Trial record 1 of 237 for:    "cyclic neutropenia" OR "Neutropenia"
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Russian Clinical Trial of Mesenchymal Cells in Patients With Septic Shock and Severe Neutropenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by National Research Center for Hematology, Russia
Sponsor:
Information provided by (Responsible Party):
Elena N.Parovichnikova, National Research Center for Hematology, Russia
ClinicalTrials.gov Identifier:
NCT01849237
First received: May 1, 2013
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

Septic shock remains a significant clinical problem associated with high rates of mortality among neutropenic patient despite antimicrobial therapy and supportive care. Recently, mesenchymal stromal cells (MSC) have demonstrated remarkable potential effect in sepsis. MSC treatment significantly reduced mortality in septic mice receiving appropriate antimicrobial therapy. MSCs reduced systemic inflammatory cytokine levels in mice, down-regulated of inflammation and inflammation-related genes (such as interleukin-10, interleukin-6). Bacterial clearance was greater in MSC-treated mice. Thus, MSCs have beneficial effects on experimental sepsis and suggest that MSСs-therapy may be an effective adjunctive treatment to reduce sepsis-related mortality.

The safety of MSCs is proved by Graft-versus-host disease treatment MSCs in patients after bone marrow transplantation.

This study hypothesis is that MSCs reduce organ dysfunction/injury, systemic inflammation and mortality in patients with septic shock and severe neutropenia.

The main goal of the study is to evaluate the impact of MSCs therapy on organ dysfunction/injury, systemic inflammation and 28-day mortality in patients with septic shock and severe neutropenia. All patients will be randomized in two groups: control group (standard treatment of septic shock) and MSCs-group (standard treatment of septic shock + MSCs infusion of 1-2 millions/kg/ day).


Condition Intervention Phase
Septic Shock
Nonchemotherapy Drug-induced Neutropenia
Neutropenia After Chemotherapy in Oncohematological Patients
Neutropenia in Patients With Aplastic Anemia
Genetic: Mesenchymal stromal cells
Drug: Standard therapy of septic shock
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by National Research Center for Hematology, Russia:

Primary Outcome Measures:
  • mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of MSC therapy effects on organ dysfunction [ Time Frame: At Baseline and at day 2,3,7,14,21,28 ] [ Designated as safety issue: Yes ]
    1. Liver: levels of serum total bilirubin, transaminases, lactate dehydrogenase, plasma protrombin level
    2. Pancreas: amylase level
    3. Renal: number of hemodialysis/ hemodiafiltration, blood urea and creatinine levels
    4. Pulmonary: requirement for mechanical ventilation or non-invasive mechanical ventilation, pulmonary function-coefficient, partial oxygen pressure arterial blood level
    5. Cardiac: requirement for vasopressors, main parameters obtained from Transpulmonary Thermodilution- Systemic Vascular Resistance Index ( SVRI ), Cardiac Output (CO)

  • Evaluation of MSC therapy effects on systemic inflammatory parameters [ Time Frame: At Baseline and at day 2,3,7,14,21,28 ] [ Designated as safety issue: Yes ]
    plasma concentration of proinflammatory cytokine IL-6 and the antiinflammatory cytokine IL-10, concentration of procalcitonin, C-reactive protein Fibrinogen level, lactate level , the factor XII-dependent fibrinolytic activity blood routine examination

  • Evaluation of MSC therapy effects on septic shock reversal [ Time Frame: At Baseline and at day 2,3,7,14,21,28 ] [ Designated as safety issue: Yes ]
    SOFA score


Estimated Enrollment: 30
Study Start Date: December 2012
Estimated Study Completion Date: May 2015
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard therapy of septic shock
according to Surviving Sepsis Campaign 2012 Antibiotic therapy Fluid therapy Vasopressors Inotropic therapy Steroids
Drug: Standard therapy of septic shock
Antibiotic therapy Fluid therapy Vasopressors Inotropic therapy Steroids
Experimental: Mesenchymal stromal cells+ standard therapy of septic shock

MSCs intravenous infusion of 1-2 millions/kg/day will be performed not more than 10 hs after onset of septic shock in patients with severe neutropenia(≤ 1x10^9/l).

according to Surviving Sepsis Campaign 2012: Antibiotic therapy Fluid therapy Vasopressors Inotropic therapy Steroids

Genetic: Mesenchymal stromal cells
MSCs intravenous infusion of 1-2 millions/kg/day will be performed not more than 10 hs after onset of septic shock in patients with severe neutropenia(≤ 1x10^9/l).
Drug: Standard therapy of septic shock
Antibiotic therapy Fluid therapy Vasopressors Inotropic therapy Steroids

Detailed Description:

All activities related to this human subjects research have been guided by ethical principles and have been reviewed and approved Federalwide Assurance National Ctr for Hematology, FWA00006482. The goal of the trial is to evaluate plasma concentration of proinflammatory cytokine interleukin-6 and the antiinflammatory cytokine interleukin-10, plasma levels of blood creatinine, bilirubin, procalcitonin, C-reactive protein. Then we will evaluate requirement for renal replacement therapy, requirement for mechanical ventilation or non-invasive mechanical ventilation, pulmonary function-coefficient, partial oxygen pressure arterial blood level, electrocardiograms, Kaplan - Meier curve,28-days mortality.

  Eligibility

Ages Eligible for Study:   17 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01849237

Contacts
Contact: Gennady Galstyan, MD PhD +7(495)6124859 gengalst@gmail.com

Locations
Russian Federation
National Research Center for Hematology Recruiting
Moscow, Russian Federation, 125167
Contact: Gennady M Galstyan, MD PhD    +7(495)6124859    gengalst@gmail.com   
Principal Investigator: : Gennady M. Galstyan, , MD PhD         
Principal Investigator: Elena N. Parovichnikova, MD,PhD         
Sub-Investigator: Polina M. Makarova, MD         
Sub-Investigator: Vyacheslav A. Novikov, MD         
Sub-Investigator: Irina V. Kolosova, MD         
Sub-Investigator: Stanislav A. Keselman, MD         
Sub-Investigator: Alexandr Y. Mashkov, MD         
Sub-Investigator: Anna V. Krechetova, MD, PhD         
Sub-Investigator: Dmitri Tihomirov, PhD         
Sub-Investigator: Tatiana A. Garanzha, PhD         
Sub-Investigator: Larisa A. Kuzmina, MD, PhD         
Sponsors and Collaborators
National Research Center for Hematology, Russia
Investigators
Principal Investigator: Gennady M. Galstyan, MD PhD National Research center of Hematology
  More Information

Publications:
Responsible Party: Elena N.Parovichnikova, MD PhD, National Research Center for Hematology, Russia
ClinicalTrials.gov Identifier: NCT01849237     History of Changes
Other Study ID Numbers: RuMCeSS
Study First Received: May 1, 2013
Last Updated: May 8, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by National Research Center for Hematology, Russia:
Mesenchymal Stromal Cells
Septic Shock
Neutropenia
Procalcitonin
Interleukin-6
Interleukin-10
C-reactive protein
Survival
Organ dysfunction

Additional relevant MeSH terms:
Neutropenia
Anemia
Anemia, Aplastic
Shock
Shock, Septic
Hematologic Diseases
Bone Marrow Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on July 31, 2014