NCT07477600

Brief Summary

The primary objectives are to evaluate the safety and efficacy of infusion of fully characterized clonally derived fetal mesenchymal stem cells (cfMSCs) for the control of severe symptoms associated with moderate to severe chronic obstructive pulmonary disease.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
48mo left

Started Mar 2026

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Mar 2026Apr 2030

First Submitted

Initial submission to the registry

March 10, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 10, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2029

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2030

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

3.1 years

First QC Date

March 10, 2026

Last Update Submit

March 22, 2026

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease (COPD)Clonal fetal Mesenchymal Stem Cells (cfMSCs)

Outcome Measures

Primary Outcomes (1)

  • Number of patients with adverse events.

    Determine the safety and tolerability of clonal fetal Mesenchymal Stem Cell (cfMSC) therapy with Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, including acute reactions, fever and other adverse events.

    24 weeks

Secondary Outcomes (9)

  • Lung function index changes

    48 weeks

  • Lung function index changes

    48 weeks

  • Inflammatory indicator changes

    24 weeks

  • Inflammatory indicator changes

    24 weeks

  • Exercise capacity and quality of life

    48 weeks

  • +4 more secondary outcomes

Study Arms (1)

cfMSCs to treat Chronic Obstructive Pulmonary Disease

EXPERIMENTAL
Biological: clonal fetal MSCs

Interventions

clonal fetal MSCsBIOLOGICAL

cfMSCs to treat Chronic Obstructive Pulmonary Disease

cfMSCs to treat Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to understand the study protocol and the willingness to provide written informed consent;
  • Age 40-80 years old, male or female;
  • Diagnosed with moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (GOLD Ⅱ-Ⅳ).
  • Regular use of COPD conventional drugs for more than 3 months, and the condition is stable for more than 4 weeks;
  • ineffective clinical treatment;
  • Life expectancy \> 6 months;
  • At least six months smoking cessation, including non-smoking during the treatment and follow-up periods of the study.

You may not qualify if:

  • Combined with other serious lung diseases: asthma, active pulmonary tuberculosis, bronchiectasis, pulmonary embolism, interstitial lung disease, pulmonary hypertension, etc.;
  • A history of lung surgery (pneumonectomy, lung volume reduction surgery, etc.) or bronchial intervention surgery within 12 months;
  • Invasive or non-invasive mechanical ventilation history within 4 weeks, or moderate to severe acute exacerbation of COPD within 4 weeks;
  • Negative for HIV, HCV or syphilis serology;
  • A history of malignant tumors or malignant tumors under treatment;
  • Autoimmune diseases requiring long-term use of glucocorticoids or immunosuppressants;
  • Poorly controlled diabetes (fasting blood glucose \> 10.0 mmol/L) or severe metabolic diseases;
  • A history of alcohol or drug abuse, or mental diseases that cannot cooperate with the study;
  • Pregnancy or breastfeeding.
  • Unable or unwilling to comply with study specific schedules or procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Lung-Ji Chang, Ph.D

CONTACT

+86 0755-86573763c@szgimi.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 17, 2026

Study Start

March 10, 2026

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

April 30, 2030

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)