CSM-GW for Septic shock (community-acquired)

Inclusion criteria

• {"criterion_text":"- 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).\n- 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)\n- 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).\n- 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\n- 5-Person affiliated to a Social Security scheme or beneficiary of such a scheme."}

Exclusion criteria

• {"criterion_text":"- Non-septic shock\n- 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\n- Nosocomial septic shock\n- 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.\n- Rapport PaO2/FiO2 < 100\n- Encephalic death\n- Moribund patient\n- Existence of immediate therapeutic limitations\n- Patient included in another interventional therapeutic trial in progress or less than 30 days old\n- Known hypersensitivity to albumin or to one of the excipients (caprylic acid or sodium caprylate)."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the SOFA score (clinico-biological severity score ranging from 0 to 24 points) at D7 (or the day of death or discharge from intensive care if before D7) compared with that observed in patients in the control group.","definition_or_measurement_approach":"SOFA (Sepsis Organ Failure Assessment) score, range 0–24, measured at Day 7 or on the day of death or discharge from intensive care if earlier, compared between MSC and control groups."}

Secondary endpoints

• {"endpoint_text":"- For objective 1: Time to SOFA < 3 (in days). Start date = date of arrival in the intensive care unit, end date = D7.","definition_or_measurement_approach":"Time (days) from ICU arrival to achieving SOFA < 3, censored at Day 7."}
• {"endpoint_text":"- For the 2nd objective: i) Number of days living without respiratory assistance at D28, ii) Number of days living without catecholamines at D28, iii) Number of days living without extra-renal purification at D28, iv) Length of stay in intensive care and in hospital,","definition_or_measurement_approach":"i–iii: count of days alive and free of specified organ supports by Day 28; iv: duration (days) of ICU and hospital stay."}
• {"endpoint_text":"- For the 3rd objective: i) mortality at D28, ii) mortality at D90","definition_or_measurement_approach":"All-cause mortality assessed at Day 28 and Day 90."}
• {"endpoint_text":"- For the 4th objective i) Transient fall in PaO2/FiO2 ratio (or arterial desaturation >5%) within 2 hours of MSC administration ii) Transient rise in mean pulmonary arterial pressure (>5 mHg) within 2 hours of MSC administration iii) Shivering, hyperthermia within 2 hours of MSC administration iv) occurrence of pulmonary embolism within 2 hours of MSC administration v) occurrence of adverse events up to 90 days after MSC injection.","definition_or_measurement_approach":"Safety endpoints monitoring within 2 hours post‑MSC administration for immediate respiratory/pulmonary/hemodynamic events and monitoring of adverse events up to 90 days post-injection."}

France

Earliest CTIS Part Ii Submission Date

02-12-2024

Latest Decision Or Authorization Date

23-06-2025

Processing Time Days

203

Number Of Sites

2

Number Of Participants

66

Primary sponsor

Full Name

CHRU De Nancy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France