NCT06678399View on ClinicalTrials.gov

Phase 1B/2 Clinical Trial Assessing the Safety, Tolerability and Preliminary Efficacy of the Intravenous Administration of Allogeneic Placental Mesenchymal Cells for the Preemptive Treatment of Patients At Risk for Acute Kidney Injury Following Cardiac Surgery

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

91

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

October 1, 2026

Study Completion Date

January 1, 2027

Conditions
Preemptive Therapy of Patients At Risk for Acute Kidney Injury Following Cardiac Surgery
Interventions
DRUG

KELI-101

KELI-101 consists of ex vivo expanded placental mesenchymal stromal cells (PMSCs) in a 10% cryopreservation solution.

OTHER

Vehicle (placebo)

Plasmalyte

Sponsors

Lead Sponsor

Kelifarma
All Listed Sponsors
lead

Kelifarma

INDUSTRY

NCT06678399 - Phase 1B/2 Clinical Trial Assessing the Safety, Tolerability and Preliminary Efficacy of the Intravenous Administration of Allogeneic Placental Mesenchymal Cells for the Preemptive Treatment of Patients At Risk for Acute Kidney Injury Following Cardiac Surgery | Biotech Hunter | Biotech Hunter