Effects of mesenchymal stem cells administration on organ failure during septic shock: Phase II randomized comprator-controlled study CHOC-MSC

Overview

Sponsor-declared trial summary

Key facts

Sponsor

CHRU De Nancy

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

19 Oct 2021 → ongoing

Decision date (initial)

2024-12-06

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-518019-20-00

EudraCT number

2017-004123-67

ClinicalTrials.gov

NCT02883803

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 4

1. 1- Determine the effect of MSCs administered in the early phase of septic shock on the time to SOFA < 3 within 7 days of arrival in the intensive care unit compared with that observed in patients in the control group.
2. 2- Assessing the role of MSCs in the occurrence and duration of individual organ failure
3. 3- Assess the role of MSCs on mortality at D28 and D90, and length of stay in intensive care,
4. 4- Study the immediate and 3-month tolerance profile of an injection of allogeneic Wharton's Jelly MSCs at a dose of 1.106/kg +/- 0.1 106/kg and a maximum of 80.106

Conditions and MedDRA coding

La population concernée est celle des patients hospitalisés en réanimation présentant un choc septique d’origine communautaire très sévère (≥ 2 défaillances d’organes autres qu’hémodynamiques) depuis moins de 12 heures.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 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. 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. 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. 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. 5-Person affiliated to a Social Security scheme or beneficiary of such a scheme.

Exclusion criteria 10

1. Non-septic shock
2. Nosocomial septic shock
3. 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.
4. Rapport PaO2/FiO2 < 100
5. Encephalic death
6. Moribund patient
7. Existence of immediate therapeutic limitations
8. Patient included in another interventional therapeutic trial in progress or less than 30 days old
9. Known hypersensitivity to albumin or to one of the excipients (caprylic acid or sodium caprylate).
10. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 4

1. For objective 1: Time to SOFA < 3 (in days). Start date = date of arrival in the intensive care unit, end date = D7.
2. 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,
3. For the 3rd objective: i) mortality at D28, ii) mortality at D90
4. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

CHRU De Nancy

Sponsor organisation

CHRU De Nancy

Address

Co N°34, 29 Avenue Du Mal De Lattre De Tassigny, Bp 60034 29 Avenue Du Mal De Lattre De Tassigny Bp 60034

City

Nancy Cedex

Postcode

54035

Country

France

Scientific contact point

Organisation

CHRU De Nancy

Contact name

Sébastien GIBOT

Public contact point

Organisation

CHRU De Nancy

Contact name

Sébastien GIBOT

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 26 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications