Actively Recruiting

Early Phase 1
Age: 40Years - 80Years
All Genders
NCT07355868

Treatment of Chronic Obstructive Pulmonary Disease (COPD) by REGEND007 Cell Therapy

Led by Regend Therapeutics · Updated on 2026-03-23

12

Participants Needed

1

Research Sites

38 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide with the characterization of obstructed airflow. In a large number of patients, diffusion function is impaired along with the progression of disease. REGEND007 cell therapy, comprised of airway basal cells with ability to regenerate lung tissue, is promising to COPD treatment. A prospective, single-arm, dose-escalation exploratory clinical study to evaluate the safety, tolerability and preliminary efficacy of different doses of REGEND007 cell therapy administered by intravenous infusion in the treatment of COPD, and to recommend appropriate treatment doses for subsequent clinical studies.

CONDITIONS

Official Title

Treatment of Chronic Obstructive Pulmonary Disease (COPD) by REGEND007 Cell Therapy

Who Can Participate

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Gender is not restricted; age between 40 and 80 years old (inclusive)
  • Diagnosed with COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) in 2025
  • Six-minute walk test distance between 150 meters and less than 600 meters during screening
  • Able to voluntarily sign informed consent and cooperate with study procedures and report condition changes
Not Eligible

You will not qualify if you...

  • Female subjects who are pregnant, breastfeeding, or planning pregnancy within one year; male subjects whose spouses plan pregnancy
  • Survival period estimated less than one year by investigator
  • Current or past malignant tumors except certain low-invasiveness cancers with over five years disease-free survival
  • Pneumonia within 4 weeks before screening
  • More than 4 moderate to severe acute COPD exacerbations requiring hospitalization within 1 year before screening
  • Recent or suspected novel coronavirus infection within 4 weeks before screening
  • History of invasive or non-invasive mechanical ventilation at screening
  • Active pulmonary tuberculosis, poorly controlled asthma, acute pulmonary embolism, or severe pulmonary hypertension
  • Severe non-pulmonary diseases in past 6 months judged unsuitable
  • Severe anemia or poorly controlled granulocytopenia or thrombocytopenia
  • History of suicidal risk, psychiatric disorders, or epilepsy
  • Severe malnutrition
  • Severe arrhythmias or significant heart conduction abnormalities
  • Participation in other trials with interventions or biological treatments within 4 weeks
  • Researchers or related personnel involved in this trial or their family members
  • Considered unsuitable by investigator for increased risk or interference with trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Fourth Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, China, 322000

Actively Recruiting

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Research Team

K

Kai Wang, Professor and Chief Physician

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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