NCT04823000

Brief Summary

An open prospective study with multiple (every 6-12 months) intrathecal or intravenous injections of autologous MSC in patients with progressive forms of MS (secondary progressive, primary progressive or relapsing-progressive), who failed to respond to first and second lines of immunomodulatory treatments and deteriorated (at least 0.5 degree in the EDSS scale) during the year preceding their inclusion to our study or had at least one major relapse without sufficient recovery.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P50-P75 for phase_1 multiple-sclerosis

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_1 multiple-sclerosis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
Last Updated

March 30, 2021

Status Verified

November 1, 2020

Enrollment Period

3.9 years

First QC Date

January 11, 2021

Last Update Submit

March 26, 2021

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisMesenchymal Stem Cells

Outcome Measures

Primary Outcomes (2)

  • Appearance of adverse events

    To evaluate the safety and tolerability of MSCs repeated treatment in progressive MS patients

    48 months following first treatment

  • The changes in Expanded Disability Status Scale (EDSS) score 0-10 scale, higher scores show worsening of disability)

    To evaluate the changes in Expanded Disability Status Scale (EDSS) score after repeated MSC treatments compared to run-in period.

    48 months

Secondary Outcomes (4)

  • Changes in the percentage of CD4/CD25/FoxP3 triple positive stained cells (T regulatory cells), following MSC-treatment

    up to 6 months

  • Changes in the percentage of CD3+CD69+ cells (activated lymphocytes), following MSC-treatment

    up to 6 months

  • Changes in the percentage of CD11c+/CD86+/Lin- cells (dendritic cells and antigen-presenting macrophages), following MSC-treatment

    up to 6 months

  • Changes in the proliferation ability of mononuclear cells to PHA, following MSC-treatment

    up to 6 months

Study Arms (1)

Repeated MSCs treatment in MS patients

EXPERIMENTAL

Treatment with intrathecal and intravenous injection of autologous MSC (1 million cells per Kg of body weight)

Biological: Mesenchymal Stem Cells (MSC)

Interventions

Mesenchymal Stem Cells (MSC)BIOLOGICAL

Repeated intrathecal and intravenous injection of autologous mesenchymal stem cells (1 million cells per Kg of body weight) at 6 months intervals.

Also known as: MSC
Repeated MSCs treatment in MS patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consenting patients fulfilling the Poser's criteria for definite MS
  • Age 18-70
  • Male and female
  • EDSS rate 5.5-7.5 (moderate to high disability)

You may not qualify if:

  • Patients who were treated with cytotoxic medications during the last three months prior to the infusion.
  • Patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to interpret the results.
  • Patients with active infections.
  • Patients with cognitive decline or inability to understand and sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Petrou P, Kassis I, Ginzberg A, Halimi M, Yaghmour N, Abramsky O, Karussis D. Long-Term Clinical and Immunological Effects of Repeated Mesenchymal Stem Cell Injections in Patients With Progressive Forms of Multiple Sclerosis. Front Neurol. 2021 May 31;12:639315. doi: 10.3389/fneur.2021.639315. eCollection 2021.

    PMID: 34135843DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Dimitrios Karussis, PhD

    Hadassah HMO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single Center, Open phase study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2021

First Posted

March 30, 2021

Study Start

January 1, 2013

Primary Completion

December 1, 2016

Study Completion

April 1, 2020

Last Updated

March 30, 2021

Record last verified: 2020-11