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Cell Therapy
SBI-101 for Sepsis
Phase 1 & 2
Waitlist Available
Research Sponsored by Sentien Biotechnologies, 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 outcomes and serious adverse events through day 180
Awards & highlights
Study Summary
This trial is testing a new product, SBI-101, to see if it is safe and effective in treating patients with a kidney infection. SBI-101 is a combination of a biologic and a device that is designed to reduce inflammation and help repair damaged tissue. Patients will be treated with SBI-101 for up to 24 hours.
Eligible Conditions
- Sepsis
- Acute Kidney Injury
- Coronavirus
- COVID-19
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ outcomes and serious adverse events through day 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~outcomes and serious adverse events through day 180
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability as measured by incidence of IP-related serious adverse events
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Low dose cohortExperimental Treatment1 Intervention
SBI-101 device containing 250 million MSCs
Group II: High dose cohortExperimental Treatment1 Intervention
SBI-101 device containing 750 million MSCs
Group III: Case controlsActive Control1 Intervention
Case control subjects will receive only standard-of-care treatment and will be followed for the same safety assessments as active study participants.
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Who is running the clinical trial?
Sentien Biotechnologies, Inc.Lead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
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