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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01849237 |
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Date of registration:
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01/05/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Russian Clinical Trial of Mesenchymal Cells in Patients With Septic Shock and Severe Neutropenia
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Scientific title:
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Russian Single-center Open Randomized Clinical Trial of the Impact of Mesenchymal Stromal Cells Therapy on Organ Dysfunction and 28-day Mortality in Patients With Septic Shock and Severe Neutropenia. |
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Date of first enrolment:
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December 2012 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01849237 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Russian Federation
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Contacts
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Name:
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Gennady M. Galstyan, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Research center of Hematology |
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Name:
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Gennady M Galstyan, MD PhD |
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Address:
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Telephone:
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+7(495)6124859 |
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Email:
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gengalst@gmail.com |
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Affiliation:
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Name:
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Gennady Galstyan, MD PhD |
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Address:
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Telephone:
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+7(495)6124859 |
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Email:
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gengalst@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
septic shock
=10 hs after onset of septic shock severe neutropenia(= 1 10^9/l) Patients =17 years
Signed Informed Consent to treatment
Exclusion Criteria:
oncohematological patients with resistance to chemotherapy Unsigned Informed Consent to
treatment Age >75 years; Pregnancy
Age minimum:
17 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neutropenia in Patients With Aplastic Anemia
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Neutropenia After Chemotherapy in Oncohematological Patients
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Nonchemotherapy Drug-induced Neutropenia
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Septic Shock
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Intervention(s)
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Drug: Standard therapy of septic shock
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Genetic: Mesenchymal stromal cells
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Primary Outcome(s)
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mortality
[Time Frame: 28 days]
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Secondary Outcome(s)
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Evaluation of MSC therapy effects on organ dysfunction
[Time Frame: At Baseline and at day 2,3,7,14,21,28]
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Evaluation of MSC therapy effects on systemic inflammatory parameters
[Time Frame: At Baseline and at day 2,3,7,14,21,28]
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Evaluation of MSC therapy effects on septic shock reversal
[Time Frame: At Baseline and at day 2,3,7,14,21,28]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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