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Exploratory Study on the Treatment of Moderate to Severe Acute Respiratory Distress Syndrome in Children with Exosomes Derived from Induced Pluripotent Stem Cells (iPSC-Exo)

Exploratory Study on the Treatment of Moderate to Severe Acute Respiratory Distress Syndrome in Children with Exosomes Derived from Induced Pluripotent Stem Cells (iPSC-Exo)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097485
Enrollment
Unknown
Registered
2025-02-19
Start date
2025-02-20
Completion date
Unknown
Last updated
2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS

Interventions

Control group:No
iPSC-Exo group:iPSC-Exo atomization therapy

Sponsors

children’hospital capital institute of pediatric
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Age 1 to 12 years old; No gender limitation. 2. Children diagnosed with moderate to severe ARDS and expected to undergo mechanical ventilation for >24 hours. 3. The course of the disease was within 96 hours after the diagnosis of ARDS. 4. Obtain the informed consent of the guardian.

Exclusion criteria

Exclusion criteria: 1. Patients with severe allergies; Allergic to cell products; 2. Children with severe chronic respiratory diseases, PaCO2 > 50mmHg, requiring home oxygen therapy; 3. Moderate to severe liver failure; 4. Undergoing hemodialysis or peritoneal dialysis treatment; 5. Active malignant tumor; 6. Neuromuscular diseases; 7. Bone marrow transplant; 8. Congenital immunodeficiency, or secondary immunodeficiency; 9. Patients receiving extracorporeal circulation support (ECMO); 10. Severe congenital malformation, chromosome disease; 11. Terminal illness.

Design outcomes

Primary

MeasureTime frame
Changes in oxygenation index from baseline to day 7;

Secondary

MeasureTime frame
Incidence of serious adverse events;Murray lung injury Score;Mechanical ventilation time;ICU stay;28-days survival rate;Inflammatory index change;

Countries

China

Contacts

Public ContactLiu Shuang

children’hospital capital institute of pediatric

shuangliu1105@163.com+86 10 85695616

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026