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New treatment option for Chronic Obstructive Pulmonary Disease (COPD)
Official title cfMSC Stem Cell Therapy Targeting COPD
ClinicalTrials.gov ID: NCT07477600
What this study is testing
What is clonal fetal MSCs?
clonal fetal MSCs is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic obstructive pulmonary disease (copd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join 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;
You likely can't join if
- Combined with other serious lung diseases: asthma, active pulmonary tuberculosis, bronchiectasis, pulmonary embolism, interstitial lung disease...
- 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.