cfMSC Stem Cell Therapy Targeting COPD

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Biological: clonal fetal MSCs

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Lung-Ji Chang, Ph.D; Phone Number: +86 0755-86573763; Email: c@szgimi.org

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518000
      • Recruiting
      • Shenzhen Geno-immune Medical Institute
      • Contact: Lung-Ji Chang, Ph.D; Phone Number: +86 0755-86573763; Email: c@szgimi.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cfMSCs to treat Chronic Obstructive Pulmonary Disease	Biological: clonal fetal MSCs; cfMSCs to treat Chronic Obstructive Pulmonary Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with adverse events.	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.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung function index changes	Evaluate the changes of forced expiratory volume in one second (FEV1) to calculate the improvement rate of lung function compared with the baseline.	48 weeks
Lung function index changes	Evaluate the changes of carbon monoxide diffusion capacity (DLCO) to calculate the improvement rate of lung function compared with the baseline.	48 weeks
Inflammatory indicator changes	Determine blood inflammatory indicators including CRP, TNFa, IFNg, and IL-6 by molecular methods.	24 weeks
Inflammatory indicator changes	Analyze the blood cells related to inflammation index.	24 weeks
Exercise capacity and quality of life	Evaluate the exercise capacity of patients by 6-minute walking distance test.	48 weeks
Quality of life	Assess the quality of life of patients by St. George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT).	48 weeks
Acute exacerbation rate of COPD	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.	3 years
Survival status of patients	Evaluate the progression-free survival and overall survival of patients.	3 years
Survival status of patients	Analyze the correlation between cfMSC therapy and long-term survival of COPD patients.	3 years

Collaborators and Investigators

• Sponsor: Shenzhen Geno-Immune Medical Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease (COPD); Clonal fetal Mesenchymal Stem Cells (cfMSCs)
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: GIMI-IRB-26001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No