NCT01854957

Brief Summary

A double-blind, randomized, cross-over phase I/II study to evaluate the safety and the efficacy of the intravenous administration of autologous Mesenchymal Stem Cells (MSC) to patients with active multiple sclerosis (MS) resistant to currently available therapies.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1 multiple-sclerosis

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

May 16, 2013

Status Verified

May 1, 2013

Enrollment Period

2 years

First QC Date

May 8, 2013

Last Update Submit

May 13, 2013

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosisMesenchymal stem cells

Outcome Measures

Primary Outcomes (2)

  • Safety

    Incidence and severity of adverse events in MSC treatment group compared to placebo group.

    24 weeks from the first infusion

  • efficacy

    total number of contrast-enhancing lesions (GEL) at MRI scan

    24 weeks from the first infusion

Secondary Outcomes (5)

  • Efficacy

    48 weeks from the first infusion

  • Efficacy

    24 weeks form the first infusion

  • Efficacy

    48 weeks from the first infusion

  • Efficacy

    48 weeks from the first infusion

  • Efficacy

    48 weeks from the first infusion

Study Arms (2)

Autologous Mesenchymal Stem Cells

EXPERIMENTAL

At week 0 a single infusion of either ex-vivo expanded autologous MSC or suspension media will be administered intravenously at a dose of 1-2 x 1000000 MSC/Kg body weight. At week 24, another infusion will be performed for cross-over re-treatment: at week 24 treatments will be reversed compared to week 0

Biological: Autologous Mesenchymal Stem Cells

Suspension media

PLACEBO COMPARATOR

At week 0 a single infusion of either ex-vivo expanded autologous MSC or suspension media will be administered intravenously at a dose of 1-2 x 1000000 MSC/Kg body weight. At week 24, another infusion will be performed for cross-over re-treatment: at week 24 treatments will be reversed compared to week 0

Interventions

Autologous Mesenchymal Stem CellsBIOLOGICAL

Single dose of 1-2 x 1000000 cells/Kg body weight

Autologous Mesenchymal Stem Cells

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- 1. Diagnosis of MS
  • a. Relapsing remitting MS (RRMS) not responding to at least a year of attempted therapy with one or more of the approved therapies (beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, fingolimod) as evidenced by one or more of the following: i. ≥1 clinically documented relapse in past 12 months
  • ii. ≥2 clinically documented relapses in last 24 months
  • iii. ≥1 GEL at MRI performed within the last 12 months
  • b. Secondary progressive MS (SPMS) not responding to at least a year of attempted therapy with one or more of the approved therapies (beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, fingolimod) as evidenced by both:
  • i. an increase of ≥1 point of the expanded disability status scale (EDSS) (if at randomization EDSS ≤ 5.0) or 0.5 EDSS point (if at randomization EDSS ≥ 5.5) in the last 12 months
  • ii. ≥1 clinically documented relapse or ≥ 1 GEL at MRI within the last twelve months.
  • c. Primary progressive MS (PPMS) patients with all the following features:
  • i. an increase of ≥1 EDSS point (if at randomization EDSS ≤ 5.0) or 0.5 EDSS point (if at randomization EDSS ≥5.5), in the last twelve months
  • ii. ≥ 1 GEL at MRI performed within the last 12 months
  • iii. positive cerebrospinal fluid (CSF) (oligoclonal banding
  • \. Age 18 to 50 years
  • \. Disease duration 2 to 10 years (included)
  • \. EDSS 3.0 to 6.5

You may not qualify if:

  • \. Any active or chronic infection including infection with HIV1-2 or chronic Hepatitis B or Hepatitis C
  • \. Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization
  • \. Treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization
  • \. Treatment with corticosteroids within the 30 days prior to randomization
  • \. Relapse occurred during the 60 days prior to randomization
  • \. Previous history of a malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year
  • \. Severely limited life expectancy by another co-morbid illness
  • \. History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts
  • \. Pregnancy or risk or pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study)
  • \. eGFR \< 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination.
  • \. Inability to give written informed consent in accordance with research ethics board guidelines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Genova

Genova, Genova, 16132, Italy

RECRUITING

Related Publications (2)

  • Thebault S, Reaume M, Marrie RA, Marriott JJ, Furlan R, Laroni A, Booth RA, Uccelli A, Freedman MS. High or increasing serum NfL is predictive of impending multiple sclerosis relapses. Mult Scler Relat Disord. 2022 Mar;59:103535. doi: 10.1016/j.msard.2022.103535. Epub 2022 Jan 19.

    PMID: 35078125DERIVED

  • Uccelli A, Laroni A, Brundin L, Clanet M, Fernandez O, Nabavi SM, Muraro PA, Oliveri RS, Radue EW, Sellner J, Soelberg Sorensen P, Sormani MP, Wuerfel JT, Battaglia MA, Freedman MS; MESEMS study group. MEsenchymal StEm cells for Multiple Sclerosis (MESEMS): a randomized, double blind, cross-over phase I/II clinical trial with autologous mesenchymal stem cells for the therapy of multiple sclerosis. Trials. 2019 May 9;20(1):263. doi: 10.1186/s13063-019-3346-z.

    PMID: 31072380DERIVED

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

  • Giancarlo Comi, MD

    Ospedale San Raffaele

    PRINCIPAL INVESTIGATOR

  • Bruno Bonetti, MD

    Azienda Ospedaliera Universitaria Integrata di Verona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Uccelli, MD

CONTACT

+390103537028MESEMS@unige.it

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 8, 2013

First Posted

May 16, 2013

Study Start

July 1, 2012

Primary Completion

July 1, 2014

Study Completion

September 1, 2014

Last Updated

May 16, 2013

Record last verified: 2013-05

Locations

IT(1)