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CompletedNCT03778333Updated Jun 1, 2023

Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden

A Phase 1 interventional study of Autologous mesenchymal stem cells in Autologous Mesenchymal Stem Cells and Multiple Sclerosis, sponsored by Karolinska Institutet. Completed at 2 sites in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-06-01.

Sponsored by Karolinska Institutet · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Dec 2012, registered Jan 2015).
Phase
Phase 1
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Autologous Mesenchymal Stem Cells
  • Multiple Sclerosis

Keywords

  • Mesenchymal Stem Cells
  • Multiple Sclerosis
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 7 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Diagnosis of MS

    1. 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.
    2. 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.
    3. 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.
  2. Age_ 18-65 years
  3. Disease duration: 2-20 years
  4. EDSS 3,0-7,0

Exclusion criteria

Exclusion Criteria:

  1. Subtype of MS not fulfilling inclusion criteria
  2. Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization
  3. Treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization
  4. Treatment with corticosteroids within the 30 days prior to randomization
  5. Relapse occurred during the 60 days prior to randomization
  6. 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
  7. Severely limited life expectancy by another co-morbid illness
  8. Active or chronic severe infection.
  9. History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts
  10. Pregnancy or risk or pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study)
  11. eGFR \< 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination.
  12. Inability to give written informed consent in accordance with research ethics board guidelines
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Open label single arm study

    All patients will be treated with 1 single dose of IV infusion of autologous bone-marrow derived mesenchymal stem cells (1-2 million cells/kg body weight) and their therapeutic response will be followed over 48 weeks.

    Biological: Autologous mesenchymal stem cells

Interventions

  • BiologicalAutologous mesenchymal stem cells

    IV therapy with autologous bone-marrow derived mesenchymal stem cells

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 48 weeks

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

    Brain MRI examination

    Time frame: 48 weeks

Secondary outcomes

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

    EDSS assessed by neurologist.

    Time frame: 48 weeks

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

    Peripheral blood samples.

    Time frame: 24 weeks

07

Study locations

2 sites
  • Karolinska Institute, Karolinska University Hospital Solna
    Stockholm, 171 76, Sweden
  • Karolinska Institute, Karolinska University Hospital
    Stockholm, 17176, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03778333
Lead sponsor
Karolinska Institutet
Responsible party
Lou Brundin (MD, PhD, Karolinska Institutet) — Principal investigator
First posted
Dec 19, 2018
Start date
Dec 1, 2012
Primary completion
Dec 2016
Completion
Dec 31, 2016
Last update
Jun 1, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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