Septic ShockCHOCMSCNCT02883803
Treatment of Severe Infections With Mesenchymal Stem Cells
A study testing Injection of mesenchymal stem cells and Injection of albumin alone in people with Septic Shock, run by Central Hospital, Nancy, France at 4 sites in France.
Trial summary
The main purpose at the early phase of septic shock on the evolution of organ failure judged by the SOFA (Sepsis Organ Failure Assessment score) score on Day 7 (or the day of death or the day of discharge from the intensive care unit if before Day 7) compared to SOFA score observed in patients in the control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Injection of mesenchymal stem cells and Injection of albumin alone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 4 sitesFrance
- Study dates
- Dec 2019to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Septic shock of community origin since less than 12 hours. The onset time of septic shock is the time of catecholamine introduction( adrenaline, noradrenaline, or dopamine > 8μg/kg/min)
- At least 2 organ failure other than hemodynamic
- Occurrence between Monday 8am and Friday 8am (for availability reasons of staff)
- Signature of informed consent (patient/close relative or reliable person)
- Affiliation to social security plan
Who cannot join
- Non-septic shock
- Nosocomial septic shock
- PaO2/FiO2 <100
- Pregnant or breast-feeding woman
- Brain death
- Dying person
- Therapeutic limitations
- Participation to another current interventional clinical trial or since less than 30 days
Trial locations and contacts
4 sites in 1 country.
France4 sites
Service de Réanimation Médicale, Hôpital Bocage
Dijon
Pierre-Emmanuel Charles
Service de Réanimation Médicale, Hôpital Central
Nancy
Sébastien GIBOT
Hôpital Hautepierre, Service de réanimation médicale
Strasbourg
UTCT, Hôpital Brabois
Vandœuvre-lès-Nancy
Danièle Bensoussan
Véronique Decot
About this study
Official title: Effects of Mesenchymal Stem Cells Administration on Organ Failure During Septic Shock: Phase II Randomized Comparator-controlled Study
The main purpose at the early phase of septic shock on the evolution of organ failure judged by the SOFA (Sepsis Organ Failure Assessment score) score on Day 7 (or the day of death or the day of discharge from the intensive care unit if before Day 7) compared to SOFA score observed in patients in the control group. The secondary purpose is to assess the role of heterologous mesenchymal stem cells on the occurrence and duration of failure of each organ and on the mortality at day 28 and day 90. The safety of administration will be also assessed.
Read the detailed description
Patients hospitalized in recovery unit and having a very severe septic shock with community origin (≥ 2 organ failures other than hemodynamic) since less than 12 hours, will receive 10^6/kg heterologous mesenchymal stem cells in 250 ml albumin 4%, infused for 30 minutes in central venous line or 250 ml albumin 4% alone.
- Conditions
- Septic Shock
- Being tested
- Injection of mesenchymal stem cells, Injection of albumin alone
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of mesenchymal stem cellsBiological
Injection of mesenchymal stem cells
Injection of albumin aloneBiological
Injection of albumin alone
| Study group | Role | What they receive |
|---|---|---|
| MSC | Experimental | Patients hospitalized in recovery unit and having a very severe septic shock with community origin (≥ 2 organ failures other than hemodynamic) since less than 12 hours, will receive 10^6/kg heterologous mesenchymal stem cells in 250 ml albumin 4%, infused for 30 minutes in central venous line. Receives: Biological: Injection of mesenchymal stem cells |
| Placebo | Sham comparator | Patients hospitalized in recovery unit and having a very severe septic shock with community origin (≥ 2 organ failures other than hemodynamic) since less than 12 hours, will receive 250 ml albumin 4%, infused for 30 minutes in central venous line. Receives: Biological: Injection of albumin alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOFA score
To assess the efficacy of a recovery treatment
Measured: Day 7 (or death day or day of recovery unit exit if before day 7)
Secondary outcomes (7)
Number of living days without catecholamines
Measured: Day 28
Number of living days without mechanical ventilation
Measured: Day 28
Number of living days without dialysis
Measured: Day 28
Duration of residence time in recovery unit
Measured: Day of exit from recovery unit, up to 90 days
Mortality, across all causes
Measured: Day 28
Mortality, across all causes
Measured: Day 90
Administration safety (i.e. side effects)
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startDec 2019 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien GIBOT, Principal investigator, Service de Réanimation Médicale, Hôpital Central, 54035, Nancy Cedex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883803
- Sponsor's protocol ID
- PHRCI 2012/CHOCMSC-GIBOT/SKJ
- Acronym
- CHOCMSC
- Status last verified
- Jul 2019
- First submitted
- 25 Aug 2016
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mesenchymal Stem Cells Administration on Organ Failure During Septic Shock: Phase II Randomized Comparator-controlled Study
- ClinicalTrials.gov ID
- NCT02883803
- Acronym / sponsor ID
- CHOCMSC / PHRCI 2012/CHOCMSC-GIBOT/SKJ
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose at the early phase of septic shock on the evolution of organ failure judged by the SOFA (Sepsis Organ Failure Assessment score) score on Day 7 (or the day of death or the day of discharge from the intensive care unit if before Day 7) compared to SOFA score observed in patients in the control group. The secondary purpose is to assess the role of heterologous mesenchymal stem cells on the occurrence and duration of failure of each organ and on the mortality at day 28 and day 90. The safety of administration will be also assessed.
Detailed description
Patients hospitalized in recovery unit and having a very severe septic shock with community origin (≥ 2 organ failures other than hemodynamic) since less than 12 hours, will receive 10^6/kg heterologous mesenchymal stem cells in 250 ml albumin 4%, infused for 30 minutes in central venous line or 250 ml albumin 4% alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSC | Experimental | Biological: Injection of mesenchymal stem cellsPatients hospitalized in recovery unit and having a very severe septic shock with community origin (≥ 2 organ failures other than hemodynamic) since less than 12 hours, will receive 10^6/kg heterologous mesenchymal stem cells in 250 ml albumin 4%, infused for 30 minutes in central venous line. |
| Placebo | Sham comparator | Biological: Injection of albumin alonePatients hospitalized in recovery unit and having a very severe septic shock with community origin (≥ 2 organ failures other than hemodynamic) since less than 12 hours, will receive 250 ml albumin 4%, infused for 30 minutes in central venous line. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Septic shock of community origin since less than 12 hours. The onset time of septic shock is the time of catecholamine introduction( adrenaline, noradrenaline, or dopamine > 8μg/kg/min)
- At least 2 organ failure other than hemodynamic
- Occurrence between Monday 8am and Friday 8am (for availability reasons of staff)
- Signature of informed consent (patient/close relative or reliable person)
- Affiliation to social security plan
Key exclusion criteria (8 listed)
- Non-septic shock
- Nosocomial septic shock
- PaO2/FiO2 <100
- Pregnant or breast-feeding woman
- Brain death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of mesenchymal stem cellsInjection of mesenchymal stem cells | Biological | MSC |
| Injection of albumin aloneInjection of albumin alone | Biological | Placebo |
Primary outcome
SOFA score
Time frame: Day 7 (or death day or day of recovery unit exit if before day 7)
To assess the efficacy of a recovery treatment
7 secondary outcomes
Number of living days without catecholamines
Time frame: Day 28
Number of living days without mechanical ventilation
Time frame: Day 28
Number of living days without dialysis
Time frame: Day 28
Duration of residence time in recovery unit
Time frame: Day of exit from recovery unit, up to 90 days
Mortality, across all causes
Time frame: Day 28
Mortality, across all causes
Time frame: Day 90
Administration safety (i.e. side effects)
Time frame: up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien GIBOT principal investigator
Service de Réanimation Médicale, Hôpital Central, 54035, Nancy Cedex
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of mesenchymal stem cells and Injection of albumin alone in people with Septic Shock, run by Central Hospital, Nancy, France at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sébastien GIBOT (+33383852970, s.gibot@chu-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SOFA score (time frame: Day 7 (or death day or day of recovery unit exit if before day 7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019.