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A Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy on Idiopathic Pulmonary Fibrosis (IPF)

NCT06081621 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2026-03-18

No results posted yet for this study

Summary

Idiopathic pulmonary fibrosis (IPF) is a serious chronic (long term) disease with injury of lung tissues. REGEND001 is a cell therapy product, made from bronchial basal cells with ability to regenerate lung tissue, is promising to IPF treatment. This is a multi-center, randomized, double-blinded, parallel and placebo-controlled phase II clinical study to evaluate the efficacy and safety of REGEND001 in IPF patients.

Conditions

Interventions

BIOLOGICAL

REGEND001

REGEND001: 1-1.5×10\^6 bronchial basal cells/kg administrated by bronchoscopy.

BIOLOGICAL

Placebo

Placebo: Sodium chloride injection administrated by bronchoscopy.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • RenJi Hospital

    collaborator OTHER

  • Ruijin Hospital

    collaborator OTHER

  • The Second Affiliated Hospital of Xiamen Medical College

    collaborator UNKNOWN

  • Regend Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-11
Primary Completion
2025-03-14
Completion
2025-03-14

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06081621 on ClinicalTrials.gov