Mesenchymal Stem Cells for The Treatment of Chronic Obstructive Pulmonary Disease

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease Moderate focused on measuring COPD Read More

Inclusion Criteria:

• Subjects of age between ≥ 40 through ≤ 75 years.
• Subjects with diagnosis of COPD based on the Global Initiative for Chronic Obstructive Lung Diseases (GOLD) standard.
• Subjects with a post-bronchodilator FEV1/FVC ratio <0.7.
• Subjects with a post-bronchodilator FEV1 % predicted value ≥ 50% and < 80%.
• Subjects with score ≥ 2 in the modified Medical Research Council Dyspnea Scale (mMRC).
• Subjects with in COPD Assessment Test (CAT) score ≥ 10.
• Subjects with body weight between 40 to 90 kg.
• Subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided.

• Women of child-bearing potential should have a negative urine pregnancy test prior to administration of investigational product, UNLESS they meet the following criteria:

  1. Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40 mIU/m, OR;
  2. 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy
• If a male and heterosexually active with a female of childbearing potential, the subject must agree to use a double barrier method of birth control (or must have been surgically sterilized) and to not donate sperm during the study.

Exclusion Criteria:

• Subjects with history of any type of malignancy.
• Subjects with 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 previous 30 days.
• Subjects who are pregnant (or plan to become pregnant within 3 months of investigational product treatment) or lactating.
• Subjects who have a significant concomitant illness as judged by principal investigator (PI).
• Subjects with known human immunodeficiency virus infection or who are immune compromised.
• Subjects with a known history of alcohol abuse or drug abuse within the 5 years before study treatment administration.
• Subjects who are current smokers.
• Subjects unable to return for follow-up visits for clinical evaluation, laboratory studies, or imaging evaluation.
• Subjects with a history of severe allergic or anaphylactic reactions.
• Subjects with known allergy or hypersensitivity to any component of the formulation or hypersensitivity to any component of the formulation (normal saline and human serum albumin).
• Subjects who have participated in another clinical study of new investigational therapies or have received an investigational therapy within the 12 weeks before study drug administration.
• Subjects with known Alpha-1 antitrypsin deficiency.
• Subjects with current active infection including pulmonary infection, systemic infection or severe local infections.
• Subjects with exacerbation of COPD within the 12 weeks before study treatment administration.

• Subjects who have the following conditions in laboratory tests at screening;

  1. >2 × upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST); or
  2. >2 × ULN for serum creatinine.