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Clinical study on the treatment of idiopathic pulmonary fibrosis by bronchoscopic infusion of self repairing airway epithelial cells

Clinical study on the treatment of idiopathic pulmonary fibrosis by bronchoscopic infusion of self repairing airway epithelial cells

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036648
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-10-01
Completion date
Unknown
Last updated
2022-01-18

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

Conditions

Idiopathic pulmonary fibrosis

Interventions

Experimental group:Bronchoscopic infusion of self repairing airway epithelial cells
Control group:Conventional therapy

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. According to the IPF diagnostic criteria issued by the American Thoracic Society and the European Respiratory Association in 2018, the clinical manifestations were progressive dyspnea, ventilation dysfunction with decreased diffusion function, hypoxemia and diffuse lung lesions on imaging. FVC > 50% predicted value, DLCO > 30% predicted value. Lung histology and high resolution CT (HRCT) showed common interstitial pneumonia (UIP); 2. 40-65 years old, both male and female; 3. Good compliance, mental health, can cooperate with clinical observation; 4. No complications (diabetes, acute infection, hyperthyroidism, heart failure, hepatitis, nephritis); 5. There are evaluable lesions that can be found by CT; 6. Fully informed of the purpose, method and possible discomfort of the clinical research, agreed to participate in the clinical study, and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who can't tolerate cell therapy; 2. Patients with obvious pulmonary infection requiring anti infection treatment (respiratory tract infection and systemic infection within 4 weeks before treatment); 3. Patients with malignant tumor; 4. Participants in other drug trials 3 months before enrollment; 5. Patients severe systemic diseases and other organ dysfunction; 6. Pregnant women, lactating women or those who have family planning recently and cannot take effective contraceptive measures; 7. Patients with obvious abnormal liver and kidney function (ALT > 1.5 times of upper limit of normal value; Cr > 1.5 times of upper limit of normal value); 8. People who are not suitable for the selection through The researchers assessment.

Design outcomes

Primary

MeasureTime frame
Pulmonary function;

Secondary

MeasureTime frame
High resolution computed tomography;Arterial partial pressure of oxygen;6-minute walk test;St George's score;Treatment endpoint events;Receptor for advanced glycation endproducts;Angiopoietin 2, ANGPT2;Biomarkers;

Countries

China

Contacts

Public ContactTao Ren

Shanghai Sixth People's Hospital

rentao305@163.com+86 18930177191

Outcome results

None listed

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