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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895439
• Other study ID #: MSUJCTC
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 24, 2013
• Last updated: May 1, 2017
• Start date: October 2012
• Est. completion date: February 2016

Study information

• Verified date: May 2017
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Biological:
• Autologous Mesenchymal Stem Cells

Locations

Country	Name	City	State
Jordan	Cell Therapy Center, Jordan University Hospital	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

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