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Completed

NCT Number: NCT03778333

Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden

To assess the safety of a single dose of IV infusion of bone-marrow derived autologous Mesenchymal Stem Cells (MSCs) in Multiple Sclerosis (MS) with progressive disease status.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of MS
  • Active relapsing remitting MS (RRMS) as evidenced by presence of ≥ 1 clinically documented relapse in the past 12 months or ≥2 clinically documented relapses in the last 24 months.
  • Secondary progressive MS with clinical progression as evidenced by an increase of 1 EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year or evidenced by ≥1 relapse or ≥ GEL at MRI performed within the last year.
  • Primary progressive MS with clinical progression as evidenced by an increase of 1 EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year.
  • Age_ 18-65 years
  • Disease duration: 2-20 years
  • EDSS 3,0-7,0

Exclusion criteria

  • Subtype of MS not fulfilling inclusion criteria
  • 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
  • Active or chronic severe infection.
  • 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

Treatment and study plan

Autologous mesenchymal stem cells

Biological

IV therapy with autologous bone-marrow derived mesenchymal stem cells

Primary outcomes

  1. To evaluate number of participants with an adverse event related to the treatment.

    Time frame: 48 weeks

    Adverse events is defined as any untoward or undesirable medical occurence in the form of signs, symptoms, abnormal findings or diseases that emerge during the study period, regardless of causal relationship to the study drug.

  2. To evaluate effects on MS disease activity measured by cumulative number of MRI T2 lesions.

    Time frame: 48 weeks

    Brain MRI examination

Secondary outcomes

  1. To evaluate effects on MS disease activity measured by change in EDSS (expanded disability status scale).

    Time frame: 48 weeks

    EDSS assessed by neurologist.

  2. To evaluate effect on peripheral blood immune cell populations.

    Time frame: 24 weeks

    Peripheral blood samples.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 19, 2018
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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