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Effects of mesenchymal stem cells administration on organ failure during septic shock: Phase II randomized comprator-controlled study CHOC-MSC
EU CTIS ID: 2024-518019-20-00
What this study is testing
The main objective is to determine the effect of MSC administered in the early phase of septic shock on the evolution of organ failure as judged by the SOFA (Sepsis Organ Failure Assessment score) at D7 (or on the day of death or discharge from intensive care if before D7) compared with that observed in patients in the control group.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1-Patient aged 18 or over, For women under 60: Presence of a negative HCG test. CTFG recommendations (Recommendations related to contraception and pregnancy testing in clinical trials Version 1.1) must be followed. Effective methods of contraception must be used until the end of the clinical trial (J90).
- 2-Presence of community-acquired septic shock for less than 24 hours. The time of onset of septic shock is defined as the time of introduction of catecholamines With at least 2 organ failures other than hemodynamic (Respiratory: PaO2/FiO2 < 300 if mechanical ventilation or Respiratory rate > 24 if spontaneous ventilation; Neurological: Glasgow score < 13; Renal: oliguria < 0.5ml/kg/h for more than 4 hours or acute renal failure with creatininemia >20mg/L , Hematological: platelets < 100000/mm3 ; and/or Hepatic: bilirubinemia > 34 micromol/L)
- 3- Septic shock occurring between Sunday 5.00 pm and Friday 10.00 am (for reasons of availability of the CTU staff responsible for preparing the drug for the clinical trial).
- 4- Patient who has given consent or for whom consent has been obtained from a close relative/trusted person if applicable or inclusion in immediate life-threatening emergency situation if applicable
- 5-Person affiliated to a Social Security scheme or beneficiary of such a scheme.
You likely can't join if
- Non-septic shock
- Persons referred to in Articles 10, 31, 32, 33 and 34 of Regulation EU 536/2014. Pregnant woman, parturient or breastfeeding mother Minor person (not emancipated) Persons deprived of liberty (6) by a judicial decision or Major person subject to a legal protection measure (guardianship, curatorship, safeguard of justice) Major person unable to express consent
- Nosocomial septic shock
- Immunosuppression: current immunosuppressive therapy (including corticosteroid therapy > 20 mg prednisolone equivalent), solid tumor active or in remission for less than 5 years, hematological cancer, asplenia.
- Rapport PaO2/FiO2 < 100
- Encephalic death
See the full eligibility criteria
- 1-Patient aged 18 or over, For women under 60: Presence of a negative HCG test. CTFG recommendations (Recommendations related to contraception and pregnancy testing in clinical trials Version 1.1) must be followed. Effective methods of contraception must be used until the end of the clinical trial (J90).
- 2-Presence of community-acquired septic shock for less than 24 hours. The time of onset of septic shock is defined as the time of introduction of catecholamines With at least 2 organ failures other than hemodynamic (Respiratory: PaO2/FiO2 < 300 if mechanical ventilation or Respiratory rate > 24 if spontaneous ventilation; Neurological: Glasgow score < 13; Renal: oliguria < 0.5ml/kg/h for more than 4 hours or acute renal failure with creatininemia >20mg/L , Hematological: platelets < 100000/mm3 ; and/or Hepatic: bilirubinemia > 34 micromol/L)
- 3- Septic shock occurring between Sunday 5.00 pm and Friday 10.00 am (for reasons of availability of the CTU staff responsible for preparing the drug for the clinical trial).
- 4- Patient who has given consent or for whom consent has been obtained from a close relative/trusted person if applicable or inclusion in immediate life-threatening emergency situation if applicable
- 5-Person affiliated to a Social Security scheme or beneficiary of such a scheme.
- Non-septic shock
- Persons referred to in Articles 10, 31, 32, 33 and 34 of Regulation EU 536/2014. Pregnant woman, parturient or breastfeeding mother Minor person (not emancipated) Persons deprived of liberty (6) by a judicial decision or Major person subject to a legal protection measure (guardianship, curatorship, safeguard of justice) Major person unable to express consent
- Nosocomial septic shock
- Immunosuppression: current immunosuppressive therapy (including corticosteroid therapy > 20 mg prednisolone equivalent), solid tumor active or in remission for less than 5 years, hematological cancer, asplenia.
- Rapport PaO2/FiO2 < 100
- Encephalic death
- Moribund patient
- Existence of immediate therapeutic limitations
- Patient included in another interventional therapeutic trial in progress or less than 30 days old
- Known hypersensitivity to albumin or to one of the excipients (caprylic acid or sodium caprylate).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.