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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01895439

Enrollment

Registered

2013-07-10

Start date

2012-10-31

Completion date

2016-02-29

Last updated

2017-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Bone marrow derived Mesenchymal Stem Cells, Multiple Sclerosis, Oligodendrocytes, Neuroimmunology, Autoimmune disease

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.

Interventions

BIOLOGICALAutologous Mesenchymal Stem Cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026