drugset / Trial / NCT02796781

Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases

NCT02796781 ↗

Phase 1/2 Completed 15 enrolled Shanghai East Hospital Regend Therapeutics · collab
NaSingle-groupOpen-labelTreatment

Summary

Interstitial lung diseases (ILD) are a group of diseases affecting the lung interstitium. The lung scarring that occurs in ILD is often irreversible with only mitigating therapy available so far. This study intends to carry out an open, single-armed, phase I/II clinical trial to investigate whether lung stem cells can regenerate damaged lung tissue. During the treatment, lung stem cells will be isolated from patients' own bronchi and expanded in vitro. After careful characterization, cultured cells will be injected directly into the lesion by fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by measuring the key clinical indicators.

Timeline

Start
2016-10-12
Primary completion
2020-08-31
Completion
2020-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Lung stem cells Unknown 500000 cells/kg Other
Subject Lung stem cells Unknown 5e+06 cells/kg Other