THERAPY DOSSIER · th-bcc544700718

Mesenchymal stromal cells, native or carrying the human IL-10 or hepatocyte growth factor gene, with prior delivery of the human glutathione peroxidase-1 gene to modify the lung microenvironment

Biologic · Cell therapy; no ChEMBL entity. No registered trial uses IL-10-, HGF- or GPx-1-gene-modified MSCs. Evidence recorded is cell-type-level: unmodified allogeneic MSC products in ARDS, the same indication as the source.

Non-drug Suggest a correction

Evidence & regulatory context

Mechanism: Cell therapy; no ChEMBL entity. No registered trial uses IL-10-, HGF- or GPx-1-gene-modified MSCs. Evidence recorded is cell-type-level: unmodified allogeneic MSC products in ARDS, the same indication as the source.
Target: Not recorded
Injury models: Chemical/toxin
Reported indication: Not recorded
First approval: Not recorded
Development stage: Not recorded
ChEMBL record: Not recorded
ChEMBL max phase: Not recorded
Synonyms: Not recorded
Note: Not recorded

Clinical trials 7

0 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT04371393 ↗PHASE3terminated

Remestemcel-L for moderate to severe COVID-19 acute respiratory distress syndrome

Acute Respiratory Distress Syndrome · COVID

Enrolment: 223 · Results not recorded

NCT03818854 ↗PHASE2completed

Phase 2b randomised double-blind placebo-controlled multicentre trial of allogeneic bone marrow-derived human MSCs for acute respiratory distress syndrome (START-2)

Respiratory Distress Syndrome, Adult

Enrolment: 120 · Results not recorded

NCT02097641 ↗PHASE2completed

Phase 2 randomised multicentre trial of allogeneic bone marrow-derived human MSCs for acute respiratory distress syndrome (START)

Respiratory Distress Syndrome, Adult

Enrolment: 60 · Results not recorded

NCT04390139 ↗PHASE1/PHASE2completed

Two doses of Wharton's jelly MSC (XCEL-UMC-BETA) in ARDS secondary to COVID-19: double-blind randomised placebo-controlled pilot

COVID-19 · Adult Respiratory Distress Syndrome

Enrolment: 26 · Results not recorded

NCT04355728 ↗PHASE1/PHASE2completed

Umbilical cord-derived MSCs for COVID-19 patients with acute respiratory distress syndrome

ARDS · COVID-19

Enrolment: 24 · Results not recorded

NCT07413978 ↗PHASE1/PHASE2recruiting

Phase I-II open-label dose-escalation of human umbilical cord MSC injection in moderate to severe acute respiratory distress syndrome

Acute Respiratory Distress Syndrome

Enrolment: 36 · Results not recorded

NCT03608592 ↗NAunknown

Human umbilical cord-derived mesenchymal stem cell therapy in acute respiratory distress syndrome

Acute Respiratory Distress Syndrome

Enrolment: 26 · Results not recorded

Preclinical evidence 1

1 studies reported at therapy level; 1 evidence entries itemised.

PMID 30521764 ↗2019Mixed findings

Identification and Modulation of Microenvironment Is Crucial for Effective Mesenchymal Stromal Cell Therapy in Acute Lung Injury.

MouseChemical/toxinGlutathione peroxidase-1 gene delivered before mesenchymal stromal cell adminis…

Model: Three models of acute lung injury induced by acid instillation, mechanical ventilation, or acid instillation followed by mechanical ventilation; parallel in vitro work with human small airway epithelial cells and human mesenchymal stromal cells exposed to plasma from patients with acute respiratory distress syndrome

The three injury models produced distinct lung proteomic profiles. Mesenchymal stromal cells protected against ventilator-induced lung injury but worsened acid-primed injury, with fibrotic development in a lung environment high in IL-6 and fibronectin and low in antioxidant capacity. Correcting the…

Extraction: extract · Supplied extraction confidence: 0.65. Machine-extracted fields require source verification.

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