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ClinicalTrials.gov Identifier: NCT01730547
Recruitment Status : Unknown
Verified January 2015 by Ellen Iacobaeus, Karolinska Institutet. Recruitment status was: Recruiting
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.
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 ]
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Ages Eligible for Study:
18 Years to 50 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)
Age 18 to 50 years
Disease duration 2 to 10 years (included)
EDSS 3.0 to 6.5
RRMS not fulfilling inclusion criteria
SPMS not fulfilling inclusion criteria
PPMS not fulfilling inclusion criteria
Any active or chronic infection including infection with HIV1-2 or chronic Hepatitis B or Hepatitis C
Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization
Treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization
Treatment with corticosteroids within the 30 days prior to randomization
Relapse occurred during the 60 days prior to randomization
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
Severely limited life expectancy by another co-morbid illness
History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts
Pregnancy or risk or pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study)
eGFR < 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination.
Inability to give written informed consent in accordance with research ethics board guidelines