diagnosis of definite MS according to the revised McDonald Criteria.
•Expanded Disability Status Scale (EDSS) ≤ 6
•Failure of standard medical therapy
•Disease duration of at least three years prior to enrollment.

•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

The number of patients with any relevant side effects observed

Time Frame: 18 months

Assessing the safety of autologous Mesenchymal Stem Cells injection

Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells by Magnetic Resonance Imaging (MRI) and ophthalmological tests.(18 months)