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cfMSC Stem Cell Therapy Targeting COPD

ConditionChronic Obstructive Pulmonary Disease (COPD)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorShenzhen Geno-Immune Medical Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • clonal fetal MSCs

    Biological/Vaccine

    cfMSCs to treat Chronic Obstructive Pulmonary Disease

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: cfMSCs to treat Chronic Obstructive Pulmonary DiseaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
24 weeks

Secondary outcomes

1

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.

Time frame
48 weeks
2

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.

Time frame
48 weeks
3

Inflammatory indicator changes

Determine blood inflammatory indicators including CRP, TNFa, IFNg, and IL-6 by molecular methods.

Time frame
24 weeks
4

Inflammatory indicator changes

Analyze the blood cells related to inflammation index.

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenzhen Geno-Immune Medical Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: