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Table 3 Inclusion criteria of the MESEMS trial

From: 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

 

Italy

Spain–Andalusia

Copenhagen

London

Stockholm

Toulouse

Spain–Catalonia

Salzburg

Tehran

RRMS with:

≥ 1 clinically documented relapse in past 12 months

x

x

See below

See below

x

x

x

x

 

≥ 2 clinically documented relapses in last 24 months

x

x

x

x

x

x

x

≥ 1 GEL at MRI performed within the last 12 months or new T2 lesion at MRI performed within the last 12 months compared to a previous MRI performed within the last 12 months.

x

x

x

x

x

x

x

  

London: ≥ 1 moderate-severe relapse AND (1 or more GELs in past 18 months OR ≥ 1 new T2 lesion). PLUS: ≥ 1 on MRI within 3 months prior to harvesting

  

Copenhagen ≥ 1 moderate-severe relapse in past 18 months OR ≥ 1 GEL (double-triple Gad) OR ≥ 1 new T2

SPMS with:

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 AND ≥ 1 clinically documented relapse or ≥ 1 GEL at MRI within the last 12 months

x

x

No SPMS

See below

x

x

x

x

x

Other (specify)

 

London: Changes in EDSS relate to previous 18 months AND 1(+) GELs in last 18 months or require SPMS with 1(+) relapses and 1(+) T2 lesions in past 18 months

PPMS with:

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

x

x

No PPMS

See below

x

x

x

x

x

AND ≥ 1 GEL at MRI performed within the last 12 months

x

x

x

x

x

x

x

AND Positive cerebrospinal fluid (CSF) (oligoclonal banding)

x

x

x

x

x

x

x

  

London: EDSS changes, GELs, or T2 lesions over last 18 months. PLUS: ≥ 1 on MRI within 3 months prior to harvesting