Acute Respiratory Distress SyndromePhase 1NCT05886985
Safety, Tolerability, and Efficacy of MatriPlax in Subjects With Acute Respiratory Distress Syndrome
A Phase 1 study testing MatriPlax in people with Acute Respiratory Distress Syndrome, run by BioSpring Medical Co., Ltd at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- MatriPlax
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2023to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
- Pulse rate ≥ 60 beats per minute (bpm) and ≤ 100 bpm
- Body temperature ≥ 35.5°C and ≤ 37.7°C
Who cannot join
- 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
Show all 29Show fewer
- 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
- History of severe allergic or anaphylactic reactions
- Known or suspected hypersensitivity or previous adverse reaction to any ingredients of study product
- Participation in a clinical trial of an interventional medicinal product within 12 weeks prior to Screening visit
- With any other uncontrolled illness judged by the principal investigator that entering the trial may be detrimental to the subject
- 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)
- Female subject with childbearing potential who has positive serum or urine pregnancy test at Screening Visit
- Unable to return for follow-up visits for clinical evaluation or laboratory studies
- Inappropriate to participate in this clinical study because of psychiatric disorders or any condition as judged by the principal investigator
- Hypersensitive to penicillin, streptomycin and amphotericin B antibiotics
- 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
- Use of estrogens/oral contraceptives within 6 weeks prior to Screening visit
- Current smoker or has smoked within 3 months prior to Screening visit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Taipei Medical University Hospital
Taipei, 110301
Han-Pin Kuo, M.D., Ph.D., +886-2-27372181, q8828@tmu.edu.tw
About this study
Official title: A Phase I Open-Label, Dose-Escalation Study to Evaluate Safety, Tolerability, and Efficacy of Allogeneic Placenta-derived Human Mesenchymal Stem Cells for the Treatment of Acute Respiratory Distress Syndrome
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.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- MatriPlax
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MatriPlaxDrug
Also called Placenta choriodecidual membrane-derived mesenchymal stem cells
MatriPlax contains pcMSCs (placenta choriodecidual membrane-derived mesenchymal stem cells) and will be given intravenously on Day 1 and Day 4
| Study group | Role | What they receive |
|---|---|---|
| MatriPlax | Experimental | Each subject will receive 2x10^7, 4x10^7, or 8x10^7 pcMSCs per administration Receives: Drug: MatriPlax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Day 1 to Day 29
Secondary outcomes (24)
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.
Measured: Baseline, Day 4, 6, 8, 15, 29
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.
Measured: Baseline, Day 8, 29
Overall survival
Overall survival is defined as the time from treatment to death.
Measured: Baseline, Day 29, Month 3, 6, 9, 12
All-cause mortality rate
All-cause mortality rate is defined as the rate of deaths from any cause in all participants.
Measured: Baseline, Day 29, Month 3, 6, 9, 12
Cumulative ventilator-free hours (VFH)
Only subjects who wean from the ventilator and have at least 48 consecutive weaning hours
Measured: Day 1 to 29
Time to the first weaning from ventilator
Only subjects who wean from the ventilator and have at least 48 consecutive weaning hours
Measured: Up to 12 months
Number of subjects weaned from ventilator
Only subjects who wean from the ventilator and have at least 48 consecutive weaning hours
Measured: Day 29
Intensive Care Unit (ICU) free hours
Only subjects who are stable for discharge from ICU and have at least 48 consecutive hours of discharge
Measured: Day 1 to 29
Time to the first ICU discharge
Only subjects who are stable for discharge from ICU and have at least 48 consecutive hours of discharge
Measured: Up to 12 months
Number of subjects discharged from ICU
Only subjects who are stable for discharge from ICU and have at least 48 consecutive hours of discharge
Measured: Day 29
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
Measured: Day 1 to 29
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.
Measured: Baseline, Day 4, 6, 8, 15, 29
Cumulative vasopressor free days
The cumulative vasopressor free days are the sum of the days without taking vasopressor up to Day 29 or death.
Measured: Day 1 to 29
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
Measured: Day 1 to 29
The net change in c-reactive protein (CRP) from baseline
C-reactive protein is an inflammatory marker
Measured: Baseline, Day 4, 6, 8, 15, and 29
The net change in D-dimer from baseline
D-dimer is an inflammatory marker
Measured: Baseline, Day 4, 6, 8, 15, and 29
The net change in Lactate Dehydrogenase (LDH) from baseline
LDH is an inflammatory marker
Measured: Baseline, Day 4, 6, 8, 15, and 29
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.
Measured: Month 3, 6, 9, 12
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.
Measured: Day 1 to 29
Incidence of TEAEs (treatment-emergent AEs) and SAEs
The number of TEAEs (treatment-emergent AEs) and SAEs that occur in the study
Measured: 12 months
Number of participants with abnormalities in vital signs
The vital signs include blood pressure, respiratory rate, oxygen saturation, pulse rate, and body temperature
Measured: Baseline, Day 1, 4, 6, 8, 15, 29, Month 3, 6, 9, 12
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.
Measured: Baseline, Day 1, 4, 6, 8, 15, 29, Month 3, 6, 9, 12
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))
Measured: Baseline, Day 1, 4, 6, 8, 15, 29
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)".
Measured: Baseline, Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- MatriPlax
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioSpring Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886985
- Sponsor's protocol ID
- MP-01
- Status last verified
- Jul 2023
- First submitted
- 24 May 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-Label, Dose-Escalation Study to Evaluate Safety, Tolerability, and Efficacy of Allogeneic Placenta-derived Human Mesenchymal Stem Cells for the Treatment of Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT05886985
- Acronym / sponsor ID
- MP-01
- Conditions
- Acute Respiratory Distress Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- BioSpring Medical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- MatriPlax
| Arm | Type | Receives |
|---|---|---|
| MatriPlax | Experimental | Drug: MatriPlaxEach subject will receive 2x10^7, 4x10^7, or 8x10^7 pcMSCs per administration |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Clinical diagnosis of moderate or severe ARDS according to the Berlin definition
- 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
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MatriPlaxAlso: Placenta choriodecidual membrane-derived mesenchymal stem cellsMatriPlax contains pcMSCs (placenta choriodecidual membrane-derived mesenchymal stem cells) and will be given intravenously on Day 1 and Day 4 | Drug | MatriPlax |
Primary outcome
The incidence of treatment-emergent adverse events (TEAEs) up to 28 days after receiving MatriPlax
Time frame: Day 1 to Day 29
TEAEs are adverse events (AE) that occur after the study intervention administration
The incidence of serious adverse events (SAEs) up to 28 days after receiving MatriPlax
Time frame: Day 1 to Day 29
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
The incidence of suspected unexpected serious adverse reactions (SUSAR) up to 28 days after receiving MatriPlax
Time frame: Day 1 to Day 29
SUSAR is an SAE that is considered related to study intervention and unexpected judged by sponsor and investigator
24 secondary outcomes
Changes in PaO2/FiO2 ratio from baseline
Time frame: Baseline, Day 4, 6, 8, 15, 29
Changes in Lung injury score (LIS) from baseline
Time frame: Baseline, Day 8, 29
Overall survival
Time frame: Baseline, Day 29, Month 3, 6, 9, 12
All-cause mortality rate
Time frame: Baseline, Day 29, Month 3, 6, 9, 12
Cumulative ventilator-free hours (VFH)
Time frame: Day 1 to 29
Time to the first weaning from ventilator
Time frame: Up to 12 months
Number of subjects weaned from ventilator
Time frame: Day 29
Intensive Care Unit (ICU) free hours
Time frame: Day 1 to 29
Time to the first ICU discharge
Time frame: Up to 12 months
Number of subjects discharged from ICU
Time frame: Day 29
ICU/Respiratory Care Center (RCC) free hours
Time frame: Day 1 to 29
Changes in Sequential Organ Failure Assessment (SOFA) score from baseline
Time frame: Baseline, Day 4, 6, 8, 15, 29
Cumulative vasopressor free days
Time frame: Day 1 to 29
Cumulative oxygen support free hours
Time frame: Day 1 to 29
The net change in c-reactive protein (CRP) from baseline
Time frame: Baseline, Day 4, 6, 8, 15, and 29
The net change in D-dimer from baseline
Time frame: Baseline, Day 4, 6, 8, 15, and 29
The net change in Lactate Dehydrogenase (LDH) from baseline
Time frame: Baseline, Day 4, 6, 8, 15, and 29
The domain scores and total score of 12-item Short Form Survey (SF-12) Quality of Life (QoL) health survey questionnaire
Time frame: Month 3, 6, 9, 12
Number of subjects who experienced Dose Limiting Toxicity (DLT)
Time frame: Day 1 to 29
Incidence of TEAEs (treatment-emergent AEs) and SAEs
Time frame: 12 months
Number of participants with abnormalities in vital signs
Time frame: Baseline, Day 1, 4, 6, 8, 15, 29, Month 3, 6, 9, 12
Number of participants with abnormalities in physical examination
Time frame: Baseline, Day 1, 4, 6, 8, 15, 29, Month 3, 6, 9, 12
Number of participants with abnormalities in laboratory examination parameters
Time frame: Baseline, Day 1, 4, 6, 8, 15, 29
Number of participants with abnormalities in ECG parameters
Time frame: Baseline, Day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Background: PubMed 35585988Chen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MatriPlax in people with Acute Respiratory Distress Syndrome, run by BioSpring Medical 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 17 inclusion and 29 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: opening soon, as of the sponsor's last update on 27 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Han-Pin Kuo, M.D., Ph.D. (+886-2-27372181, q8828@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of treatment-emergent adverse events (TEAEs) up to 28 days after receiving MatriPlax (time frame: Day 1 to Day 29). The study lists 3 primary outcomes in all. 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 NCT05886985, which also lists 1 linked publication.
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 27 Jul 2023.