Treatment of Severe Infections With Mesenchymal Stem Cells (CHOCMSC)

Central Hospital, Nancy, France

Status: Unknown

Conditions: Septic Shock

Treatments: Biological: Injection of albumin alone; Biological: Injection of mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02883803

PHRCI 2012/CHOCMSC-GIBOT/SKJ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

66 participants in 2 patient groups

MSC

Experimental group

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.

Treatment:

Biological: Injection of mesenchymal stem cells

Placebo

Sham Comparator group

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 250 ml albumin 4%, infused for 30 minutes in central venous line.

Treatment:

Biological: Injection of albumin alone