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Not yet recruitingNCT05886985Updated Jul 27, 2023

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

A Phase 1 interventional study of MatriPlax in Acute Respiratory Distress Syndrome, sponsored by BioSpring Medical Co., Ltd. Not yet recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by BioSpring Medical Co., Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

This open-label, dose-escalation Phase I study plans to evaluate the safety, tolerability, and efficacy of MatriPlax.

This is a conventional 3+3 dose-escalation study in which subjects with moderate or severe ARDS will receive intravenous MatriPlax infusion.

Participants will be assigned to one of three dose cohorts (low, middle and high doses of MatriPlax), depending on the time of their enrollment. Each participant will receive two doses of MatriPlax on Day 1 and Day 4. Each dose cohort will have three to six subjects enrolled sequentially with at least 1 week in between. All participants will be followed until 12 months after receiving MatriPlax or withdrawal from the study.

A Data Safety and Monitoring Board (DSMB) meeting will be held when all participants of each cohort complete their 28-day of treatment and evaluation period. The DSMB will determine if the study is safe to proceed to the next dose level or it requires to recruit more subjects to the concurrent dose level for safety evaluation.

02

Conditions studied

  • Acute Respiratory Distress Syndrome
03

In context

Respiratory Distress Syndrome

1,619 studies on the registry are indexed under Respiratory Distress Syndrome; 319 are open to participants now.

This study's planned enrollment of 24 is below the median of 60 across 973 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

This is the only study on the registry with BioSpring Medical Co., Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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
  2. Administration of study drug must be planned to take place within 72 hours since moderate or severe ARDS diagnosis
  3. Either gender, 20 \~ 80 years old (inclusive)
  4. Dated and signed informed consent
  5. A subject has been admitted to an ICU or RCC and is already on or candidates for mechanical ventilation
  6. A subject with the primary disease of ARDS caused by documented virus infection (including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2))

  7. With normal vital sign parameters:

    1. Systolic blood pressure ≥ 90 mmHg and ≤ 160 mmHg
    2. Diastolic blood pressure ≥ 50 mmHg and ≤ 95 mmHg
    3. Pulse rate ≥ 60 beats per minute (bpm) and ≤ 100 bpm
    4. Body temperature ≥ 35.5°C and ≤ 37.7°C

Exclusion criteria

Exclusion Criteria:

  1. No intent/unwillingness to follow lung-protective ventilation strategy or fluid management manual
  2. On extracorporeal membrane oxygenation (ECMO) support
  3. Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or with any oxygen support
  4. A subject who is extremely unlikely to survive more than 24 hours in the opinion of the investigator
  5. World Health Organization (WHO) Class III or IV pulmonary hypertension
  6. Clinical evidence of left ventricular failure
  7. 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
  8. Severe liver disease (Childs-Pugh Score > 10)

  9. 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)

  10. History of pulmonary embolism
  11. Previous solid organ transplant
  12. 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.
  13. Presence of any active malignancy within 2 years prior to Screening visit
  14. History of the human immunodeficiency virus (HIV) infection
  15. History of severe allergic or anaphylactic reactions
  16. Known or suspected hypersensitivity or previous adverse reaction to any ingredients of study product
  17. Participation in a clinical trial of an interventional medicinal product within 12 weeks prior to Screening visit
  18. With any other uncontrolled illness judged by the principal investigator that entering the trial may be detrimental to the subject

  19. Pregnant or lactating or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period. At least one form of birth control must be adopted. Acceptable forms include:

    • Placement of an intrauterine device (IUD) or intrauterine system (IUS).
    • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps)
  20. Female subject with childbearing potential who has positive serum or urine pregnancy test at Screening Visit
  21. Unable to return for follow-up visits for clinical evaluation or laboratory studies
  22. Inappropriate to participate in this clinical study because of psychiatric disorders or any condition as judged by the principal investigator
  23. Hypersensitive to penicillin, streptomycin and amphotericin B antibiotics
  24. With specific known risk factors for thrombotic events, including obesity (Body mass index (BMI) >35), diabetes mellitus Type I, history of deep vein thrombosis (DVT) or thrombotic episodes, acquired or inherited thrombophilic disorders, hypercoagulable conditions, and other cardiovascular risk factors judged by the investigator
  25. Use of estrogens/oral contraceptives within 6 weeks prior to Screening visit
  26. Current smoker or has smoked within 3 months prior to Screening visit.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    MatriPlax

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

    Drug: MatriPlax

Interventions

  • DrugMatriPlax

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 1 to Day 29

  2. 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

    Time frame: Day 1 to Day 29

  3. 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

    Time frame: Day 1 to Day 29

Secondary outcomes

  1. Changes in PaO2/FiO2 ratio from baseline

    The PaO2/FiO2 ratio is the ratio of arterial oxygen partial pressure (PaO2) to fractional inspired oxygen (FiO2), which is an indicator of the severity of ARDS.

    Time frame: Baseline, Day 4, 6, 8, 15, 29

  2. Changes in Lung injury score (LIS) from baseline

    The LIS is a standard measure of ARDS, which is composed of four components. Each component has 5 scores (0, 1, 2, 3 and 4-point) and the score of LIS is the average of the four components. A higher LIS indicates more severe lung injury.

    Time frame: Baseline, Day 8, 29

  3. Overall survival

    Overall survival is defined as the time from treatment to death.

    Time frame: Baseline, Day 29, Month 3, 6, 9, 12

  4. All-cause mortality rate

    All-cause mortality rate is defined as the rate of deaths from any cause in all participants.

    Time frame: Baseline, Day 29, Month 3, 6, 9, 12

  5. Cumulative ventilator-free hours (VFH)

    Only subjects who wean from the ventilator and have at least 48 consecutive weaning hours

    Time frame: Day 1 to 29

  6. Time to the first weaning from ventilator

    Only subjects who wean from the ventilator and have at least 48 consecutive weaning hours

    Time frame: Up to 12 months

  7. Number of subjects weaned from ventilator

    Only subjects who wean from the ventilator and have at least 48 consecutive weaning hours

    Time frame: Day 29

  8. Intensive Care Unit (ICU) free hours

    Only subjects who are stable for discharge from ICU and have at least 48 consecutive hours of discharge

    Time frame: Day 1 to 29

  9. Time to the first ICU discharge

    Only subjects who are stable for discharge from ICU and have at least 48 consecutive hours of discharge

    Time frame: Up to 12 months

  10. Number of subjects discharged from ICU

    Only subjects who are stable for discharge from ICU and have at least 48 consecutive hours of discharge

    Time frame: Day 29

  11. ICU/Respiratory Care Center (RCC) free hours

    Only subjects who are stable for discharge from ICU/RCC and have at least 48 consecutive hours of discharge

    Time frame: Day 1 to 29

  12. Changes in Sequential Organ Failure Assessment (SOFA) score from baseline

    The SOFA is a simple and objective score to evaluate the status of organ dysfunction of six organ systems (respiratory, coagulatory, liver, cardiovascular, renal, and neurologic). A subject is defined as free of organ failure when the SOFA score is zero. The total score of SOFA is 24.

    Time frame: Baseline, Day 4, 6, 8, 15, 29

  13. Cumulative vasopressor free days

    The cumulative vasopressor free days are the sum of the days without taking vasopressor up to Day 29 or death.

    Time frame: Day 1 to 29

  14. Cumulative oxygen support free hours

    The cumulative oxygen support free hours are the sum of hours without oxgen support up to Day 29 or death

    Time frame: Day 1 to 29

  15. The net change in c-reactive protein (CRP) from baseline

    C-reactive protein is an inflammatory marker

    Time frame: Baseline, Day 4, 6, 8, 15, and 29

  16. The net change in D-dimer from baseline

    D-dimer is an inflammatory marker

    Time frame: Baseline, Day 4, 6, 8, 15, and 29

  17. The net change in Lactate Dehydrogenase (LDH) from baseline

    LDH is an inflammatory marker

    Time frame: Baseline, Day 4, 6, 8, 15, and 29

  18. The domain scores and total score of 12-item Short Form Survey (SF-12) Quality of Life (QoL) health survey questionnaire

    The SF-12 QoL is a self-evaluated measurement of health status. It consists of eight domains and the score of each domain is transformed to a scale from 0 to 100. Zero indicates the worst health status, while 100 indicates the best health status.

    Time frame: Month 3, 6, 9, 12

  19. Number of subjects who experienced Dose Limiting Toxicity (DLT)

    A DLT is defined as any SAE OR any equal or greater than Grade 3 (CTCAE v5.0) AE judged as MatriPlax-related during Day 1 to 29. The CTCAE (Common Terminology Criteria for Adverse Events) is a classification system used to grade AE.

    Time frame: Day 1 to 29

  20. Incidence of TEAEs (treatment-emergent AEs) and SAEs

    The number of TEAEs (treatment-emergent AEs) and SAEs that occur in the study

    Time frame: 12 months

  21. Number of participants with abnormalities in vital signs

    The vital signs include blood pressure, respiratory rate, oxygen saturation, pulse rate, and body temperature

    Time frame: Baseline, Day 1, 4, 6, 8, 15, 29, Month 3, 6, 9, 12

  22. Number of participants with abnormalities in physical examination

    A physical examination includes general appearance, skin, eyes, ears, nose, throat, head and neck (including thyroid), heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal, neurological system, and other body systems if applicable.

    Time frame: Baseline, Day 1, 4, 6, 8, 15, 29, Month 3, 6, 9, 12

  23. Number of participants with abnormalities in laboratory examination parameters

    The laboratory examination parameters include hematology (hemoglobin, hematocrit, red blood cell (RBC), platelet, white blood cell (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils) and biochemistry (blood urea nitrogen (BUN), creatinine, albumin, total protein, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, C-reactive protein (CRP), prothrombin time (PT), D-dimer, Lactate Dehydrogenase (LDH))

    Time frame: Baseline, Day 1, 4, 6, 8, 15, 29

  24. Number of participants with abnormalities in ECG parameters

    The ECG parameters include ventricular rate, PR interval, QRS interval, and QT interval. Each parameters will be evaluated by the investigator as "Normal", "Abnormal, non-clinical significant (NCS)" or "Abnormal, clinical significant (CS)".

    Time frame: Baseline, Day 29

07

Study locations

1 site
  • Taipei Medical University Hospital
    Taipei, 110301, Taiwan
08

References and documents

Publications

  • 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. PubMed 35585988 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05886985
Lead sponsor
BioSpring Medical Co., Ltd
Responsible party
Sponsor
First posted
Jun 2, 2023
Start date
Dec 2023 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
May 2027 (estimated)
Last update
Jul 27, 2023

Study contacts

Han-Pin Kuo, M.D., Ph.D.
Contact
q8828@tmu.edu.tw
+886-2-27372181

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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