Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT06654193
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2024-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Allogeneic HB-adMSCs vs Placebo for the Treatment of Acute Kidney Injury
Sponsor:
Hope Biosciences LLC
Organization:
Study Overview
Official Title:
Allogeneic Adipose-derived Mesenchymal Stem Cells (MSC) for Acute Kidney Injury After Trauma or Burn
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AKI
Brief Summary:
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).
Detailed Description:
This trial multicenter, prospective, randomized, double-blind, placebocontrolled pragmatic Phase 1/Phase 2a clinical study aims to investigate, through the collection of valid scientific evidence necessary to determine safety and effectiveness, the potential use of adiposederived allogenic MSCs to prevent progression of trauma-induced AKI. We hypothesize that infusing a total of 3 doses of MSCs over 72 hours at 24-hour intervals starting in patients with modified KDIGO Stage 2 or 3 AKI will prove to be safe and efficacious.
Phase 1 of the study will include Cohort 1 (10 patients) and will confirm safety in this population with this cell formulation (cryopreserved and reanimated). Phase 2a of the study will include 60 patients (30 interventional, 30 placebo) and will look at duration of AKI at Stage 2 or higher (defined as proportion of patients with a duration of Stage 2 AKI more than 2 days after the start of treatment).
Phase 1 of the study will include Cohort 1 (10 patients) and will confirm safety in this population with this cell formulation (cryopreserved and reanimated). Phase 2a of the study will include 60 patients (30 interventional, 30 placebo) and will look at duration of AKI at Stage 2 or higher (defined as proportion of patients with a duration of Stage 2 AKI more than 2 days after the start of treatment).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: