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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Recruitment Status : Withdrawn (Replaced by a different protocol.)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.

Tracking Information
First Submitted Date  ICMJE May 29, 2021
First Posted Date  ICMJE June 2, 2021
Last Update Posted Date September 24, 2021
Estimated Study Start Date  ICMJE September 2021
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2021)
All-cause mortality rate at Day 28 [ Time Frame: Baseline to Day 28 ]
All-cause mortality rate at Day 28
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2021)
  • 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
  • Number of ventilator-free days through Day 28 [ Time Frame: Baseline through Day 28 ]
    Number of ventilator-free days through Day 28
  • Number of ICU days through Day 28 [ Time Frame: Baseline through Day 28 ]
    Number of ICU days through Day 28
  • 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)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Respiratory Distress Syndrome
  • Ards
Intervention  ICMJE
  • Biological: COVI-MSC
    COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
  • Drug: Placebo
    Excipient solution
Study Arms  ICMJE
  • 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
    Intervention: Biological: COVI-MSC
  • Placebo Comparator: Placebo
    Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 17, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2021)
100
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04909879
Other Study ID Numbers  ICMJE MSC-ARDS-201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sorrento Therapeutics, Inc.
Study Sponsor  ICMJE Sorrento Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mike Royal, MD Sorrento Therapeutics, Inc.
PRS Account Sorrento Therapeutics, Inc.
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP