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Trial record 3 of 76 for:    stem cell multiple sclerosis

Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden

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ClinicalTrials.gov Identifier: NCT03778333
Recruitment Status : Completed
First Posted : December 18, 2018
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Ellen Iacobaeus, Karolinska Institutet

Brief 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.

Condition or disease Intervention/treatment Phase
Autologous Mesenchymal Stem Cells Multiple Sclerosis Biological: Autologous mesenchymal stem cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label phase 1, single-center, pre-post comparison study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden
Actual Study Start Date : December 1, 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
IV therapy with autologous bone-marrow derived mesenchymal stem cells




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778333


Locations
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Sweden
Karolinska Institute, Karolinska University Hospital Solna
Stockholm, Sweden, 171 76
Karolinska Institute, Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet

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Responsible Party: Ellen Iacobaeus, Principal investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03778333     History of Changes
Other Study ID Numbers: MSC-progressive MS
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ellen Iacobaeus, Karolinska Institutet:
Mesenchymal Stem Cells
Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases