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Multiple SclerosisPhase 1/2MESEMSNCT01854957

MEsenchymal StEm Cells for Multiple Sclerosis

A Phase 1/2 study testing Autologous Mesenchymal Stem Cells in people with Multiple Sclerosis, run by Antonio Uccelli at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Autologous Mesenchymal Stem Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteItaly
Study dates
Jul 2012to Sep 2014
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 1. Diagnosis of MS
  • 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
  • ≥2 clinically documented relapses in last 24 months
  • ≥1 GEL at MRI performed within the last 12 months
  • 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:
  • 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
Show all 14Show fewer
  • ≥1 clinically documented relapse or ≥ 1 GEL at MRI within the last twelve months.
  • Primary progressive MS (PPMS) patients with all the following features:
  • 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
  • ≥ 1 GEL at MRI performed within the last 12 months
  • positive cerebrospinal fluid (CSF) (oligoclonal banding
  • 2. Age 18 to 50 years
  • 3. Disease duration 2 to 10 years (included)
  • 4. EDSS 3.0 to 6.5

Who cannot join

  • 1. RRMS not fulfilling inclusion criteria
  • 2. SPMS not fulfilling inclusion criteria
  • 3. PPMS not fulfilling inclusion criteria
  • 4. Any active or chronic infection including infection with HIV1-2 or chronic Hepatitis B or Hepatitis C
  • 5. Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization
  • 6. Treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization
Show all 14Show fewer
  • 7. Treatment with corticosteroids within the 30 days prior to randomization
  • 8. Relapse occurred during the 60 days prior to randomization
  • 9. 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
  • 10. Severely limited life expectancy by another co-morbid illness
  • 11. History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts
  • 12. Pregnancy or risk or pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study)
  • 13. eGFR < 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination.
  • 14. Inability to give written informed consent in accordance with research ethics board guidelines

Trial locations and contacts

1 site in 1 country.

Antonio Uccelli, MD contact

+390103537028

MESEMS@unige.it

Italy1 site, 1 recruiting

  • University of Genova

    Genova, Genova, 16132

    Antonio Uccelli, MD, PhD

    Recruiting

Other trials in Italy

About this study

Official title: MEsenchymal StEm Cells for Multiple Sclerosis (MESEMS) Phase I-II Clinical Trial With Autologous Mesenchymal Stem Cells (MSCs) for the Therapy of Multiple Sclerosis

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.

Read the detailed description

The mechanism of action of MSC relies on their ability to modulate pathogenic immune responses and provide neuroprotection through the release of anti-apoptotic, anti-oxidant and trophic factors as demonstrated by in vitro and in vivo preclinical studies.

Patients will be randomized to receive immediate vs. delayed treatment with either a dose equal to 1-2 millions/kg of body weight of autologous MSC, or equivalent volume of suspension media at baseline. At 6 months treatments will be reversed.

The primary outcome of this study is to evaluate

  • treatment's safety within one year from MSC administration by measuring the the number, time-frame and severity of adverse event and
  • treatment's activity in terms of reduction in the total number of contrast-gadolinium enhancing lesions (GEL) by magnetic resonance imaging (MRI) scans.

Secondary outcomes are to gain preliminary information on the efficacy of the experimental treatment in terms of combined MRI activity and clinical efficacy (incidence of relapses and disability progression).

Being tested
Autologous Mesenchymal Stem Cells
Keywords
Multiple sclerosis, Mesenchymal stem cells
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous Mesenchymal Stem CellsBiological

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

Study groups in NCT01854957
Study groupRoleWhat they receive
Autologous Mesenchymal Stem CellsExperimentalAt 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
Receives: Biological: Autologous Mesenchymal Stem Cells
Suspension mediaPlacebo comparatorAt 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

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

    Measured: 24 weeks from the first infusion

  2. efficacy

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

    Measured: 24 weeks from the first infusion

Secondary outcomes (5)

  1. Efficacy

    Number of GEL counted over week 28, 36 and 48 compared with the number of GEL counted over 4, 12 and 24 weeks.

    Measured: 48 weeks from the first infusion

  2. Efficacy

    Combined unique MRI activity (number of new or enlarging T2, or enhancing or re-enhancing lesions), volume of GEL and volume of black holes (BH) over 4, 12, 24 weeks compared between treatment groups.

    Measured: 24 weeks form the first infusion

  3. Efficacy

    Combined unique MRI activity, volume of GEL and volume of BH over week 28, 36 and 48 compared with the same outcomes over 4, 12 and 24 weeks.

    Measured: 48 weeks from the first infusion

  4. Efficacy

    Number of relapses in MSC treatment group vs. placebo group in the first 24 weeks and after cross-over re-treatment in the two groups.

    Measured: 48 weeks from the first infusion

  5. Efficacy

    Time to sustained progression of disability and proportion of progression-free patients compared between treatment groups during the first 24 weeks and after cross-over

    Measured: 48 weeks from the first infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2013 (estimated)
  2. Study startJul 2012
  3. Primary completionJul 2014 (estimated)
  4. Study completionSep 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01854957
Sponsor's protocol ID
MESEMS
Other IDs
2011-001295-19
Acronym
MESEMS
Status last verified
May 2013
First submitted
8 May 2013
Last updated
16 May 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 35078125

  • 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.

    PubMed 31072380

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Autologous Mesenchymal Stem Cells in people with Multiple Sclerosis, run by Antonio Uccelli at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Antonio Uccelli, MD (+390103537028, MESEMS@unige.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: 24 weeks from the first infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01854957, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2013.

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