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A randomized, double-blind, single-center, placebo-controlled, parallel-controlled clinical trial for umbilical cord mesenchymal stem cell injection for the treatment of inhaled lung injury

A randomized, double-blind, single-center, placebo-controlled, parallel-controlled clinical trial for umbilical cord mesenchymal stem cell injection for the treatment of inhaled lung injury

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020919
Enrollment
Unknown
Registered
2019-01-22
Start date
2020-01-01
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

Inhalation lung injury

Interventions

High dose group:2×10^8 cells/10mL
Medium dose group:1×10^8 cells/10mL
Low dose group:0.5×10^8 cells/10mL
Placebo group:0 cells/10mL

Sponsors

Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Comply with the diagnostic criteria for inhaled lung injury, the severity of the disease is moderate and above; (2) Aged between 18 and 60 years old male and female; (3) burn area (TBSA) = 30%, and the depth of burn is deep second degree burn and below; (4) Patients who voluntarily participate in this clinical study and can cooperate with doctors to carry out research and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) ALI/ARDS for non-inhalation lung injury; (2) Patients with physical and mental disabilities; (3) patients with malignant tumors; (4) Concomitant with other serious infectious diseases; (5) HBVHCV or HIV or tuberculosis test positive during patient screening; (6) Pregnant and lactating women; (7) Serious diseases of any major organ (such as heart failure due to lung injury, ventricular fibrillation, renal failure, pulmonary hypertension, cirrhosis); (8) The safety and efficacy evaluation that the investigator believes may affect the study; (9) suspected or confirmed to be allergic to any component of the stem cell preparation of the study; (10) Has participated in clinical research on stem cells.

Design outcomes

Primary

MeasureTime frame
Simple score of lung contusion;

Countries

China

Contacts

Public ContactFeng Zhu

Shanghai Changhai Hospital

759081781@qq.com+86 13186556989

Outcome results

None listed

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