Status:
WITHDRAWN
Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome
Lead Sponsor:
Sorrento Therapeutics, Inc.
Conditions:
Acute Respiratory Distress Syndrome
Ards
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 distres...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04909879
Start Date
September 1 2021
End Date
April 1 2022
Last Update
September 24 2021
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