ID

37019

Beschrijving

Autologous Mesenchymal Stromal Cells for Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT02495766

Link

https://clinicaltrials.gov/show/NCT02495766

Trefwoorden

Versies (1)
  1. 30-06-19 30-06-19 -
Houder van rechten

See clinicaltrials.gov

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30 juni 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Relapsing-Remitting Multiple Sclerosis NCT02495766

Engels

Eligibility Relapsing-Remitting Multiple Sclerosis NCT02495766

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients between 18 and 60 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients with ms
Beschrijving

Multiple Sclerosis

Datatype

boolean

Alias
UMLS CUI [1]
C0026769
relapsing-remitting or secondary progressive ms
Beschrijving

Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive

Datatype

boolean

Alias
UMLS CUI [1]
C0751967
UMLS CUI [2]
C0751965
patients to whom are not indicated or are not in a position to initiate treatment with disease-modifying drugs
Beschrijving

Indication Absent Biological Response Modifier Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0005527
expanded disability status scale (edds) score <6.5
Beschrijving

EDSS

Datatype

boolean

Alias
UMLS CUI [1]
C0451246
nine t2 lesions at least
Beschrijving

Lesion T2 Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C3472340
UMLS CUI [1,3]
C1265611
active multiple sclerosis as defined either by 1 outbreak in the last year or at least one gadolinium-enhancing lesion in the last 6 months
Beschrijving

Multiple Sclerosis | Event Quantity Past Year | Gadolinium-Enhancing Lesion Quantity

Datatype

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2,1]
C0441471
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C4086728
UMLS CUI [3,1]
C1333400
UMLS CUI [3,2]
C1265611
signed informed consent form
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
interferon beta or glatiramer acetate 3 months prior the screening
Beschrijving

Interferon-beta | glatiramer acetate

Datatype

boolean

Alias
UMLS CUI [1]
C0015980
UMLS CUI [2]
C0289884
natalizumab or fingolimod in the 6 months prior the screening
Beschrijving

natalizumab | fingolimod

Datatype

boolean

Alias
UMLS CUI [1]
C1172734
UMLS CUI [2]
C1699926
mitoxantrone, cyclophosphamide or other immunosuppressive therapy at any time
Beschrijving

Mitoxantrone | Cyclophosphamide | Therapeutic immunosuppression

Datatype

boolean

Alias
UMLS CUI [1]
C0026259
UMLS CUI [2]
C0010583
UMLS CUI [3]
C0021079
has received an experimental treatment within 3 months prior the screening
Beschrijving

Therapy, Investigational

Datatype

boolean

Alias
UMLS CUI [1]
C0949266
ms outbreak within the 4 weeks prior the randomization
Beschrijving

Multiple Sclerosis Event Recent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C0332185
serum creatinine> 2.0 mg/dl
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
infectious disease active or uncontrolled
Beschrijving

Communicable Disease | Communicable Disease Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
fertile patients who are not using a suitable method of contraception
Beschrijving

Patients Fertile | Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0015895
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0332197
pregnant or lactating woman
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
immunodeficiency
Beschrijving

Immunodeficiency

Datatype

boolean

Alias
UMLS CUI [1]
C0021051
positive serology to hiv, hepatitis b, hepatitis c or syphilis
Beschrijving

HIV Seropositivity | Hepatitis B Seropositive | Hepatitis C Seropositive | Syphilis Seropositive

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0019163
UMLS CUI [2,2]
C0521143
UMLS CUI [3,1]
C0019196
UMLS CUI [3,2]
C0521143
UMLS CUI [4,1]
C0039128
UMLS CUI [4,2]
C0521143
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Similar models

Eligibility Relapsing-Remitting Multiple Sclerosis NCT02495766

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients between 18 and 60 years of age
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis
Item
patients with ms
boolean
C0026769 (UMLS CUI [1])
Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive
Item
relapsing-remitting or secondary progressive ms
boolean
C0751967 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
Indication Absent Biological Response Modifier Therapy
Item
patients to whom are not indicated or are not in a position to initiate treatment with disease-modifying drugs
boolean
C3146298 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0005527 (UMLS CUI [1,3])
EDSS
Item
expanded disability status scale (edds) score <6.5
boolean
C0451246 (UMLS CUI [1])
Lesion T2 Quantity
Item
nine t2 lesions at least
boolean
C0221198 (UMLS CUI [1,1])
C3472340 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Multiple Sclerosis | Event Quantity Past Year | Gadolinium-Enhancing Lesion Quantity
Item
active multiple sclerosis as defined either by 1 outbreak in the last year or at least one gadolinium-enhancing lesion in the last 6 months
boolean
C0026769 (UMLS CUI [1])
C0441471 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C4086728 (UMLS CUI [2,3])
C1333400 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Informed Consent
Item
signed informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Interferon-beta | glatiramer acetate
Item
interferon beta or glatiramer acetate 3 months prior the screening
boolean
C0015980 (UMLS CUI [1])
C0289884 (UMLS CUI [2])
natalizumab | fingolimod
Item
natalizumab or fingolimod in the 6 months prior the screening
boolean
C1172734 (UMLS CUI [1])
C1699926 (UMLS CUI [2])
Mitoxantrone | Cyclophosphamide | Therapeutic immunosuppression
Item
mitoxantrone, cyclophosphamide or other immunosuppressive therapy at any time
boolean
C0026259 (UMLS CUI [1])
C0010583 (UMLS CUI [2])
C0021079 (UMLS CUI [3])
Therapy, Investigational
Item
has received an experimental treatment within 3 months prior the screening
boolean
C0949266 (UMLS CUI [1])
Multiple Sclerosis Event Recent
Item
ms outbreak within the 4 weeks prior the randomization
boolean
C0026769 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Creatinine measurement, serum
Item
serum creatinine> 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Communicable Disease | Communicable Disease Uncontrolled
Item
infectious disease active or uncontrolled
boolean
C0009450 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Patients Fertile | Contraceptive methods Absent
Item
fertile patients who are not using a suitable method of contraception
boolean
C0030705 (UMLS CUI [1,1])
C0015895 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Immunodeficiency
Item
immunodeficiency
boolean
C0021051 (UMLS CUI [1])
HIV Seropositivity | Hepatitis B Seropositive | Hepatitis C Seropositive | Syphilis Seropositive
Item
positive serology to hiv, hepatitis b, hepatitis c or syphilis
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2,1])
C0521143 (UMLS CUI [2,2])
C0019196 (UMLS CUI [3,1])
C0521143 (UMLS CUI [3,2])
C0039128 (UMLS CUI [4,1])
C0521143 (UMLS CUI [4,2])
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