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Mesenchymal Stem Cells for Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT01730547
Recruitment Status : Unknown
Verified January 2015 by Ellen Iacobaeus, Karolinska Institutet.
Recruitment status was:  Recruiting
First Posted : November 21, 2012
Last Update Posted : January 15, 2015
Sponsor:
Information provided by (Responsible Party):
Ellen Iacobaeus, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE November 9, 2012
First Posted Date  ICMJE November 21, 2012
Last Update Posted Date January 15, 2015
Study Start Date  ICMJE February 2013
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2012)
To assess the safety of IV therapy with autologous Mesenchymal Stem Cells (MSCs) in MS patients. [ Time Frame: 48 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01730547 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2012)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mesenchymal Stem Cells for Multiple Sclerosis
Official Title  ICMJE Phase 1/2 Clinical Trial With Autologous Mesenchymal Stem Cells for the Therapy of Multiple Sclerosis
Brief Summary The aim of the study is to evaluate the safety and efficacy of autologous mesenchymal stromal cells as treatment for Multiple Sclerosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Biological: Autologous mesenchymal stem cells
Study Arms  ICMJE
  • 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
Publications * Uccelli A, Laroni A, Brundin L, Clanet M, Fernandez O, Nabavi SM, Muraro PA, Oliveri RS, Radue EW, Sellner J, Soelberg Sorensen P, Sormani MP, Wuerfel JT, Battaglia MA, Freedman MS; MESEMS study group. MEsenchymal StEm cells for Multiple Sclerosis (MESEMS): a randomized, double blind, cross-over phase I/II clinical trial with autologous mesenchymal stem cells for the therapy of multiple sclerosis. Trials. 2019 May 9;20(1):263. doi: 10.1186/s13063-019-3346-z.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 20, 2012)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01730547
Other Study ID Numbers  ICMJE MSC-MS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ellen Iacobaeus, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Karolinska Institutet
Verification Date January 2015

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