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

NCT01895439 | Completed Phase 1

• 1 other identifier: MSUJCTC
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Assessing the safety of injecting autologous BM-MSCs to Multiple Sclerosis (MS)patients who fail to respond to conventional treatment.
3. 3.Assessing the therapeutic benefits on the participants in the trial as per established methods.

Conditions

Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The number of patients with any relevant side effects observed

  Assessing the safety of autologous Mesenchymal Stem Cells injection

  18 months

Secondary Outcomes (1)

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

  18 months

Study Arms (1)

MSCs injection

EXPERIMENTAL

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

Biological: Autologous Mesenchymal Stem Cells

Interventions

Autologous Mesenchymal Stem Cells BIOLOGICAL

MSCs injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Cell Therapy Center, Jordan University Hospital

Amman, 11942, Jordan

Location

MeSH Terms

Conditions

Multiple Sclerosis; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Immune System Diseases

Study Officials

• Abdallah Awidi, MD.

  Cell Therapy Center

  STUDY DIRECTOR

• Said Dahbour, MD.

  Jordan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: July 10, 2013
• Study Start: October 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 2, 2017

Record last verified: 2017-05

Locations

JO (1)