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

Sponsor
Sorrento Therapeutics, Inc. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04909879
Collaborator
(none)
0
2
7

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
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
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. All-cause mortality rate at Day 28 [Baseline to Day 28]

    All-cause mortality rate at Day 28

Secondary Outcome Measures

  1. All-cause mortality rate at Days 60 and 90 [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 [Baseline through Day 28]

    Number of ventilator-free days through Day 28

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

    Number of ICU days through Day 28

  4. Clinical status at Day 28 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sorrento Therapeutics, Inc.

Investigators

  • Study Director: Mike Royal, MD, Sorrento Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sorrento Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT04909879
Other Study ID Numbers:
  • MSC-ARDS-201
First Posted:
Jun 2, 2021
Last Update Posted:
Sep 24, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sorrento Therapeutics, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 24, 2021