Safety, Tolerability, and Efficacy of MatriPlax in Subjects With Acute Respiratory Distress Syndrome

NCT05886985 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: MP-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to explore the safety, tolerability, and efficacy in study intervention, MatriPlax, in subjects with Acute Respiratory Distress Syndrome (ARDS). MatriPlax contains placenta choriodecidual membrane-derived Mesenchymal Stem Cells (pcMSCs). Participants will receive two doses of MatriPlax on Day 1 and Day 4 and conduct efficacy and safety evaluations until 12 months after treatment or withdrawal from the study.

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (3)

• The incidence of treatment-emergent adverse events (TEAEs) up to 28 days after receiving MatriPlax

  TEAEs are adverse events (AE) that occur after the study intervention administration

  Day 1 to Day 29

• The incidence of serious adverse events (SAEs) up to 28 days after receiving MatriPlax

  SAE is an AE that results in any of the following outcomes: Death; Life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Congenital anomaly/birth defect; Based upon appropriate medical judgment, the event may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above

  Day 1 to Day 29

• The incidence of suspected unexpected serious adverse reactions (SUSAR) up to 28 days after receiving MatriPlax

  SUSAR is an SAE that is considered related to study intervention and unexpected judged by sponsor and investigator

  Day 1 to Day 29

Secondary Outcomes (24)

• Changes in PaO2/FiO2 ratio from baseline

  Baseline, Day 4, 6, 8, 15, 29

• Changes in Lung injury score (LIS) from baseline

  Baseline, Day 8, 29

• Overall survival

  Baseline, Day 29, Month 3, 6, 9, 12

• All-cause mortality rate

  Baseline, Day 29, Month 3, 6, 9, 12

• Cumulative ventilator-free hours (VFH)

  Day 1 to 29

Study Arms (1)

MatriPlax

EXPERIMENTAL

Each subject will receive 2x10\^7, 4x10\^7, or 8x10\^7 pcMSCs per administration

Drug: MatriPlax

Interventions

MatriPlax DRUG

MatriPlax contains pcMSCs (placenta choriodecidual membrane-derived mesenchymal stem cells) and will be given intravenously on Day 1 and Day 4

Also known as: Placenta choriodecidual membrane-derived mesenchymal stem cells

MatriPlax

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of moderate or severe ARDS according to the Berlin definition
• Acute onset of respiratory failure within 1 week of identified insult
• Respiratory failure associated with known ARDS risk factors and not fully explained by either cardiac failure or fluid overload
• Radiological abnormalities on chest X-ray or computerized tomography (CT) scan, i.e., bilateral infiltrates that are not fully explained by effusions, lobar/lung collapse, or nodules
• Hypoxic respiratory failure
• Moderate ARDS: PaO2/ FiO2 ratio \> 100 mmHg (13.3 kPa) to ≤ 200 mmHg (26.6 kPa) with positive end expiratory pressure (PEEP) ≥ 5 cmH2O
• Severe ARDS: PaO2/ FiO2 ratio ≤ 100 mmHg (13.3 kPa) with PEEP ≥ 5 cmH2O
• Administration of study drug must be planned to take place within 72 hours since moderate or severe ARDS diagnosis
• Either gender, 20 \~ 80 years old (inclusive)
• Dated and signed informed consent
• A subject has been admitted to an ICU or RCC and is already on or candidates for mechanical ventilation
• A subject with the primary disease of ARDS caused by documented virus infection (including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2))
• With normal vital sign parameters:
• Systolic blood pressure ≥ 90 mmHg and ≤ 160 mmHg
• Diastolic blood pressure ≥ 50 mmHg and ≤ 95 mmHg

You may not qualify if:

• No intent/unwillingness to follow lung-protective ventilation strategy or fluid management manual
• On extracorporeal membrane oxygenation (ECMO) support
• Severe chronic respiratory disease with a PaCO2 \> 50 mm Hg or with any oxygen support
• A subject who is extremely unlikely to survive more than 24 hours in the opinion of the investigator
• World Health Organization (WHO) Class III or IV pulmonary hypertension
• Clinical evidence of left ventricular failure
• With acute diseases or serious medical conditions include cardiovascular (such as cardiac arrhythmia, QT prolongation), pulmonary (except ARDS), hepatic, neurologic, metabolic, renal, psychiatric condition, autoimmune disease, medical history, physical findings, or laboratory abnormality that in the investigators' opinion are not in stable condition and participating in the study could adversely affect the safety of the subject
• Severe liver disease (Childs-Pugh Score \> 10)
• Acute or chronic kidney disease (Stage-3B, 4 or 5 renal impair; estimated glomerular filtration rate (eGFR) ˂ 60 mL/min/1.73 m\^2 or dialysis)
• Note: eGFR (mL/min/1.73 m\^2) = 186.3 × (serum creatinine in mg/dL)\^-1.154 × (age)\^-0.203× (0.742 if female) × (1.212 if African American/black)
• History of pulmonary embolism
• Previous solid organ transplant
• With major surgery within 14 days prior to Screening visit Note: Major surgery is defined as an invasive operative procedure where one or more of the following occurred: 1) A body cavity was entered; 2) A mesenchymal barrier was crossed; 3) A fascial plane was opened; 4) An organ was removed; 5) Normal anatomy was operatively altered. All other invasive operative procedures are minor surgeries.
• Presence of any active malignancy within 2 years prior to Screening visit
• History of the human immunodeficiency virus (HIV) infection

Sponsors & Collaborators

• BioSpring Medical Co., Ltd: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, 110301, Taiwan

Location

Related Publications (1)

• Chen MC, Lai KS, Chien KL, Teng ST, Lin YR, Chao W, Lee MJ, Wei PL, Huang YH, Kuo HP, Weng CM, Chou CL. pcMSC Modulates Immune Dysregulation in Patients With COVID-19-Induced Refractory Acute Lung Injury. Front Immunol. 2022 Apr 29;13:871828. doi: 10.3389/fimmu.2022.871828. eCollection 2022.

  PMID: 35585988 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Han-Pin Kuo, M.D., Ph.D.

CONTACT

+886-2-27372181; q8828@tmu.edu.tw

Study Design

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

Model Details: MatriPlax

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 2, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

TW (1)