NCT01606215

Brief Summary

This is a randomised, double-blind crossover study to study the effect of intravenous treatment with autologous (derived from the individuals themselves) mesenchymal stem cells (MSCs) in patients with multiple sclerosis (MS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for phase_1 multiple-sclerosis

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_1 multiple-sclerosis

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

May 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

January 14, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

6.6 years

First QC Date

May 21, 2012

Results QC Date

February 10, 2021

Last Update Submit

January 10, 2025

Conditions

Multiple Sclerosis

Keywords

multiple sclerosismesenchymal stem cellsbone marrowrapidly evolving

Outcome Measures

Primary Outcomes (2)

  • Number of Adverse Events Assessed by CTCAE v4.0

    The number of adverse events before crossover in the stem cell treatment group compared to the placebo group over the first 24 weeks (please refer to period 1 of the participant flow).

    24 weeks from baseline

  • Number of GELs Newly Appearing at Weeks 4, 12 and 24 After MSC Therapy in the First 24 Weeks of Trial

    Where GELs stands for gadolinium enhancing lesions and MSC for Mesenchymal Stem Cell. This was to evaluate the efficacy of autologous mesenchymal stem cells in MS patients, quantified by the reduction in the number of new gadolinium-enhancing lesions counted on MRI scans over 24 weeks and the total number of GELs counted over months 1, 3 and 6 will be compared between treatment groups.

    Up to 24 weeks

Secondary Outcomes (5)

  • Number of Newly Appearing GELs Over Months 1, 3 and 6 Will be Compared Between Treatment Groups.

    Months 1, 3 and 6

  • Comparison of Contrast Enhancing Lesions Between Treatment Periods Following Crossover

    Months 6-12

  • Combined Unique MRI Activity

    Weeks 4, 12 and 24

  • Relapses

    6 months

  • Progression of Disability

    6 months

Study Arms (2)

mesenchymal stem cells

EXPERIMENTAL

1-2 x106 MSCs/kg administered at Week 0

Drug: Mesenchymal stem cells

Placebo

SHAM COMPARATOR

Suspension media administered at Week 0

Drug: Placebo

Interventions

Mesenchymal stem cellsDRUG

1.0-2.0 million cells/kg body weight

Also known as: Mesenchymal stromal cells
mesenchymal stem cells
PlaceboDRUG

Placebo

Also known as: Sham
Placebo

Eligibility Criteria

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

You may qualify if:

  • Patients with clinically and radiologically active multiple sclerosis as defined by:
  • Diagnosis of MS:
  • Relapsing remitting MS (RRMS): ≥ 1 moderate-severe relapse and ≥1 GEL in past 18 months or ≥ 1 moderate-severe relapse and ≥1 new T2 lesion in past 18 months.
  • Secondary progressive MS (SPMS) with an increase of ≥ 1 EDSS point (if baseline EDSS ≤ 5) or 0.5 EDSS point (if baseline EDSS ≥ 5.5), in the previous 18 months and ≥ 1 GEL in past 18 months or ≥ 1 moderate-severe relapse and ≥1 new T2 lesion in past 18 months.
  • Primary progressive MS (PPMS) patients with positive oligoclonal bands (OCBs) in the cerebrospinal fluid (CSF) and an increase of ≥ 1 EDSS point (if baseline EDSS is ≤ 5.0) or 0.5 EDSS point (if baseline EDSS is ≥ 5.5), or quantifiable, objective evidence of equivalent progression in the previous 18 months and ≥ 1 GEL in past 18 months or ≥ 1 new T2 lesion in past 18 months.
  • Age 18 to 50 years.
  • Disease duration 2 to 10 years from diagnosis (inclusive).
  • Expanded Disability Status Scale (EDSS) 2.0 to 6.5 at screening evaluation.
  • ≥ 1 GEL on MRI within 6 months prior to harvesting.
  • Adequate culture of a subject's MSCs and their release for clinical use.

You may not qualify if:

  • RRMS without at least one severe relapse in the previous 18 months or without at least one GEL or one new T2 in the previous 18 months.
  • SPMS without relapses and without new lesions (GEL or T2 positive) at MRI in the last 18 months.
  • PPMS without positive CSF OCBs or without a GEL or new T2 lesion in the previous 18 months.
  • No gadolinium enhancing lesion(s) in the 3 months prior to bone marrow harvesting.
  • Failure of bone marrow (BM) sample to generate MSCs suitable for clinical use within a specified time frame (4 weeks).
  • Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the last 3 months.
  • Treatment with interferon-beta or glatiramer acetate within the last 1 month.
  • Treatment with alemtuzumab (campath-1H) within the last 2 years.
  • Prior treatment with total lymphoid irradiation and autologous or allogeneic hematopoietic stem cell transplantation.
  • Participation in clinical trials of any experimental drugs in the 6 months before study entry.
  • Corticosteroid treatment in the last 30 days.
  • Presence of any active or chronic infection.
  • Previous history of a malignancy other than basal cell carcinoma of the skin and carcinoma in situ that has been in remission for more than one year.
  • Severely limited life expectancy by any other co-morbid illness.
  • Abnormal blood counts, a history of myelodysplasia or other cytopenia.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 0NN, United Kingdom

Location

Related Publications (1)

  • 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: 31072380RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Professor Paolo Muraro
Organization
Imperial College London
p.muraro@imperial.ac.uk
02075946670

Study Officials

  • Paolo A Muraro, MD PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

Study Record Dates

First Submitted

May 21, 2012

First Posted

May 25, 2012

Study Start

January 1, 2013

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

January 14, 2025

Results First Posted

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)