REGEND001 Autologous Basal Layer Stem Cell Transplantation for Interstitial Lung Disease (ILD): A Translational Application Study

Phase 1RecruitingNCT06998706

Ruijin Hospital10 enrolled

Overview

This clinical trial evaluates the safety and efficacy of REGEND001, an autologous bronchial basal layer stem cell therapy, in patients with interstitial lung disease (ILD). The treatment involves harvesting the patient's own stem cells (expressing KRT5/P63 markers), expanding them ex vivo, and administering them via bronchoscopic infusion to regenerate damaged lung tissue.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interstitial Lung Disease (ILD)

Interventions

REGEND001 Autologous Basal Layer Stem Cell SuspensionBIOLOGICAL

REGEND001 Autologous Basal Layer Stem Cell Suspension is an innovative cell therapy product designed for chronic structural lung diseases, such as bronchiectasis. This treatment involves harvesting regenerative stem cells (expressing KRT5/P63 markers) from the patient's own bronchial basal layer via fiberoptic bronchoscopy. After isolation, purification, and ex vivo expansion, the cells are administered as a suspension through bronchoscopic infusion into damaged lung segments.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 40-75 years. 2. Confirmed diagnosis of ILD (e.g., IPF, connective tissue disease-associated ILD). 3. DLCO ≥30% and \<80% predicted. Exclusion Criteria: 1. Pregnancy, lactation, or plans for pregnancy within 1 year. 2. Active malignancy or history of malignancy. 3. Positive serology for HIV, HBV, HCV, or syphilis.

Locations (2)

Ruijin Hospital Hainan Branch, Shanghai Jiao Tong University School of Medicine

Qionghai, Hainan, China

RECRUITING

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Change in DLCO from baseline.

The diffusing capacity of the lungs for carbon monoxide (DLCO) is a measurement of the gas transfer capacity of lung.

Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment

Secondary Outcomes

Change in FVC from baseline

The forced vital capacity (FVC) is a measurement of the airflow capacity.

Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment

Incidence of adverse events and serious adverse events.

Time frame: Through study completion, an average of 6 months

High-resolution CT (HRCT) imaging scores

Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment

Quality of life (QoL) assessment via validated respiratory questionnaires

Score range: 0 to 100. Higher scores indicate a worse outcome

Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment

Data from ClinicalTrials.gov

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