The Safety and Feasibility of UMC119-06 Cell Therapy in Subjects With Chronic Obstructive Pulmonary Disease

UMC119-06-COPD-01

The clinical study with UMC119-06 is designed to investigate the safety in patients with Chronic Obstructive Pulmonary Disease. This will be a dose escalation, open label, single-center study in adult with chronic obstructive pulmonary disease. UMC119-06 is ex vivo cultured human umbilical cord tissue-derived mesenchymal stem cells product which is intended for treatment of chronic obstructive pulmonary disease.

2020-06-11

2023-12-31

2024-06-30

Active (not recruiting)

Early phase I

9

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.

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2023-12-04