ID

38076

Beschreibung

This is a Phase 1, open label, dose escalation, multi-center clinical trial of Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells (hMSCs) for the treatment of Acute Respiratory Distress Syndrome (ARDS). The purpose of this study is to assess the safety of hMSCs in patients with ARDS. The primary objective of this study is to assess the safety of intravenous infusion of Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells (hMSCs) in patients with ARDS.

Stichworte

Versionen (1)
  1. 15.09.19 15.09.19 -
Rechteinhaber

Michael A. Matthay

Hochgeladen am

15. September 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Stemcells for Acute Respiratory Distress Syndrome NCT01775774

Englisch

Eligibility Criteria

1 Formulare  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Does the participant have a need for positive pressure ventilation by an endotracheal or tracheal tube with a PaO2/FiO2 ratio < 200 with at least 8 cm H2O positive end-expiratory airway pressure (PEEP)?
Beschreibung

Need for PEEP ventilation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0032740
UMLS CUI [1,3]
C0336630
UMLS CUI [1,4]
C1696484
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0032740
UMLS CUI [2,3]
C1260970
UMLS CUI [2,4]
C1696484
Does the participant have bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph?
Beschreibung

Pulmonary edema on X-ray

Datentyp

boolean

Alias
UMLS CUI [1]
C2073424
Does the participant have no clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates?
Beschreibung

No left atrial hypertension

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2748577
UMLS CUI [1,2]
C0225860
UMLS CUI [1,3]
C2939072
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Does the participant have an age less than 18 years?
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Does the participant have greater than 96 hours since first meeting ARDS criteria per the Berlin definition of ARDS?
Beschreibung

More than 96 hours since meeting Berlin criteria

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4699705
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C0243161
UMLS CUI [1,4]
C0035222
Is the participant pregnant or breast-feeding?
Beschreibung

Pregnant or breast-feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Is the participant a Prisoner?
Beschreibung

Prisoner

Datentyp

boolean

Alias
UMLS CUI [1]
C0033167
Does the participant have presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years?
Beschreibung

Active malignancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205177
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C0686904
UMLS CUI [1,4]
C0087111
UMLS CUI [1,5]
C0332185
Does the participant have any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%?
Beschreibung

Fatal condition

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1880198
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0038954
UMLS CUI [1,5]
C0205251
UMLS CUI [2,1]
C1880198
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0348080
UMLS CUI [2,4]
C0038954
UMLS CUI [2,5]
C0205251
Does the participant have moderate to severe liver failure (Childs-Pugh Score > 12)?
Beschreibung

Liver failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205081
UMLS CUI [1,2]
C0085605
UMLS CUI [2,1]
C0205082
UMLS CUI [2,2]
C0085605
Does the participant have severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen?
Beschreibung

Respiratory disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205082
UMLS CUI [1,2]
C0264220
UMLS CUI [1,3]
C0201931
UMLS CUI [1,4]
C0205250
UMLS CUI [2,1]
C0205082
UMLS CUI [2,2]
C0264220
UMLS CUI [2,3]
C0201931
UMLS CUI [2,4]
C1960973
Does the participant , surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)?
Beschreibung

Not commited to full support

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0443225
UMLS CUI [1,3]
C0496675
UMLS CUI [1,4]
C0870312
UMLS CUI [1,5]
C0332197
UMLS CUI [2,1]
C4053457
UMLS CUI [2,2]
C0443225
UMLS CUI [2,3]
C0496675
UMLS CUI [2,4]
C0870312
UMLS CUI [2,5]
C0332197
UMLS CUI [3,1]
C0031831
UMLS CUI [3,2]
C0443225
UMLS CUI [3,3]
C0496675
UMLS CUI [3,4]
C0870312
UMLS CUI [3,5]
C0332197
UMLS CUI [4,1]
C0332300
UMLS CUI [4,2]
C0443225
UMLS CUI [4,3]
C0344211
UMLS CUI [4,4]
C0582114
Does the participant have had major trauma in the prior 5 days?
Beschreibung

Recent major trauma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332677
UMLS CUI [1,2]
C0332185
Is the participant a Lung transplant patient?
Beschreibung

Lung transplant

Datentyp

boolean

Alias
UMLS CUI [1]
C0024128
Does the participant have No consent/inability to obtain consent?
Beschreibung

No consent/inability to obtain consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0021430
UMLS CUI [2,1]
C1299582
UMLS CUI [2,2]
C1301820
UMLS CUI [2,3]
C0021430
Is the participant a moribund patient not expected to survive 24 hours?
Beschreibung

Moribund

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0424547
UMLS CUI [1,2]
C0038952
UMLS CUI [1,3]
C0750558
Does the participant have WHO Class III or IV pulmonary hypertension?
Beschreibung

Pulmonary Hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C4087439
UMLS CUI [2]
C4087440
Does the participant have documented deep venous thrombosis or pulmonary embolism within past 3 months?
Beschreibung

Deep venous thrombosis or pulmonary embolism

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301725
UMLS CUI [1,2]
C0149871
UMLS CUI [1,3]
C0034065
UMLS CUI [1,4]
C0332185
UMLS CUI [1,5]
C0439231
Does the participant have no arterial line/no intent to place an arterial line?
Beschreibung

Arterial line

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003835
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1283828
UMLS CUI [2,2]
C0003835
UMLS CUI [2,3]
C0332197
Does the participant have no intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol?
Beschreibung

Lung protective ventilation and fluid management

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1283828
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C4281991
UMLS CUI [1,4]
C0679688
UMLS CUI [1,5]
C0035213
UMLS CUI [2,1]
C0600109
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C4281991
UMLS CUI [2,4]
C0553741
UMLS CUI [2,5]
C0442711
UMLS CUI [3,1]
C1283828
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C4281991
UMLS CUI [3,4]
C0553741
UMLS CUI [3,5]
C0442711
UMLS CUI [4,1]
C1283828
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0553741
UMLS CUI [4,4]
C0442711
Is the participant currently receiving extracorporeal life support (ECLS) or high-frequency oscillatory ventilation (HFOV)?
Beschreibung

ECLS or HFOV

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442087
UMLS CUI [1,2]
C0023678
UMLS CUI [2]
C0419017
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Ähnliche Modelle

Eligibility Criteria

1 Formulare
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Need for PEEP ventilation
Item
Does the participant have a need for positive pressure ventilation by an endotracheal or tracheal tube with a PaO2/FiO2 ratio < 200 with at least 8 cm H2O positive end-expiratory airway pressure (PEEP)?
boolean
C0686904 (UMLS CUI [1,1])
C0032740 (UMLS CUI [1,2])
C0336630 (UMLS CUI [1,3])
C1696484 (UMLS CUI [1,4])
C0686904 (UMLS CUI [2,1])
C0032740 (UMLS CUI [2,2])
C1260970 (UMLS CUI [2,3])
C1696484 (UMLS CUI [2,4])
Pulmonary edema on X-ray
Item
Does the participant have bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph?
boolean
C2073424 (UMLS CUI [1])
No left atrial hypertension
Item
Does the participant have no clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates?
boolean
C2748577 (UMLS CUI [1,1])
C0225860 (UMLS CUI [1,2])
C2939072 (UMLS CUI [1,3])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Age
Item
Does the participant have an age less than 18 years?
boolean
C0001779 (UMLS CUI [1])
More than 96 hours since meeting Berlin criteria
Item
Does the participant have greater than 96 hours since first meeting ARDS criteria per the Berlin definition of ARDS?
boolean
C4699705 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C0035222 (UMLS CUI [1,4])
Pregnant or breast-feeding
Item
Is the participant pregnant or breast-feeding?
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prisoner
Item
Is the participant a Prisoner?
boolean
C0033167 (UMLS CUI [1])
Active malignancy
Item
Does the participant have presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years?
boolean
C0205177 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0332185 (UMLS CUI [1,5])
Fatal condition
Item
Does the participant have any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%?
boolean
C1880198 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0038954 (UMLS CUI [1,4])
C0205251 (UMLS CUI [1,5])
C1880198 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0348080 (UMLS CUI [2,3])
C0038954 (UMLS CUI [2,4])
C0205251 (UMLS CUI [2,5])
Liver failure
Item
Does the participant have moderate to severe liver failure (Childs-Pugh Score > 12)?
boolean
C0205081 (UMLS CUI [1,1])
C0085605 (UMLS CUI [1,2])
C0205082 (UMLS CUI [2,1])
C0085605 (UMLS CUI [2,2])
Respiratory disease
Item
Does the participant have severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen?
boolean
C0205082 (UMLS CUI [1,1])
C0264220 (UMLS CUI [1,2])
C0201931 (UMLS CUI [1,3])
C0205250 (UMLS CUI [1,4])
C0205082 (UMLS CUI [2,1])
C0264220 (UMLS CUI [2,2])
C0201931 (UMLS CUI [2,3])
C1960973 (UMLS CUI [2,4])
Not commited to full support
Item
Does the participant , surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)?
boolean
C0030705 (UMLS CUI [1,1])
C0443225 (UMLS CUI [1,2])
C0496675 (UMLS CUI [1,3])
C0870312 (UMLS CUI [1,4])
C0332197 (UMLS CUI [1,5])
C4053457 (UMLS CUI [2,1])
C0443225 (UMLS CUI [2,2])
C0496675 (UMLS CUI [2,3])
C0870312 (UMLS CUI [2,4])
C0332197 (UMLS CUI [2,5])
C0031831 (UMLS CUI [3,1])
C0443225 (UMLS CUI [3,2])
C0496675 (UMLS CUI [3,3])
C0870312 (UMLS CUI [3,4])
C0332197 (UMLS CUI [3,5])
C0332300 (UMLS CUI [4,1])
C0443225 (UMLS CUI [4,2])
C0344211 (UMLS CUI [4,3])
C0582114 (UMLS CUI [4,4])
Recent major trauma
Item
Does the participant have had major trauma in the prior 5 days?
boolean
C0332677 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Lung transplant
Item
Is the participant a Lung transplant patient?
boolean
C0024128 (UMLS CUI [1])
No consent/inability to obtain consent
Item
Does the participant have No consent/inability to obtain consent?
boolean
C0332197 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1299582 (UMLS CUI [2,1])
C1301820 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
Moribund
Item
Is the participant a moribund patient not expected to survive 24 hours?
boolean
C0424547 (UMLS CUI [1,1])
C0038952 (UMLS CUI [1,2])
C0750558 (UMLS CUI [1,3])
Pulmonary Hypertension
Item
Does the participant have WHO Class III or IV pulmonary hypertension?
boolean
C4087439 (UMLS CUI [1])
C4087440 (UMLS CUI [2])
Deep venous thrombosis or pulmonary embolism
Item
Does the participant have documented deep venous thrombosis or pulmonary embolism within past 3 months?
boolean
C1301725 (UMLS CUI [1,1])
C0149871 (UMLS CUI [1,2])
C0034065 (UMLS CUI [1,3])
C0332185 (UMLS CUI [1,4])
C0439231 (UMLS CUI [1,5])
Arterial line
Item
Does the participant have no arterial line/no intent to place an arterial line?
boolean
C0003835 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1283828 (UMLS CUI [2,1])
C0003835 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Lung protective ventilation and fluid management
Item
Does the participant have no intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol?
boolean
C1283828 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C4281991 (UMLS CUI [1,3])
C0679688 (UMLS CUI [1,4])
C0035213 (UMLS CUI [1,5])
C0600109 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C4281991 (UMLS CUI [2,3])
C0553741 (UMLS CUI [2,4])
C0442711 (UMLS CUI [2,5])
C1283828 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C4281991 (UMLS CUI [3,3])
C0553741 (UMLS CUI [3,4])
C0442711 (UMLS CUI [3,5])
C1283828 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0553741 (UMLS CUI [4,3])
C0442711 (UMLS CUI [4,4])
ECLS or HFOV
Item
Is the participant currently receiving extracorporeal life support (ECLS) or high-frequency oscillatory ventilation (HFOV)?
boolean
C0442087 (UMLS CUI [1,1])
C0023678 (UMLS CUI [1,2])
C0419017 (UMLS CUI [2])
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