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Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome

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ClinicalTrials.gov Identifier: NCT04909879
Recruitment Status : Withdrawn (Replaced by a different protocol.)
First Posted : June 2, 2021
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

Brief Summary:
This is a Phase 2 randomized study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for subjects hospitalized subjects with acute respiratory distress syndrome not related to COVID-19 infection.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Ards Biological: COVI-MSC Drug: Placebo Phase 2

Detailed Description:

This is a Phase 2, randomized controlled, multicenter study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for subjects hospitalized subjects with acute respiratory distress syndrome not related to COVID-19 infection.

Subjects will be randomized 2:1 to receive COVI-MSC or placebo. COVI-MSC or placebo will be administered intravenously on Day 0, Day 2, and Day 4.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Non-COVID-19 Acute Respiratory Distress Syndrome: A Phase 2 Study of the Efficacy and Safety of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : April 2022


Arm Intervention/treatment
Experimental: COVI-MSC
Subjects will receive intravenous infusions of COVI-MSC (two vials or a total of ≈ 30 million cells) on Day 0, Day 2, and Day 4
Biological: COVI-MSC
COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells

Placebo Comparator: Placebo
Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4
Drug: Placebo
Excipient solution




Primary Outcome Measures :
  1. All-cause mortality rate at Day 28 [ Time Frame: Baseline to Day 28 ]
    All-cause mortality rate at Day 28


Secondary Outcome Measures :
  1. All-cause mortality rate at Days 60 and 90 [ Time Frame: Baseline to Day 60 and Day 90 ]
    All-cause mortality rate at Days 60 and 90

  2. Number of ventilator-free days through Day 28 [ Time Frame: Baseline through Day 28 ]
    Number of ventilator-free days through Day 28

  3. Number of ICU days through Day 28 [ Time Frame: Baseline through Day 28 ]
    Number of ICU days through Day 28

  4. Clinical status at Day 28 [ Time Frame: Baseline to Day 28 ]
    Clinical status as assessed using the Ordinal Scale for Clinical Improvement (0-8 scale, where lower score means better outcome)

  5. Change in oxygenation [ Time Frame: Baseline to Day 2, Day 4, Day 6, Day 14, Day 28 ]
    Change in oxygenation at Days 2, 4, 6, 14, and 28 as measured using PaO2:FiO2 ratio.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Negative for SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
  • Hospitalized with non-COVID-19-induced ARDS (any severity) with a PaO2/FiO2 (PF ratio) ≤ 300
  • Requires oxygen supplementation at Screening
  • Willing to follow contraception guidelines

Exclusion Criteria:

  • Current standard of care treatments for ARDS appear to be working and the subject is clinically improving
  • A previous stem cell infusion unrelated to this trial
  • Pregnant or breast feeding or planning for either during the study
  • Suspected uncontrolled active bacterial, fungal, viral, or other infection
  • History of a splenectomy, lung transplant or lung lobectomy
  • Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
  • Expected survival or time to withdrawal of life-sustaining treatments expected to be < 7 days

Information from the National Library of Medicine

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): NCT04909879


Sponsors and Collaborators
Sorrento Therapeutics, Inc.
Investigators
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Study Director: Mike Royal, MD Sorrento Therapeutics, Inc.
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Responsible Party: Sorrento Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04909879    
Other Study ID Numbers: MSC-ARDS-201
First Posted: June 2, 2021    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sorrento Therapeutics, Inc.:
ARDS
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury