Treatment of Chronic Obstructive Pulmonary Disease by Infusion of Allogenic Mesenchymal Stem Cells

Korábbi kezelés

• Has evidence of active malignancy or prior history of active malignancy that has not been in complete remission for at least 5 years prior to screening.
• Has initiated pulmonary rehabilitation (e.g., exercise training) within 3 months prior to screening which, in the opinion of the Principal Investigator (PI), may affect the study's results.
• Has had a moderate or severe exacerbation of COPD (defined by GOLD standard) or has required mechanical ventilation (not including continuous positive airway pressure [CPAP]) within 30 days prior to screening.
• Received systemic steroids or other immunosuppressants, immunomodulators, cytotoxic agents, chemotherapy, radiation therapy, or other cell therapies within 28 days or 5 half-lives, whichever is longer, prior to screening.
• Underwent major surgery (body organs that require anesthesia, such as tumor removal, open chest, heart surgery, abdominal surgery, intracranial surgery, or normal surgery for more than 3 hours, etc.) within 30 days prior to screening.
• With a known history of alcohol abuse or drug abuse within 5 years prior to screening.
• Participating in another clinical study of new investigational therapies or have received an investigational therapy within 3 months prior to screening.

Más betegség

• Diagnosed with asthma or other clinically relevant lung disease other than COPD (e.g., restrictive lung diseases, sarcoidosis, tuberculosis, idiopathic pulmonary fibrosis, bronchiectasis, or lung cancer).
• Has documented history of uncontrolled heart failure.
• Has pulmonary hypertension due to left heart condition.
• Has atrial fibrillation or significant congenital heart defect/disease.
• With current active infection including pulmonary infection, systemic infection, or severe local infections.
• With known stage ≥3 chronic kidney disease.
• With a known history of drug-related anaphylaxis or other severe allergic reactions to drug.
  • Note: "Severe" is defined as Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 3 or greater.
• With known human immunodeficiency virus infection or immunocompromised.

Laborértékek

• Have the following conditions in laboratory tests at screening:
  • >2 × upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST); or
  • Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2; or
  • White blood cells (WBC) <3.6 × 103/μL; or
  • Platelet counts <150 × 103/μL; or
  • Hemoglobin <10 g/dL; or
  • Spot urine albumin-creatinine ratio (UACR) ≥30 mg/g; or
  • Clinically significant hematuria or proteinuria deemed by the study investigator.
• With known allergy or hypersensitivity to any component of the investigational product (IP) formulation (normal saline and human serum albumin [HSA]).

Egyéb

• Is hospitalized at screening.
• With known alpha-1 antitrypsin deficiency.
• Pregnant (or plan to become pregnant within 3 months after study treatment) or lactating.
• Has a life expectancy of <6 months.

• Between ≥40 and ≤80 years of age, of either sex and of any race.
• With diagnosis of COPD based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) standard.
• Has a post-bronchodilator FEV1/FVC ratio <0.70.
• Has a post-bronchodilator FEV1 predicted value ≥30% and <80%.
• With a score ≥2 in the mMRC dyspnea scale.
• With a score ≥10 in the COPD Assessment Test (CAT).
• With a body weight ≥40 to ≤90 kg.
• The disease status of COPD has been stable as determined by the investigator, and the standard treatment for COPD was not adjusted within 3 months prior to screening.
• Is a current or ex-smoker, with a cigarette smoking history of ≥10 years or >10 pack-years.
• Women of child-bearing potential should have a negative urine pregnancy test at screening, UNLESS they meet the following criteria:
  • (1)Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with the serum follicle stimulating hormone (FSH) level >40 mIU/mL, OR; (2)6 weeks post-surgical bilateral oophorectomy with or without hysterectomy 11.Heterosexually active subjects must agree to use a double barrier method of birth control (or must have been surgically sterilized/post-menopausal) and not to donate sperms/eggs during the study.
  • 12.Willing to provide written informed consent to participate in the study.