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Acute Respiratory Distress Syndrome

Mesenchymal Stem Cells for The Treatment of Acute Respiratory Distress Syndrome (ARDS)

Sponsored by Meridigen Biotech Co., Ltd.

About this trial

Last updated 2 years ago

Study ID

UMC119-06-ARDS-01

Status

Not yet recruiting

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
20 to 85 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 2 years ago

What is this trial about?

The clinical study with UMC119-06 is designed to investigate the safety in patients with moderate acute respiratory distress syndrome ("ARDS"). This will be a dose escalation, open-label, single-center study in adult with ARDS. UMC119-06 is ex vivo cultured human umbilical cord derived mensenchymal stem cells (hUC-MSCs) product which is intended for treatment of ARDS.

What are the participation requirements?

Yes

Inclusion Criteria

- Subjects of age ≥ 20 years and ≤ 85 years.

- Subject has a diagnosis of moderate ARDS according to the Berlin definition of ARDS:

1. No clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates.
2. Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph.
3. Hypoxemia: PaO2/ FiO2 > 100 mmHg to ≤ 200 mmHg with PEEP ≥ 5 cm H2O.
4. The time of onset of ARDS is when all of the specified ARDS criteria (2a-c) are met.

- Patient is intubated and mechanically ventilated.

- Subjects who had an onset of ARDS within 72 to 120 hours before start of treatment.

- Subjects with body weight between 40 to 90 kg.

- No decompensated heart failure.

- 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 serum 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/ml, OR;
2. 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy.
No

Exclusion Criteria

- Greater than 72 hours since first meeting ARDS criteria per the Berlin definition.

- No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol.

- Expected life < 3 months from other cause than the respiratory failure.

- Subject is receiving extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support.

- Subjects with history of any type of malignancy.

- Major trauma in the prior 5 days.

- 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 14 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 who have significant abnormal laboratory tests at screening:

1. >5 × upper limit of normal for alanine aminotransferase (ALT) or aspartate aminotransferase (AST).
2. >3 × upper limit of normal for total bilirubin.
3. >2 × upper limit of normal for serum creatinine.

- Subjects with known human immunodeficiency virus infection or who are immune compromised.

- Subjects who are 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 (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.

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