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

University of Jordan

Status and phase: Completed; Phase 2; Phase 1

Conditions: Multiple Sclerosis

Treatments: Biological: Autologous Mesenchymal Stem Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01895439

MSUJCTC

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

MSCs injection

Experimental group

Description:

Autologous bone marrow derived stem cells injected intrathecally to enrolled MS patients

Treatment:

Biological: Autologous Mesenchymal Stem Cells