amimestrocel (hUC-MSC PLEB001) / Platinumlife Biotech - LARVOL DELTA

Study on the effectiveness and safety of umbilical cord mesenchymal stem cell (Amimestrocel Injection) infusion in improving aging (ChiCTR) - P2 | N=2000 | Recruiting | Sponsor: Second Medical Center, Chinese PLA General Hospital; Second Medical Center, Chinese PLA General Hospital

New P2 trial

MSC-DKD-001: Safety and Efficacy of Mesenchymal Stromal Cells (Amimestrocel ) in Diabetic Kidney Disease (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Chinese PLA General Hospital | Trial primary completion date: May 2026 ➔ Aug 2026

Trial primary completion date • Diabetic Nephropathy • Nephrology • Renal Disease

MSC-AKI-001: Clinical Study to Evaluate the Efficacy and Safety of Mesenchymal Stromal Cells (Amimestrocel ) in Patients With Acute Kidney Injury (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Chinese PLA General Hospital | Trial primary completion date: May 2026 ➔ Aug 2026

Trial primary completion date • Acute Kidney Injury • Nephrology • Renal Disease

Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients (clinicaltrials.gov) - P2 | N=22 | Recruiting | Sponsor: The First Affiliated Hospital of Soochow University | Not yet recruiting ➔ Recruiting

Enrollment open • Bone Marrow Transplantation • Dental Disorders • Mucositis • Stomatitis • Transplantation

Mesenchymal stromal cells as add-on therapy to anti-CD25 antibodies for treating gastrointestinal-involved steroid-refractory acute graft-versus-host disease: a multicenter, single-arm, pivotal clinical trial. (PubMed, Stem Cell Res Ther) - P3 | "In this multicenter single-arm study, hUC-MSC PLEB001 plus anti-CD25 monoclonal antibody therapy was associated with clinically meaningful response rates and an acceptable safety profile in patients with SR-GI-aGVHD. These findings support further evaluation of MSC-based approaches within multimodal treatment algorithms for this challenging condition."

Journal • Acute Graft versus Host Disease • Bone Marrow Transplantation • Graft versus Host Disease • Immunology • Transplantation

Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients (clinicaltrials.gov) - P2 | N=22 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Soochow University

New P2 trial • Bone Marrow Transplantation • Dental Disorders • Mucositis • Stomatitis • Transplantation

Mesenchymal stem cells for treating gastrointestinal-involved steroid-refractory acute graft-versus-host disease: A multicenter, single-arm, pivotal clinical Trial (ASH 2025) - "This study suggests the efficacy and good tolerance of hUC-MSC PLEB001 in SR-GI-aGVHD patients, basedon which hUC-MSC PLEB001 (Amimestrocel) became the first approved MSC product by Chinese NMPA."

Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

MSC-DKD-001: Safety and Efficacy of Mesenchymal Stromal Cells (Amimestrocel ) in Diabetic Kidney Disease (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Chinese PLA General Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Nephropathy • Nephrology • Renal Disease

MSC-AKI-001: Clinical Study to Evaluate the Efficacy and Safety of Mesenchymal Stromal Cells (Amimestrocel ) in Patients With Acute Kidney Injury (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Chinese PLA General Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Kidney Injury • Nephrology • Renal Disease

MSC-DKD-001: Safety and Efficacy of Mesenchymal Stromal Cells (Amimestrocel ) in Diabetic Kidney Disease (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Chinese PLA General Hospital

New P2 trial • Diabetic Nephropathy • Nephrology • Renal Disease

MSC-AKI-001: Clinical Study to Evaluate the Efficacy and Safety of Mesenchymal Stromal Cells (Amimestrocel ) in Patients With Acute Kidney Injury (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Chinese PLA General Hospital

New P2 trial • Acute Kidney Injury • Nephrology • Renal Disease