Efficacy of Infusions of MSC From Wharton Jelly in the SARS-Cov-2 (COVID-19) Related Acute Respiratory Distress Syndrome

NCT04625738 | Completed Phase 2 DMC

• 1 other identifier: 2020-002772-12
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Mesenchymal stem cells (MSCs) are of potential help in acute respiratory distress syndrome (ARDS), due to their anti-inflammatory properties. The investigators will analyze the effect of 3 iterative infusions of ex vivo expanded Wharton's Jelly MSCs (total dose 2.10\^6/kg) in patients with ARDS due to COVID19, who require mechanical ventilation.

Conditions

COVID19 ARDS

Keywords

COVID; ARDS; MSC; mesenchymal stem cells; Wharton's Jelly; inflammation

Outcome Measures

Primary Outcomes (1)

• PaO2 / FiO2 ratio

  The primary endpoint is the percentage of patients with a PaO2/FiO2 ratio \> 200 at D10 of treatment with MSC-GW or placebo.

  day 10

Secondary Outcomes (14)

• respiratory function evolution

  between Day 0 (or Day 1) and Day 14 of treatment

• respiratory assistance

  between day 0 (or 1) and day 28 (or last day of hospitalization if before day 28)

• organ failures 1

  Day 0 to day 14

• organ failures 2

  day 0 to day 28

• organ failures 3

  day 0 to day 28

Study Arms (2)

MSC Arm

EXPERIMENTAL

Ex vivo expanded Wharton's Jelly derived mesenchymal stem cells will be infused at day 0, day 3 and day 5 (+/- 1 day), in patients with moderate to severe ARDS with a mechanical ventilation. day 0: 1.10\^6 MSC/kg day 3: 0.5. 10\^6 MSC/kg day 5: 0.5 . 10\^6 MSC/kg

Biological: Ex vivo expanded Wharton's Jelly Mesenchymal Stem Cells

Placebo Arm

PLACEBO COMPARATOR

Only the vehicle solution, without MSCs, containing albumin 4% , NaCl 0,9% and ACD will be injected to patients at day 0, 3 and 5 (+/-1 day).

Biological: Placebo

Interventions

Ex vivo expanded Wharton's Jelly Mesenchymal Stem Cells BIOLOGICAL

Ex vivo expanded Wharton's Jelly derived mesenchymal stem cells will be infused at day 0, day 3 and day 5 (+/- 1 day), in patients with moderate to severe ARDS with a mechanical ventilation. day 0: 1.10\^6 MSC/kg day 3: 0.5. 10\^6 MSC/kg day 5: 0.5 . 10\^6 MSC/kg

MSC Arm

Placebo BIOLOGICAL

Only the vehicle solution, without MSCs, containing albumin 4% , NaCl 0,9% and ACD will be injected to patients at day 0, 3 and 5 (+/-1 day).

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or woman 18 years of age or older
• Patient with a biologically confirmed SARS-CoV-2 infection (by positive RT-PCR on a nasopharyngeal sample or any other sample)
• Patient with moderate to severe ARDS according to the BERLIN definition defined by a PaO2 / FiO2 ratio \<200 and with endotracheal intubation and under invasive mechanical ventilation
• Patient hospitalized in the intensive care unit
• Any woman of childbearing age with a negative Beta HCG test
• Social Security affiliation

You may not qualify if:

• Patient under invasive mechanical ventilation for more than 48 hours
• Patient with a chronic respiratory disease under oxygen therapy
• Patients with a history of Class III or IV pulmonary arterial hypertension (WHO classification)
• Patients under ECMO
• Immunosuppressive therapy (including corticosteroid therapy\> 20 mg prednisolone)
• Active solid tumor or in remission for less than 2 years, malignant hematological disease, asplenia
• Patient who has received a hematopoietic stem transplantation or an organ transplant
• Therapeutic limitations like progression to expected death within 24 hours (according to the opinion of the medical team)
• Hypersensitivity to albumin or to any of the excipients (caprylic acid or sodium caprylate)
• Patient included in another ongoing interventional therapeutic trial
• Pregnant woman, parturient, nursing mother
• Minor (not emancipated)
• Person without liberty by judiciary or administrative decision
• Person undergoing psychiatric care under Articles L. 3212-1 and L. 3213-1 which do not fall under the provisions of Article L. 1121-8 (hospitalization without consent).
• Adult over 18 who are under a legal protection measure

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Nancy University Hospital

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (1)

• Pochon C, Laroye C, Kimmoun A, Reppel L, Dhuyser A, Rousseau H, Gauthier M, Petitpain N, Chabot JF, Valentin S, de Carvalho Bittencourt M, Peres M, Aarnink A, Decot V, Bensoussan D, Gibot S. Efficacy of Wharton Jelly Mesenchymal Stromal Cells infusions in moderate to severe SARS-Cov-2 related acute respiratory distress syndrome: a phase 2a double-blind randomized controlled trial. Front Med (Lausanne). 2023 Aug 29;10:1224865. doi: 10.3389/fmed.2023.1224865. eCollection 2023.

  PMID: 37706025 DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoine KIMMOUN, MD, PhD

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

• Sébastien GIBOT, MD, PhD

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator

Model Details: Phase IIa double-blind randomized controlled trial

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 12, 2020
• Study Start: November 6, 2020
• Primary Completion: May 14, 2021
• Study Completion: September 1, 2021
• Last Updated: November 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)