Has this trial been discussed? Seems to be stomping all over MSB Patents and a generation behind it seems to me as using unrefined bone morrow cells? If so hope they have designed this trial well so as to not stain MSB science? It's only a phase 2 safety trial however we don't want negative outcomes from I'll designed from come lately's!
SI and legal team probably all over it?
Trial record 3 of 5 for:MSC | Recruiting Studies | ARDS | United States Previous Study | Return to List | Next Study Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (STAT)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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ClinicalTrials.gov Identifier: NCT03818854
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Recruitment Status : RecruitingFirst Posted : January 28, 2019Last Update Posted : March 31, 2020See Contacts and Locations
Sponsor:
Michael A. Matthay
Collaborators:
United States Department of Defense
Harborview Injury Prevention and Research Center
Oregon Health and Science University
Vanderbilt University Medical Center
The University of Texas Health Science Center, Houston
University of Minnesota
Information provided by (Responsible Party):
Michael A. Matthay, University of California, San Francisco
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Brief Summary:
This is a Phase 2b, randomized, double-blind, placebo-controlled, multi-center study to assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) infusion in patients with Acute Respiratory Distress Syndrome (ARDS). This study is the extension of the Phase 1 pilot study (NCT01775774) and Phase 2a study (NCT02097641).
Condition or disease
Intervention/treatment
Phase
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Respiratory Distress Syndrome, Adult
Biological: Human Mesenchymal Stromal CellsBiological: Cell Reconstitution Media
Phase 2
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mce-anchorDetailed Description:
This clinical study design is a randomized, double-blinded, placebo-controlled Phase 2b clinical trial using a 10 million cell/kg dose of human Mesenchymal Stromal Cells (hMSCs). Subjects will be randomized in a 1:1 randomization scheme to receive hMSCs or cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) as the placebo; the study will enroll 120 patients who achieve a stable clinical baseline and receive study product (either hMSCs or the placebo).
The Data and Safety Monitoring Board (DSMB) will review adverse outcomes and protocol compliance. A pre-specified interim review will occur after 60 subjects have been enrolled and received study product; enrollment will continue during the DSMB review. All pre-specified clinically important events and unexpected serious adverse events including death during hospitalization up to 60 days will be reported to the DSMB on an ongoing basis; the study will be stopped for a safety evaluation by the DSMB if they have any concerns or if three subjects have pre-specified clinically important events or unexpected serious adverse events except death since death will be common in this critically ill population due the nature of the underlying illness (e.g., ARDS).
mce-anchorStudy Design
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Study Type :
Interventional (Clinical Trial)
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Estimated Enrollment :
120 participants
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Allocation:
Randomized
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Intervention Model:
Parallel Assignment
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Intervention Model Description:
For this Phase 2b trial, after informed consent is given, an assignment will be made by computer-generated randomization to administer either hMSCs therapy or placebo with a 1:1 allocation to the hMSCslacebo arms.
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Masking:
Triple (Participant, Care Provider, Investigator)
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Primary Purpose:
Treatment
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Official Title:
A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) for the Treatment of Acute Respiratory Distress Syndrome
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Actual Study Start Date :
November 26, 2019
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Estimated Primary Completion Date :
July 1, 2023
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Estimated Study Completion Date :
July 1, 2024
Resource links provided by the National Library of Medicine
Experimental: Human Mesenchymal Stromal CellsA single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes.
Biological: Human Mesenchymal Stromal CellsImmediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.Other Name: hMSCs
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Experimental: Cell Reconstitution MediaA single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes.
Biological: Cell Reconstitution Media300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)Other Name: Placebo
mce-anchorOutcome Measures
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Primary Outcome Measures :
Change in oxygenation index (OI) [ Time Frame: 36 hours ]
Change in OI from baseline over the 36 hours following the infusion of study product
Secondary Outcome Measures :
Acute Lung Injury Score (LIS) [ Time Frame: 7 days ]
LIS over 7 days, or on the last day of positive pressure ventilation prior to day 7. The LIS is a composite 4-point scoring system including the PaO2/FiO2, PEEP, lung compliance, and the extent of infiltrates on the chest X-ray. Each of the four components is categorized from 0 to 4, where a higher number is worse. The total Lung Injury Score is obtained by dividing the aggregate sum by the number of components used.
Pulmonary Dead Space Fraction [ Time Frame: 7 days ]
Pulmonary Dead Space at day 1, 2, 3 and 7. The dead-space fraction is calculated as: (PaCO2 - PeCO2) ÷ PaCO2
Chest radiograph assessment of pulmonary edema (RALE score) [ Time Frame: 7 days ]
RALE score at day 1, 2, 3 and 7. To calculate RALE, each radiographic quadrant is scored for extent of consolidation (0-4) and density of opacification (1-3). The product of the consolidation and density scores for each of the four quadrants is summed. The RALE score ranges from 0 (best) to 48 (worst).
Ventilator free-days [ Time Frame: 28 days ]
Ventilator free-days over 7, 14 and 28 days
Duration of assisted ventilation over 28 days [ Time Frame: 28 days ]
Duration of assisted ventilation over 28 days in the survivors
Percentage of patients achieving pressure support ventilation for 2 hours [ Time Frame: 28 days ]
Percentage of patients achieving pressure support ventilation equal to 5 cm H2O with positive end-expiratory pressure (PEEP) equal to 5 cm H2O for 2 hours
Occurrence of Infection [ Time Frame: 14 days ]
Superficial incisional/wound infections, deep incisional wound infections, and organ/space infections, and ventilator associated pneumonia (all during the 14 days after enrollment)
Sequential Organ Failure Assessment (SOFA) [ Time Frame: 7 days ]
SOFA score at 3 and 7 days. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems which are added up. Each score ranges from 0 to 4. SOFA score ranges from 0 (best) to 24 (worst).
All-cause hospital mortality [ Time Frame: 60 days ]
All-cause hospital mortality at 14, 28 and 60 days
Glasgow Outcome Score (GCS) [ Time Frame: 60 days ]
Glasgow Outcome Score at hospital discharge. The GCS is a scale to evaluate level of consciousness in patients with acute brain injury. The scale assesses 3 functions: Eye Opening, Verbal Response, and Motor Response. GCS scores range from 15 (best) to 3 (worst)
Percentage of patients occurred any thromboembolic events [ Time Frame: 60 days ]
Thromboembolic events are measured by ultrasound of the deep venous system or CT-angiography of the chest ordered for clinical purposes/by treating clinicians
Plasma angiopoietin-2 [ Time Frame: 72 hours ]
Change in levels of plasma angiopoietin-2 from baseline compared to 6, 24, 48 and 72 hours
Plasma Receptor for Advanced Glycation Endproducts (RAGE) [ Time Frame: 72 hours ]
Change in levels of plasma RAGE from baseline compared to 6, 24, 48 and 72 hours
Plasma interleukin-6 [ Time Frame: 72 hours ]
Change in levels of plasma interleukin-6 from baseline compared to 6, 24, 48 and 72 hours
Plasma interleukin-8 [ Time Frame: 72 hours ]
Change in levels of plasma interleukin-8 from baseline compared to 6, 24, 48 and 72 hours
Plasma Soluble tumor necrosis factor 1 (sTNF-1) [ Time Frame: 72 hours ]
Change in levels of plasma sTNF-1 from baseline compared to 6, 24, 48 and 72 hours
Plasma protein C [ Time Frame: 72 hours ]
Change in levels of plasma protein C from baseline compared to 6, 24, 48 and 72 hours
Plasma lipoxin A4 [ Time Frame: 72 hours ]
Change in levels of plasma lipoxin A4 from baseline compared to 6, 24, 48 and 72 hours
Plasma Resolvin D1 [ Time Frame: 72 hours ]
Change in levels of plasma Resolvin D1 from baseline compared to 6, 24, 48 and 72 hours
Plasma angiopoietin-1 [ Time Frame: 72 hours ]
Change in levels of plasma angiopoietin-1 from baseline compared to 6, 24, 48 and 72 hours
Plasma keratinocyte growth factor (KGF) [ Time Frame: 72 hours ]
Change in levels of plasma KGF from baseline compared to 6, 24, 48 and 72 hours
Urine microalbumin [ Time Frame: 48 hours ]
Change in levels of urine microalbumin from baseline compared to 24 and 48 hours
Total protein in min-bronchoalveolar lavage (mBAL) [ Time Frame: 2 days ]
Change in total protein levels in from baseline to day 2
Tolerability of the hMSCs - incidence of pre-specified infusion-associated events and unexpected severe adverse events [ Time Frame: 24 hours ]
Tolerability of the hMSCs, defined as the incidence of pre-specified infusion-associated events and unexpected severe adverse events in ARDS patients treated with human Mscs
lacebo arms.
(20min delay)