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

November 9, 2012
February 11, 2013
February 2013
December 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01730547 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Mesenchymal Stem Cells for Multiple Sclerosis
Phase 1/2 Clinical Trial With Autologous Mesenchymal Stem Cells for the Therapy of Multiple Sclerosis

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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis
Biological: Autologous mesenchymal stem cells
  • Active Comparator: Early treatment with mesenchymal stem cells
    Intervention: Biological: Autologous mesenchymal stem cells
  • Active Comparator: Delayed treatment with mesenchymal stem cells
    Intervention: Biological: Autologous mesenchymal stem cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
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
Sweden
 
NCT01730547
MSC-MS
Yes
Ellen Iacobaeus, Karolinska Institutet
Karolinska Institutet
Not Provided
Not Provided
Karolinska Institutet
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP