cfMSC stem cell treatment for COPD

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

This research will test whether infusions of clonally derived fetal mesenchymal stem cells (cfMSCs) can safely improve symptoms and lung function in adults with moderate to severe COPD who have not responded to standard treatments.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Shenzhen Geno-Immune Medical Institute (other)
• Locations: 1 site (Shenzhen, Guangdong)
• Trial ID: NCT07477600 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 interventional trial gives intravenous infusions of fully characterized clonally derived fetal mesenchymal stem cells (cfMSCs) to adults with moderate to severe COPD whose prior treatments were ineffective. The main goals are to determine safety, tolerability, and preliminary signs of benefit while identifying an optimal cell dose. Investigators will monitor adverse events, lung function, symptom measures, and other clinical endpoints over follow-up visits after infusion. The rationale is that cfMSCs may reduce inflammation, secrete growth factors, and promote repair of alveolar and airway tissues to improve ventilation and gas exchange.

Who should consider this trial

Good fit: Adults aged 40–80 with GOLD II–IV (moderate to severe) COPD, clinically stable on conventional therapy for at least four weeks but not responding to treatment, with life expectancy over six months and at least six months of smoking cessation are the intended participants.

Not a fit: People with other serious lung diseases (for example active tuberculosis, bronchiectasis, interstitial lung disease, pulmonary hypertension), recent lung surgery, current invasive or noninvasive mechanical ventilation, ongoing smoking, or other exclusionary conditions are unlikely to benefit from or qualify for this intervention.

Why it matters

Potential benefit: If successful, cfMSC therapy could reduce COPD symptoms, improve lung function and gas exchange, and potentially support repair of damaged lung tissue.

How similar studies have performed: Prior clinical trials of adult-source MSCs for COPD have generally shown acceptable safety but mixed or limited efficacy, while clonally derived fetal MSCs represent a newer approach with limited clinical data so far.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Where this trial is running

Shenzhen, Guangdong

• Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Lung-Ji Chang, Ph.D

Conditions: Chronic Obstructive Pulmonary Disease, Clonal fetal Mesenchymal Stem Cells