Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
Chronic Obstructive Pulmonary Disease (COPD), Clonal fetal Mesenchymal Stem Cells (cfMSCs)
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.
Detailed description
Important Regulatory Notice: This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China. ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities. Chronic obstructive pulmonary disease (COPD) is a chronic airway inflammatory disease characterized by persistent airflow limitation, with high morbidity, disability and mortality worldwide. Traditional therapeutic methods such as bronchodilators and anti-inflammatory drugs can only relieve clinical symptoms, delay disease progression, but cannot repair the damaged alveolar and airway tissue structure, so the long-term prognosis is poor. Clonal fetal mesenchymal stem cells (cfMSCs) are isolated and clonally characterized fetal tissue-derived MSCs with demonstrated low allogeneity and multi-directional differentiation potential, which may modulate lung stromal cells, alveolar epithelial cells and airway epithelial cells to repair the damaged lung tissues and facilitate the regeneration of alveolar and airway structure, thus improving the lung ventilation as well as gas exchange function of the COPD patients. In addition, cfMSCs may secrete a variety of anti-inflammatory factors, growth factors and exosomes to inhibit the excessive inflammatory response in the lung tissue of COPD patients, improve the local microcirculation, and lay a foundation for the repair of damaged lung tissues. This study aims to evaluate the safety, tolerability and preliminary efficacy of fully characterized cfMSCs in patients with moderate to severe COPD whose prior treatment has been ineffective. The research will provide a new clinical strategy for treating COPD and determine the optimal cell dosage, administration route and long-term therapeutic effect of the stem cell therapy, and open up a new path for the regenerative repair of lung damage caused by chronic respiratory diseases.
Interventions
BIOLOGICALclonal fetal MSCs
cfMSCs to treat Chronic Obstructive Pulmonary Disease
Sponsors
Shenzhen Geno-Immune Medical Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events. | 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung function index changes | 48 weeks | Evaluate the changes of forced expiratory volume in one second (FEV1) to calculate the improvement rate of lung function compared with the baseline. |
| Inflammatory indicator changes | 24 weeks | Determine blood inflammatory indicators including CRP, TNFa, IFNg, and IL-6 by molecular methods. |
| Exercise capacity and quality of life | 48 weeks | Evaluate the exercise capacity of patients by 6-minute walking distance test. |
| Acute exacerbation rate of COPD | 3 years | Count the number of acute exacerbations of COPD in patients after treatment, and compare the difference of acute exacerbation rate between the stem cell therapy group and the conventional treatment group. |
| Survival status of patients | 3 years | Evaluate the progression-free survival and overall survival of patients. |
Countries
China
Contacts
CONTACTLung-Ji Chang, Ph.D
Outcome results
None listed