Autologous Bone Marrow Derived Stem Cells for the Treatment of Multiple Sclerosis.

March 15, 2020 updated by: Stem Cells Arabia

Safety and Efficacy of Immuno-modulation and Autologous Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Multiple Sclerosis.

Until now, there is no effective approach to stop the progression of multiple sclerosis and stimulate re-myelination. Autologous stem cell transplantation shows hope and is quickly developing as an alternative therapy. We propose the use of autologous bone marrow-derived specific stem cell populations and mesenchymal stem cell transplantation (BM-MSC) associated with immuno-modulation to treat patients with relapsing-remitting MS (RRMS).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Multiple sclerosis (MS) is an autoimmune de-myelinating disease in which the myelin sheaths of nerve cells in the central nervous system are damaged.This damage disrupts the ability of parts of the nervous system to communicate, resulting in a range of signs and symptoms, including physical, mental, and psychiatric issues. To date, There is no known cure for multiple sclerosis. Treatments attempt to improve function after an attack and prevent new attacks.

Stem cells possess strong immunomodulatory properties that are shown to play a role in the maintenance of peripheral tolerance and in the control of autoimmunity and that may stimulate repair and regeneration of lesion. Clinical studies have shown that stem cells can be safely harvested and do not form tumors. Most of human stem cell trials have focused on clinical applications for haematopoietic stem cells (HSC), mesenchymal stem cells (MSC), or both. When administered intravenously they have an immune inhibitory effect that can ameliorate animal autoimmune diseases. MSC transplantation significantly improves clinical outcome in experimental allergic encephalitis (EAE). When administered intravenously, MSC may migrate to inflammatory brain lesions and promote survival of nervous cells. Hence, MSC have become the focus of studies as a potential cell therapy for stimulating neuro-protection in human neurodegenerative diseases such as MS.

We propose a safety and efficacy trial of a intravenous and intrathecal injections of autologous bone marrow-derived stem cells into patients with MS.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Relapsing-remitting MS (RRMS) patients
  • Age 18-50 years
  • Disease duration >= 2 and <= 10 years
  • EDSS: 3.0 - 6.5

Exclusion Criteria:

  • RRMS not fulfilling inclusion criteria
  • SPMS or PPMSTreatment with any immunosuppressive therapy
  • Treatment with interferon-beta or glatiramer acetate within the 30 days prior to transplantation
  • Treatment with corticosteroids within the 30 days prior to transplantation
  • Relapse occurred during the 60 days prior to transplantation
  • History of cancer or clinical or laboratory results indicative of severe systemic diseases, including infection for HIV, Hepatitis B or C
  • Pregnancy or risk of pregnancy/ lactation
  • Current treatment with an investigational therapy
  • Inability to give written informed consent in accordance with research ethics board guidelines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stem Cells
Intravenous administration of purified autologous bone marrow-derived stem cells.
Biological: Stem Cell Transplantation
Intravenous and Intrathecal injections of purified autologus bone marrow-derived stem cells.
Experimental: Stem Cell Transplantation
Intrathecal administration of purified autolgous bone-marrow derived stem cells.
Biological: Stem Cell Transplantation
Intravenous and Intrathecal injections of purified autologus bone marrow-derived stem cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effectiveness assessment by MRI
Time Frame: 6 months
6 months
Safety assessment by physical examination, vital signs, analytical results, electrocardiograph monitoring, and Expanded Disability Status Scale (EDSS)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Quality of life by Multiple Sclerosis Quality of Life (MSQOL-54)
Time Frame: 6 months
6 months
Axonal effect by Optical coherence tomography (OCT)
Time Frame: 6 months
6 months
Immunology: Dosing of G, A and M immunoglobulins, and complement factors C3 and C4
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stem Cells Arabia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

February 25, 2017

First Submitted That Met QC Criteria

February 25, 2017

First Posted (Actual)

March 3, 2017

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 15, 2020

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCA-MS1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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