Mesenchymal Stem Cells for The Treatment of Chronic Obstructive Pulmonary Disease

NCT04206007 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: UMC119-06-COPD-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease Moderate

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• The incidence and frequency of adverse events related to administration of UMC119-06.

  * Incidence of Treatment-Emergent Adverse Events (TEAEs). * Incidence of withdrawals due to Adverse Events(AEs).

  3 months from the day of administration

Secondary Outcomes (6)

• Changes in Forced Vital Capacity (FVC).

  15 months from the day of administration.

• Changes in Forced Expiratory Volume in One Second (FEV1).

  15 months from the day of administration.

• Changes in the ratio of Forced Expiratory Volume in One Second to the Forced Vital Capacity (FEV1/FVC).

  15 months from the day of administration

• Changes in exercise performance using 6-min walk test (6MWT).

  15 months from the day of administration.

• Changes in Quality Of Life using St. George's Respiratory Questionnaire Safety (SGRQ).

  15 months from the day of administration.

Study Arms (1)

UMC119-06

EXPERIMENTAL

Human Umbilical Cord Derived-Mesenchymal Stem Cells, Single treatment by intravenous infusion.

Biological: UMC119-06

Interventions

UMC119-06 BIOLOGICAL

Cohort 1: Low does of UMC119-06 Cohort 2: Medium does of UMC119- 06 Cohort 3: High does of UMC119-06

UMC119-06

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Meridigen Biotech Co., Ltd.: lead

Study Sites (1)

Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare.

New Taipei City, 23561, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 20, 2019
• Study Start: June 11, 2020
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: December 4, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)