Allogeneic HB-adMSCs vs Placebo for the Treatment of Acute Kidney Injury

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Hope Biosciences LLC
Study ID
NCT06654193
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Acute Kidney Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Allogeneic HB-adMSCs — DRUG
    Allogeneic HB-adMSCs
  • Normal Saline — DRUG
    Sterile Saline Solution

Study Details

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).

Key Dates

Start date
Feb 1, 2026
Status verified
Mar 2026
Primary completion
Jan 1, 2028
Completion
Jan 1, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Normal saline
  • Experimental: Treatment
    Allogeneic adipose-derived HB-adMSCs

Primary Outcome Measure

Incidence of infusion-related adverse events (AEs) or serious adverse events (SAEs) [ Time Frame: 1 year ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Sabrina Goddard, MD
Sabrina Goddard, MD (PRINCIPAL_INVESTIGATOR)
John B Holcomb, MD (SUB_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94143
Joseph Cuschieri, MD
Joseph Cuschieri, MD (PRINCIPAL_INVESTIGATOR)
Shibani Pati, MD, PhD (PRINCIPAL_INVESTIGATOR)
Kathleen Liu, MD, PhD (SUB_INVESTIGATOR)
Lucy Kornblith, MD (SUB_INVESTIGATOR)
University of Texas Health Science Center at Houston (UTHealth Houston)HoustonTexas77479
Charles S Cox, Jr., Dr.
[email protected]
713-500-7307
Charles S Cox, Jr., Dr. (PRINCIPAL_INVESTIGATOR)
Erin E Fox, PhD (SUB_INVESTIGATOR)
John Harvin, MD, MS (SUB_INVESTIGATOR)
Laura Moore, MD (SUB_INVESTIGATOR)
Claudia Pedroza, PhD (SUB_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of California, San Francisco· San Francisco, CAUniversity of Texas Health Science Center at Houston (UTHealth Houston)· Houston, TX

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