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

NCT ID: NCT01895439

Last Updated: 2017-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-02-29

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MSCs injection

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

Group Type: EXPERIMENTAL

Autologous Mesenchymal Stem Cells

Intervention Type: BIOLOGICAL

Interventions

Autologous Mesenchymal Stem Cells

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jordan

OTHER

Sponsor Role: lead

Responsible Party

Fatima Jamali

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdallah Awidi, MD.

Role: STUDY_DIRECTOR

Cell Therapy Center

Said Dahbour, MD.

Role: PRINCIPAL_INVESTIGATOR

Jordan University Hospital

Locations

Cell Therapy Center, Jordan University Hospital

Amman, , Jordan

Countries

Jordan

Other Identifiers

MSUJCTC

Identifier Type: -

Identifier Source: org_study_id