Acute Respiratory Distress SyndromePhase 2SUMMITNCT06308926
MRG-001 as an Immunoregulatory and Regenerative Therapy for ARDS Patients
A Phase 2 study testing MRG-001 (Low-dose) and MRG-001 (High-dose) in people with Acute Respiratory Distress Syndrome and Respiratory Failure, run by MedRegen LLC.
Trial summary
This is a phase IIa, dose-ranging, proof-of-concept study of MRG-001 in patients with ARDS. The aim is to determine the safety and preliminary efficacy of MRG-001 across two dose ranges. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Respiratory Failure, Respiratory Distress Syndrome
- What is being tested?
- MRG-001 (Low-dose) and MRG-001 (High-dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Jul 2026
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute Respiratory Distress Syndrome, manifested by the following and not explained by alternative diagnoses, for example but not limited to: Pulmonary Edema due to Congestive Heart Failure (CHF).
- Chest x-ray (CXR)* revealing bilateral infiltrates involving a minimum of three quadrants on frontal chest radiograph, consistent with pulmonary edema or bilateral ground glass opacities not fully explained by effusions, lobar or lung collapse, nodules, atelectasis or other etiology of infiltrates not due to ARDS.
- PaO2/FiO2 < 300.
- Requiring respiratory support [defined as mechanical ventilation, non-invasive ventilation (NIV) or high flow nasal canula (HFNC)] If on ventilator, settings must include positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) ≥5 cm H2O.
Who cannot join
- Age less than 18 years.
- Infiltrates with etiology suspected of mimicking ARDS, ie; Pulmonary Edema due to Congestive Heart Failure (CHF). (A Pulmonary Arterial Wedge Pressure (PAWP) of < 18 for >12 hours would rule out suspected CHF).
- Pregnancy documented or suspected in women of child bearing potential, unless ruled out by a negative pregnancy test during screening or breast feeding.
- Immunocompromised patients:
- 4.1. Organ or bone marrow transplant recipients and/or recent (within 2 months) chronic use of immunosuppressive drugs (tacrolimus, mycofenolate mofetil, cyclosporine, rapamycine, hydrochloroquine, azathiopurine, methotrexate), e.g., biologicals, JAK1/2 inhibitors, interferons, interleukins, (prednisone or related corticosteroids are allowed).
- 4.2. Patients with documented or suspected HIV/AIDS, hepatitis B/C or active lung disease with tuberculosis. 4.3. Patients with active cancer diagnosis or use of chemotherapy in the past 3 months.
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- Hypersensitivity to either of the components of MRG-001.
- The patient is known or suspected to be brain dead or is moribund (not expected to live >48 hours) or is unlikely to survive long enough to receive 3 injections (4 days) in the opinion of the investigator.
- The primary care physician is not committed to full support of the patient. (A DNR representing "no chest compression" only, would not necessarily be an exclusion. A DNR in which life support is withheld/withdrawn or is otherwise limited, would be an exclusion).
- Participation in another investigational protocol or use of another investigational drug within 30 days of enrollment.
- Enrollment time window has been exceeded (must be enrolled within 7 days of hospital admission and within 48 hours of development of ARDS).
- Significant pre-existing organ dysfunction prior to randomization:
- 10.1. Lung: Receiving supplemental home oxygen therapy at baseline for pre-existing medical condition (other than COVID-19), as documented in medical record. 10.2. Heart: Pre-existing congestive heart failure defined as an ejection fraction <20% as documented in the medical record. Clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction (past 3 months), heart and coronary vessel surgery (past 3 months), significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure >180 mm Hg and diastolic blood pressure >110 mm Hg. WHO Class III or IV pulmonary hypertension. 10.3. Renal: End-stage renal disease requiring renal replacement therapy or eGFR <30 mL/min. 10.4. Liver: Severe chronic liver disease defined as Child-Pugh Class C or pre-existing severe hepatic dysfunction (i.e.; portal hypertension, cirrhosis, ascites, esophageal variceal bleeding, acute hepatic necrosis). 10.5. Hematologic: Baseline platelet count <30,000/mm3 or hemoglobin levels <6.0 g/dL. 10.6. Neurological: Severe traumatic brain injury, with intracranial injury demonstrated by head CT 10.7. History of splenectomy or splenomegaly (spleen weighing > 750 g).
- Currently receiving extracorporeal life support (ECLS/ECMO) or high-frequency oscillatory ventilation (HFOV).
- Anticipated extubation within 24 hours of enrollment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase IIa, Double-Blind, Randomized, Multi-Center Study Comparing MRG-001 to Placebo in Patients With Acute Respiratory Distress Syndrome
This is a phase IIa, dose-ranging, proof-of-concept study of MRG-001 in patients with ARDS.
The aim is to determine the safety and preliminary efficacy of MRG-001 across two dose ranges.
- Conditions
- Acute Respiratory Distress Syndrome, Respiratory Failure, Respiratory Distress Syndrome, Respiratory Tract Diseases, Cytokine Storm
- Being tested
- MRG-001 (Low-dose), MRG-001 (High-dose), Placebo
- Keywords
- Acute Respiratory Distress Syndrome, MRG-001, Stem Cells, Immunomodulation
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Insufficiency, Respiratory Tract Diseases, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRG-001 (Low-dose)Drug
MRG-001 is subcutaneously administered.
MRG-001 (High-dose)Drug
MRG-001 is subcutaneously administered.
PlaceboOther
Saline placebo will be administered subcutaneously based on bodyweight and similar dose as the treatment group.
| Study group | Role | What they receive |
|---|---|---|
| MRG-001 (Low-dose) | Experimental | MRG-001 will be administered subcutaneously at 0.007 mL/kg. Patients will receive 3 injections per week every other day for a total of 2 weeks or until discharge from the ICU. Receives: Drug: MRG-001 (Low-dose) |
| MRG-001 (High-dose) | Experimental | MRG-001 will be administered subcutaneously at 0.01 mL/kg. Patients will receive 3 injections per week every other day for a total of 2 weeks or until discharge from the ICU. Receives: Drug: MRG-001 (High-dose) |
| Placebo | Placebo comparator | Sterile injectable saline will be administered subcutaneously at 0.01 mL/kg. Patients will receive 3 injections per week every other day for a total of 2 weeks or until discharge from the ICU. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemopoietic stem cell mobilization
The primary efficacy endpoint is the absolute change of hematopoietic stem cell mobilization (CD34+ cells) calculated as cells/μl at the peak of mobilization at 12 hours compared to baseline after MRG-001 injection. degree of hematopoietic stem cell mobilization (CD34+, cells/μl) measured as a longitudinal outcome over the first 24 hours after after MRG-001 injection.
Measured: 24 Hours
Organ Failure
The primary safety endpoint is organ system failure free days to day 28. Patients will be monitored daily for 28 days for signs of the failure of non-pulmonary organs and systems. The following non-pulmonary organ system failures will be assessed: circulatory, coagulation, hepatic and renal failure.
Measured: 28 Days
Secondary outcomes (5)
Pharmacokinetics
Change in the trough concentration (Ctrough) of tacrolimus in ng/mL in whole blood during the course of treatment.
Measured: 28 Days
Pharmacokinetics
Change in the trough concentration (Ctrough) of plerixafor in ng/mL in plasma during the course of treatment.
Measured: 28 Days
Pharmacodynamics
Change in absolute numbers or percentages from baseline in circulating stem cells and immune cells measured by flow cytometry
Measured: 28 Days
Cytokine Changes
Change from baseline in serum cytokines including IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-17, IL-18, IFN- γ, TNF-α.
Measured: 28 Days
Respiratory-Free Days
The number of days patients in the ICU do not require supplemental forms of oxygen.
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Jul 2026 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedRegen LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University Medical Center
- Responsible party
- Sponsor
- Investigators
- Gordon R Bernard, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308926
- Sponsor's protocol ID
- MRG23ARDS
- Acronym
- SUMMIT
- Status last verified
- Aug 2024
- First submitted
- 18 Dec 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahmadi AR, Atiee G, Chapman B, Reynolds L, Sun J, Cameron AM, Wesson RN, Burdick JF, Sun Z. A phase I, first-in-human study to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of MRG-001 in healthy subjects. Cell Rep Med. 2023 Sep 19;4(9):101169. doi: 10.1016/j.xcrm.2023.101169. Epub 2023 Aug 25.
PubMed 37633275
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Double-Blind, Randomized, Multi-Center Study Comparing MRG-001 to Placebo in Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT06308926
- Acronym / sponsor ID
- SUMMIT / MRG23ARDS
- Conditions
- Acute Respiratory Distress Syndrome, Respiratory Failure, Respiratory Distress Syndrome, Respiratory Tract Diseases, Cytokine Storm
- Keywords
- Acute Respiratory Distress Syndrome, MRG-001, Stem Cells, Immunomodulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- MedRegen LLCIndustry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University Medical Center
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 13 Mar 2024 (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.
This is a phase IIa, dose-ranging, proof-of-concept study of MRG-001 in patients with ARDS.
The aim is to determine the safety and preliminary efficacy of MRG-001 across two dose ranges.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MRG-001 (Low-dose) | Experimental | Drug: MRG-001 (Low-dose)MRG-001 will be administered subcutaneously at 0.007 mL/kg. Patients will receive 3 injections per week every other day for a total of 2 weeks or until discharge from the ICU. |
| MRG-001 (High-dose) | Experimental | Drug: MRG-001 (High-dose)MRG-001 will be administered subcutaneously at 0.01 mL/kg. Patients will receive 3 injections per week every other day for a total of 2 weeks or until discharge from the ICU. |
| Placebo | Placebo comparator | Other: PlaceboSterile injectable saline will be administered subcutaneously at 0.01 mL/kg. Patients will receive 3 injections per week every other day for a total of 2 weeks or until discharge from the ICU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute Respiratory Distress Syndrome, manifested by the following and not explained by alternative diagnoses, for example but not limited to: Pulmonary Edema due to Congestive Heart Failure (CHF).
- Chest x-ray (CXR)* revealing bilateral infiltrates involving a minimum of three quadrants on frontal chest radiograph, consistent with pulmonary edema or bilateral ground glass opacities not fully explained by effusions, lobar or lung collapse, nodules, atelectasis or other etiology of infiltrates not due to ARDS.
- PaO2/FiO2 < 300.
- Requiring respiratory support [defined as mechanical ventilation, non-invasive ventilation (NIV) or high flow nasal canula (HFNC)] If on ventilator, settings must include positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) ≥5 cm H2O.
Key exclusion criteria (15 listed)
- Age less than 18 years.
- Infiltrates with etiology suspected of mimicking ARDS, ie; Pulmonary Edema due to Congestive Heart Failure (CHF). (A Pulmonary Arterial Wedge Pressure (PAWP) of < 18 for >12 hours would rule out suspected CHF).
- Pregnancy documented or suspected in women of child bearing potential, unless ruled out by a negative pregnancy test during screening or breast feeding.
- Immunocompromised patients:
- 4.1. Organ or bone marrow transplant recipients and/or recent (within 2 months) chronic use of immunosuppressive drugs (tacrolimus, mycofenolate mofetil, cyclosporine, rapamycine, hydrochloroquine, azathiopurine, methotrexate), e.g., biologicals, JAK1/2 inhibitors, interferons, interleukins, (prednisone or related corticosteroids are allowed).
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 |
|---|---|---|
| MRG-001 (Low-dose)MRG-001 is subcutaneously administered. | Drug | MRG-001 (Low-dose) |
| MRG-001 (High-dose)MRG-001 is subcutaneously administered. | Drug | MRG-001 (High-dose) |
| PlaceboSaline placebo will be administered subcutaneously based on bodyweight and similar dose as the treatment group. | Other | Placebo |
Primary outcome
Hemopoietic stem cell mobilization
Time frame: 24 Hours
The primary efficacy endpoint is the absolute change of hematopoietic stem cell mobilization (CD34+ cells) calculated as cells/μl at the peak of mobilization at 12 hours compared to baseline after MRG-001 injection. degree of hematopoietic stem cell mobilization (CD34+, cells/μl) measured as a longitudinal outcome over the first 24 hours after after MRG-001 injection.
Organ Failure
Time frame: 28 Days
The primary safety endpoint is organ system failure free days to day 28. Patients will be monitored daily for 28 days for signs of the failure of non-pulmonary organs and systems. The following non-pulmonary organ system failures will be assessed: circulatory, coagulation, hepatic and renal failure.
5 secondary outcomes
Pharmacokinetics
Time frame: 28 Days
Pharmacokinetics
Time frame: 28 Days
Pharmacodynamics
Time frame: 28 Days
Cytokine Changes
Time frame: 28 Days
Respiratory-Free Days
Time frame: 28 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Results publication: PubMed 37633275Ahmadi AR, Atiee G, Chapman B, Reynolds L, Sun J, Cameron AM, Wesson RN, Burdick JF, Sun Z. A phase I, first-in-human study to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of MRG-001 in healthy subjects. Cell Rep Med. 2023 Sep 19;4(9):101169. doi: 10.1016/j.xcrm.2023.101169. Epub 2023 Aug 25.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Gordon R Bernard, MD principal investigator
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MRG-001 (Low-dose) and MRG-001 (High-dose) in people with Acute Respiratory Distress Syndrome and Respiratory Failure, run by MedRegen LLC.
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 4 inclusion and 15 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 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact MedRegen LLC (4437598563, info@medregenco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemopoietic stem cell mobilization (time frame: 24 Hours). The study lists 2 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 NCT06308926, 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 23 Aug 2024.