Mesenchymal Stem Cells for Multiple Sclerosis

This study is currently recruiting participants.
Verified February 2013 by Karolinska Institutet
Sponsor:
Information provided by (Responsible Party):
Ellen Iacobaeus, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01730547
First received: November 9, 2012
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

The aim of the study is to evaluate the safety and efficacy of autologous mesenchymal stromal cells as treatment for Multiple Sclerosis.


Condition Intervention Phase
Multiple Sclerosis
Biological: Autologous mesenchymal stem cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1/2 Clinical Trial With Autologous Mesenchymal Stem Cells for the Therapy of Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • To assess the safety of IV therapy with autologous Mesenchymal Stem Cells (MSCs) in MS patients. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    The primary objective of the study is to assess the safety of IV therapy with autologous MSCs in MS. Number of participants with adverse events will be documented at week 0,4,8,12,16,20,24,28,32,36,40,44,48 post treatment. Co-primary objective of the study is to evaluate the activity of autologous MSCS in MS patients, in terms of reduction as compared to placebo in the total number of contrast-enhancing lesions (GEL) at MRI acquired on conventional 1,5 T MRI scans over 24 weeks.


Secondary Outcome Measures:
  • To gather preliminary information of the efficacy of the experimental treatment in terms of combined MRI activity and clinical efficacy (incidence of relapses and disability progression). [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: February 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Early treatment with mesenchymal stem cells Biological: Autologous mesenchymal stem cells
Active Comparator: Delayed treatment with mesenchymal stem cells Biological: Autologous mesenchymal stem cells

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of MS

    a. 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 ii. ≥2 clinically documented relapses in last 24 months iii. ≥1 GEL at MRI performed within the last 12 months

    b. 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: i. 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 12 months ii. ≥1 clinically documented relapse or ≥ 1 GEL at MRI within the last twelve months.

    c. Primary progressive MS (PPMS) patients with all the following features: i. 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 ii. ≥ 1 GEL at MRI performed within the last 12 months iii. 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

Exclusion Criteria:

  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
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730547

Contacts
Contact: Lou Brundin, MD.Professor +46 7074848505 ext +46 lou.brundin@karolinska.se
Contact: Ellen Iacobaeus, MD.PhD +46 707433644 ext +46 ellen.iacobaeus@karolinska.se

Locations
Sweden
Karolinska Institute, Karolinska University Hospital Solna Recruiting
Stockholm, Sweden, 171 76
Principal Investigator: Lou Brundin, MD. Professor         
Sub-Investigator: Ellen Iacobaeus, MD. PhD         
Sub-Investigator: Katarina Le Blanc, MD. Professor         
Sponsors and Collaborators
Karolinska Institutet
  More Information

No publications provided

Responsible Party: Ellen Iacobaeus, MD.PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01730547     History of Changes
Other Study ID Numbers: MSC-MS
Study First Received: November 9, 2012
Last Updated: February 11, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Karolinska Institutet:
Mesenchymal stem cells
Multiple Sclerosis
Autoimmune diseases

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014