Stem Cells for Acute Kidney Injury
(AKI Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byCharles S Cox, Jr., MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Hope Biosciences

Trial Summary

What is the purpose of this trial?This study aims to investigate, through the collection of valid scientific evidence necessary to determine safety and effectiveness, the potential use of Allogeneic Hope Biosciences Adipose-derived Mesenchymal Stem Cells (HB-adMSCs) to prevent progression of trauma-induced Acute Kidney Injury (AKI).

Eligibility Criteria

This trial is for individuals with trauma-induced Acute Kidney Injury (AKI). Specific eligibility criteria are not provided, but typically participants must meet certain health conditions and cannot have factors that would exclude them from safely participating.

Inclusion Criteria

Expected to survive at least 24 hours after diagnosis of KDIGO Stage 2 AKI

Patient or patient's legally authorized representative (LAR) has voluntarily signed the informed consent

I am between 18 and 75 years old.

+3 more

Exclusion Criteria

Known Do Not Resuscitate (DNR) prior to randomization

Known allergy to dimethyl sulfoxide or human serum albumin

Pregnant and lactating females due to unknown effects of stem cells on developing fetus or milk

+10 more

Participant Groups

The study is testing the safety and effectiveness of Allogeneic HB-adMSCs, which are stem cells derived from adipose tissue, compared to a placebo (normal saline) in preventing the progression of AKI following trauma.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

Allogeneic adipose-derived HB-adMSCs

Group II: PlaceboPlacebo Group1 Intervention

Normal saline