Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration (REALIST) (REALIST)
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|ClinicalTrials.gov Identifier: NCT03042143|
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : January 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress Syndrome||Biological: Human umbilical cord derived CD362 enriched MSCs Biological: Placebo (Plasma-Lyte 148)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
The phase 1 trial is an open label dose escalation pilot study in which cohorts of subjects with moderate to severe ARDS will receive increasing doses of a single infusion of Realist Orbcel-C in a 3+3 design. Initially 3 cohorts with 3 subjects/cohort.
After 7 days of follow-up for all study subjects in the phase 1 study is available the TMG will review the data and propose a cell dose for the phase 2 trial. This recommendation will be submitted to the DMEC for approval prior to initiating the phase 2 trial.
The phase 2 trial is a randomized, double-blind, allocation concealed placebo-controlled study using the maximal tolerable dose as determined by the DMEC in patients with moderate to severe ARDS.
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
The cell therapy facility and clinical trials pharmacist will be unblinded. The unblinded individuals will keep the treatment information confidential and will not discuss or release information on treatment allocation to the patient, the investigator, or other unauthorized personnel.
As in prior studies of MSCs, the infusion bag containing either the cell product or placebo will be masked at the time of preparation in the clinical site's cell therapy facility so that the contents of the infusion bag are not visible to the investigators or to the clinicians who are administering the study drug. The contents of the infusion bag will be administered through a masked infusion set.
|Official Title:||Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration (REALIST): An Open Label Dose Escalation Phase 1 Trial Followed by a Randomized, Double-blind, Placebo-controlled Phase 2 Trial|
|Actual Study Start Date :||January 7, 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||October 2022|
Experimental: Human umbilical cord derived CD362 enriched MSCs
Maximum tolerated dose from the phase 1 trial will be infused over 30 to 90 mins
Biological: Human umbilical cord derived CD362 enriched MSCs
Infusion of Human umbilical cord derived CD362 enriched MSCs
Placebo Comparator: Placebo (Plasma-Lyte 148) infusion
Plasma-Lyte 148 infused over 30 to 90 mins
Biological: Placebo (Plasma-Lyte 148)
Infusion of placebo
- Oxygenation index (OI) [ Time Frame: Day 7 ]OI is a physiological index of the severity of ARDS and measures both impaired oxygenation and the amount of mechanical ventilation delivered
- Incidence of Serious Adverse Events (SAEs) [ Time Frame: 28 days ]Incidence of SAEs
- Oxygenation index [ Time Frame: Days 4 and 14 ]
- Sequential Organ Failure Assessment (SOFA) score [ Time Frame: Days 4, 7 and 14 ]SOFA score is a measure of organ failure
- Respiratory compliance (Crs) [ Time Frame: Days 4, 7 and 14 ]Crs is a physiological measure of pulmonary function in ARDS
- Partial pressure of arterial oxygen to the fraction of inspired oxygen ratio (P/F ratio) [ Time Frame: Days 4, 7 and 14 ]P/F ratio is a physiological measure of pulmonary function in ARDS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042143
|Contact: Danny F McAuley, MDfirstname.lastname@example.org|
|Contact: Cecilia O'Kane, Ph.Demail@example.com|
|Principal Investigator:||Danny F McAuley, Professor||Belfast Health and Social Care Trust|