Chronic Obstructive Pulmonary Disease (COPD)Phase 1/2NCT07477600
cfMSC Stem Cell Therapy Targeting COPD
A Phase 1/2 study testing clonal fetal MSCs in people with Chronic Obstructive Pulmonary Disease (COPD), run by Shenzhen Geno-Immune Medical Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- clonal fetal MSCs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2027to 31 Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, 518000
Lung-Ji Chang, Ph.D, +86 0755-86573763, c@szgimi.org
About this study
Official title: 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.
Read the 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.
- Being tested
- clonal fetal MSCs
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), Clonal fetal Mesenchymal Stem Cells (cfMSCs)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clonal fetal MSCsBiological
cfMSCs to treat Chronic Obstructive Pulmonary Disease
| Study group | Role | What they receive |
|---|---|---|
| cfMSCs to treat Chronic Obstructive Pulmonary Disease | Experimental | Not described Receives: Biological: clonal fetal MSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 48 weeks
Inflammatory indicator changes
Determine blood inflammatory indicators including CRP, TNFa, IFNg, and IL-6 by molecular methods.
Measured: 24 weeks
Inflammatory indicator changes
Analyze the blood cells related to inflammation index.
Measured: 24 weeks
Exercise capacity and quality of life
Evaluate the exercise capacity of patients by 6-minute walking distance test.
Measured: 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.
Measured: 3 years
Survival status of patients
Evaluate the progression-free survival and overall survival of patients.
Measured: 3 years
Survival status of patients
Analyze the correlation between cfMSC therapy and long-term survival of COPD patients.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start30 Jun 2027 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Geno-Immune Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477600
- Sponsor's protocol ID
- GIMI-IRB-26001
- Status last verified
- Aug 2026
- First submitted
- 10 Mar 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clonal Fetal Mesenchymal Stem Cell Therapy for the Treatment of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07477600
- Acronym / sponsor ID
- GIMI-IRB-26001
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), Clonal fetal Mesenchymal Stem Cells (cfMSCs)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shenzhen Geno-Immune Medical InstituteUniversity, hospital or other
- Study start
- 30 Jun 2027 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cfMSCs to treat Chronic Obstructive Pulmonary Disease | Experimental | Biological: clonal fetal MSCs |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clonal fetal MSCscfMSCs to treat Chronic Obstructive Pulmonary Disease | Biological | cfMSCs to treat Chronic Obstructive Pulmonary Disease |
Primary outcome
Number of patients with adverse events.
Time frame: 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.
8 secondary outcomes
Lung function index changes
Time frame: 48 weeks
Lung function index changes
Time frame: 48 weeks
Inflammatory indicator changes
Time frame: 24 weeks
Inflammatory indicator changes
Time frame: 24 weeks
Exercise capacity and quality of life
Time frame: 48 weeks
Acute exacerbation rate of COPD
Time frame: 3 years
Survival status of patients
Time frame: 3 years
Survival status of patients
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing clonal fetal MSCs in people with Chronic Obstructive Pulmonary Disease (COPD), run by Shenzhen Geno-Immune Medical Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lung-Ji Chang, Ph.D (+86 0755-86573763, c@szgimi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.