RecruitingPhase 1Phase 2NCT07477600

cfMSC Stem Cell Therapy Targeting COPD

Clonal Fetal Mesenchymal Stem Cell Therapy for the Treatment of Chronic Obstructive Pulmonary Disease

Sponsor

Shenzhen Geno-Immune Medical Institute

Enrollment

30 participants

Start Date

Mar 10, 2026

Study Type

INTERVENTIONAL

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

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.

Eligibility

Min Age: 40 YearsMax Age: 80 Years

Inclusion Criteria7

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.

Exclusion Criteria10

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.