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Chronic Obstructive Pulmonary Disease ModeratePhase 1NCT04206007

Mesenchymal Stem Cells for The Treatment of Chronic Obstructive Pulmonary Disease

A Phase 1 study testing UMC119-06 in people with Chronic Obstructive Pulmonary Disease Moderate, run by Meridigen Biotech Co., Ltd. at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years
What is being tested?
UMC119-06
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteTaiwan
Study dates
11 Jun 2020to 30 Jun 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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;
  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

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

    New Taipei City, 23561

Other trials in Taiwan

About this study

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

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.

Read the detailed description

Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of morbidity and mortality worldwide, predicted to be the third leading cause of death in adults by 2020. Patients with COPD are characterized with airflow limitation and chronic inflammation, which is caused by cigarette smoking, noxious particles or gases. These inhaled irritants will induce inflammation, emphysema and fibrosis though chronic exposure. The current pharmacological treatment of COPD is symptomatic and is mainly based on bronchodilators, such as selective β2-adrenergic agonists (short-and long-acting), anticholinergics, theophylline, or a combination of these drugs. In patients with continuing exacerbations, inhaled corticosteroids (ICSs) may be added in the form of a triple fixed dose combination inhaler that includes ICSs, long-acting β2-agonists (LABA) and inhaled long-acting muscarinic antagonists (LAMA). Although current clinical treatment strategies can improve and stabilize COPD states and quality of life, none of them are able to modify the progressive decline in lung function which is the hallmark of this disease. Therefore, development of new therapeutic modalities to improve the clinical outcomes and prognosis of COPD in adult patients is of urgent need. Among the more innovative, experimental therapies, mesenchymal stromal cells (MSCs) are proposed as a novel therapy with potential in treatment of COPD.

Being tested
UMC119-06
Keywords
COPD
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UMC119-06Biological

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

Study groups in NCT04206007
Study groupRoleWhat they receive
UMC119-06ExperimentalHuman Umbilical Cord Derived-Mesenchymal Stem Cells, Single treatment by intravenous infusion.
Receives: Biological: UMC119-06

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 3 months from the day of administration

Secondary outcomes (6)

  1. Changes in Forced Vital Capacity (FVC).

    Improvement in clinical function as assessed by mean change in Forced Vital Capacity (FVC).

    Measured: 15 months from the day of administration.

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

    Improvement in clinical function as assessed by mean change in Forced Expiratory Volume in One Second (FEV1).

    Measured: 15 months from the day of administration.

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

    Improvement in clinical function as assessed by mean change in the ratio of Forced Expiratory Volume in One Second to the Forced Vital Capacity (FEV1/FVC).

    Measured: 15 months from the day of administration

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

    Improvement in clinical function as assessed by mean change in exercise performance using 6-min walk test (6MWT).

    Measured: 15 months from the day of administration.

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

    Scores range from 0 (no impairment) to 100 (maximum impairment), with higher scores indicating more limitation. A decrease in score represents a decrease in disease related symptoms. Improvement in clinical function as assessed by mean change in Quality Of Life using St. George's Respiratory Questionnaire Safety (SGRQ).

    Measured: 15 months from the day of administration.

  6. Changes in modified medical research council (mMRC) -dyspnea scale.

    Scores range from 0 (no dyspnea) to 4 (severe dyspnea), with higher scores indicate worse COPD control. Improvement in clinical function as assessed by mean change in modified medical research council (mMRC) -dyspnea scale.

    Measured: 15 months from the day of administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2019
  2. Study start11 Jun 2020
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04206007
Sponsor's protocol ID
UMC119-06-COPD-01
Status last verified
Dec 2022
First submitted
18 Dec 2019
Last updated
4 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing UMC119-06 in people with Chronic Obstructive Pulmonary Disease Moderate, run by Meridigen Biotech Co., Ltd. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence and frequency of adverse events related to administration of UMC119-06. (time frame: 3 months from the day of administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04206007.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.

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