MEsenchymal StEm Cells for Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02403947
• Date of registration: 09/03/2015
• Prospective Registration: No
• Primary sponsor: University Hospital, Toulouse
• Public title: MEsenchymal StEm Cells for Multiple Sclerosis MESEMS
• Scientific title: Treatment of Multiple Sclerosis With Mesenchymal Stem Cells: Phase I/II Study
• Date of first enrolment: February 2015
• Target sample size: 1
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02403947
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

France

Contacts

• Name: Clanet Michel, MD,PhD
• Affiliation: Neurology Department of Purpan Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age 18 to 50 years

- Disease duration 2 to 10 years (included)

- 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:

- more or egal 1 clinically documented relapse in past 12 months

- more or egal 2 clinically documented relapses in last 24 months

- more or egal 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::

- With more or egal 1 clinically documented relapse in the last twelve months

- Without on-going relapses, but with more or egal 1 GEL at MRI performed within the
last 12 months.

Primary progressive MS (PPMS) patients with all the following features:

- an increase ofmore or egal 1 EDSS point (if at inclusion EDSS inferior or egal 5.0) or
0.5 EDSS point (if at inclusion EDSS more or egal 5.5), in the last twelve months

- more or egal 1 GEL at MRI performed within the last 12 months

- Positive cerebrospinal fluid (CSF) (oligoclonal banding).

- EDSS (Expanded Disability Status Scale) 3.0 to 6.5

- Women of childbearing age with an effective contraception.

Exclusion Criteria:

- RRMS not fulfilling inclusion criteria

- SPMS not fulfilling inclusion criteria

- PPMS not fulfilling inclusion criteria

- Inferior to 3 months since treatment with any immunosuppressive therapy including
natalizumab and fingolimod

- Inferior or egal to 1 month since last treatment with interferon-beta or glatiramer
acetate

- Corticosteroid treatment Inferior or egal to 30 days

- Relapse inferior or egal to 60 days

- Any active or chronic infection including infection with HIV1-2 (Human
Immunodeficiency Virus 2) or HTLV I-II (Human T-lymphotropic virus I-II) or Syphilis
or chronic Hepatitis B or Hepatitis C inferior to 1 month

- 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 (estimated Glomerular Filtration Rate ) inferior to 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.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Suspension media

Drug: Mesenchymal stem cells

Primary Outcome(s)

efficacy: number of contrast-enhancing lesions (GEL) at MRI scan [Time Frame: 24 weeks from the first infusion]

Safety of MSCs infusion, number, timeframe of occurrence and severity of Adverse Events [Time Frame: 24 weeks from the first infusion]

Secondary Outcome(s)

Efficacy: Number of relapses [Time Frame: 24 weeks from the first infusion]

Efficacy: Time to sustained progression of disability [Time Frame: 24 weeks from the first infusion]

Efficacy of the experimental treatment in term of combined MRI activity [Time Frame: 48 weeks from the first infusion]

Efficacy assessed by combined unique MRI activity, volume of GEL and volume of BH [Time Frame: 48 weeks from the first infusion]

Efficacy assessed by combined unique MRI activity, volume of GEL, and volume of BH [Time Frame: 24 weeks from the first infusion]

Secondary ID(s)

12 394 03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors