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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 weeks
Treatment ~ Varies
Follow Up ~outcomes and serious adverse events through day 180
This trial's timeline: 3 weeks for screening, Varies for treatment, and outcomes and serious adverse events through day 180 for reporting.

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.

Find a Location

Who is running the clinical trial?

Sentien Biotechnologies, Inc.Lead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of Cell Therapy in COVID-19 Subjects With Acute Kidney Injury Who Are Receiving Renal Replacement Therapy
2020. "A Study of Cell Therapy in COVID-19 Subjects With Acute Kidney Injury Who Are Receiving Renal Replacement Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04445220.
All > Covid
~5 spots leftby Apr 2025
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