cfMSC Stem Cell Therapy Targeting COPD
Recruiting · NCT07477600 · Interventional (participants receive a specific treatment) · Lead sponsor: Shenzhen Geno-Immune Medical Institute
View the official record on ClinicalTrials.gov →Interventions studied
clonal fetal MSCs
What this trial is about
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.
Who can take part
Age range
40 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Shenzhen Geno-immune Medical Institute - Shenzhen, Guangdong, China