Safety and Efficacy Study of Autologus Bone Marrow Mesenchymal Stem Cells in Multiple Sclerosis

Phase 1

Completed

• Conditions: Multiple Sclerosis
• Interventions: Biological: Autologous Mesenchymal Stem Cells

• Registration Number: NCT01895439
• Lead Sponsor: University of Jordan

Brief Summary

1. 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.

2. Assessing the safety of injecting autologous BM-MSCs to Multiple Sclerosis (MS)patients who fail to respond to conventional treatment.

3. Assessing the therapeutic benefits on the participants in the trial as per established methods.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-06-24
• Study First Submitted QC: 2013-07-03
• Study First Posted: 2013-07-10
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• 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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MSCs injection	Autologous Mesenchymal Stem Cells	Autologous bone marrow derived stem cells injected intrathecally to enrolled MS patients

Primary Outcome Measures

Name	Time	Method
The number of patients with any relevant side effects observed	18 months	Assessing the safety of autologous Mesenchymal Stem Cells injection

Secondary Outcome Measures

Name	Time	Method
Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells by Magnetic Resonance Imaging (MRI) and ophthalmological tests.	18 months	For every patient tests would be performed at baseline and repeated at 3, 6, and 18 months post-injection

Trial Locations

Locations (1)

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