Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654193
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Allogeneic HB-adMSCs vs Placebo for the Treatment of Acute Kidney Injury
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Allogeneic Adipose-derived Mesenchymal Stem Cells MSC for Acute Kidney Injury After Trauma or Burn
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 study is a multi-center prospective randomized double-blind placebo-controlled pragmatic Phase 1Phase 2a study of 3 infusions of allogeneic adipose-derived MSCs daily for 3 days in patients with modified KDIGO Stage 2 AKI This trial will enroll severely injured trauma or burn patients who have developed Stage 2 AKI Eligible patients will be randomized to receive Hope Biosciences HB-adMSCs or placebo administered within 24 hours of consent and in 3 doses each 24 hours apart Safety defined by infusional toxicity impact on duration and progression of AKI and determination of biomarkers of renal injury will be investigated in this trial 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None