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

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Phase 1

Locations

Jordan

Study Type

Interventional

Intervention

Autologous Mesenchymal Stem Cells

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Bone marrow derived Mesenchymal Stem Cells, Multiple Sclerosis, Oligodendrocytes, Neuroimmunology, Autoimmune disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Cell Therapy Center, Jordan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MSCs injection

Arm Description

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

Outcomes

Primary Outcome Measures

The number of patients with any relevant side effects observed

Assessing the safety of autologous Mesenchymal Stem Cells injection

Secondary Outcome Measures

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

For every patient tests would be performed at baseline and repeated at 3, 6, and 18 months post-injection

Full Information

NCT ID

NCT01895439

First Posted

June 24, 2013

Last Updated

May 1, 2017

Sponsor

University of Jordan

1. Study Identification

Unique Protocol Identification Number

NCT01895439

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Jordan

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MSCs injection

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Autologous Mesenchymal Stem Cells

Primary Outcome Measure Information:

Title

The number of patients with any relevant side effects observed

Description

Assessing the safety of autologous Mesenchymal Stem Cells injection

Time Frame

18 months

Secondary Outcome Measure Information:

Title

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

Description

For every patient tests would be performed at baseline and repeated at 3, 6, and 18 months post-injection

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abdallah Awidi, MD.

Organizational Affiliation

Cell Therapy Center

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Said Dahbour, MD.

Organizational Affiliation

Jordan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cell Therapy Center, Jordan University Hospital

City

Amman

ZIP/Postal Code

11942

Country

Jordan

12. IPD Sharing Statement

Learn more about this trial

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

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