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Mesenchymal Stem Cells

COVI-MSC for Coronavirus

Phase 2

Waitlist Available

Research Sponsored by Sorrento Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 14 day 28, and day 60

Awards & highlights

Study Summary

This trial is testing a new treatment for COVID-19 that uses stem cells.

Eligible Conditions

Coronavirus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 14 day 28, and day 60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 14 day 28, and day 60

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 14 day 28, and day 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

All-cause mortality rate at Day 28

Incidence of all adverse events (AEs) (safety)

Incidence of infusion-related adverse events (safety)

+2 more

Secondary outcome measures

All-cause mortality rate at Day 60 and 90

Change in clinical status

Change in oxygenation

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: COVI-MSCExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sorrento Therapeutics, Inc.Lead Sponsor

47 Previous Clinical Trials

1,904 Total Patients Enrolled

Mike Royal, MDStudy DirectorSorrento Therapeutics, Inc.

27 Previous Clinical Trials

1,435 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there multiple healthcare facilities enacting this investigation in the same jurisdiction?

"There are 6 clinical trial sites presently enrolling patients, including Ascension St. John in Tulsa, St Luke's Research in Mesquite, and PRX Research/Dallas Regional Medical Center in Sarasota."

Answered by AI

What results is this trial striving to achieve?

"According to the study sponsor, Sorrento Therapeutics, Inc., their primary endpoint is the rate of adverse events (AEs) from Baseline through Day 28. Additional safety assessments include mortality rates at Days 60 and 90, frequency of infusion-related serious AE's over 4 hours post-administration, as well as a review of AESI's (Adverse Events of Special Interest)."

Answered by AI

Has COVI-MSC achieved formal authorization from the Food and Drug Administration?

"With some clinical evidence of safety but no data yet on efficacy, the risk assessment for COVI-MSC was rated a 2 out of 3."

Answered by AI

What is the cap on enrollment for this research project?

"In order for the trial to commence, Sorrento Therapeutics Inc. must acquire 60 participants that meet their criteria from multiple sites, such as Ascension St. John in Tulsa, Oklahoma and St Luke's Research in Mesquite, Texas."

Answered by AI

Does this clinical experiment have any vacancies available?

"Confirmed. Clinicaltrials.gov states that this clinical trial is seeking applicants, with the original posting date being November 16th 2021 and the last update occurring on April 7th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treatment of COVID-19 Acute Respiratory Distress". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04905836.