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

NCT04909879 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: MSC-ARDS-201
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Respiratory Distress Syndrome; Ards

Keywords

ARDS

Outcome Measures

Primary Outcomes (1)

• All-cause mortality rate at Day 28

  All-cause mortality rate at Day 28

  Baseline to Day 28

Secondary Outcomes (5)

• All-cause mortality rate at Days 60 and 90

  Baseline to Day 60 and Day 90

• Number of ventilator-free days through Day 28

  Baseline through Day 28

• Number of ICU days through Day 28

  Baseline through Day 28

• Clinical status at Day 28

  Baseline to Day 28

• Change in oxygenation

  Baseline to Day 2, Day 4, Day 6, Day 14, Day 28

Study Arms (2)

COVI-MSC

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4

Drug: Placebo

Interventions

COVI-MSC BIOLOGICAL

COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells

COVI-MSC

Placebo DRUG

Excipient solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

MeSH Terms

Conditions

Respiratory Distress Syndrome; Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Study Officials

• Mike Royal, MD

  Sorrento Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2021
• First Posted: June 2, 2021
• Study Start: September 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: April 1, 2022
• Last Updated: September 24, 2021

Record last verified: 2021-09