hAESCs for GvHD / iCELL Biotechnology - LARVOL DELTA

NFEC-2019-128: hAESCs Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Nanfang Hospital, Southern Medical University | N=18 ➔ 0 | Trial completion date: Dec 2025 ➔ Jun 2028 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Jul 2025 ➔ Dec 2027

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Acute Graft versus Host Disease • Bone Marrow Transplantation • Graft versus Host Disease • Immunology • Transplantation

Metabolic reprogramming by itaconate: Haescs-derived therapy targets fibroblast GLUD1 to alleviate ocular graft versus host disease (ASH 2025) - "HAESCs secrete itaconic acid and inhibit the activation of fibroblasts into inflammation-associatedfibroblasts in ocGVHD, thereby reducing the secretion of PGE2 from PTGS2+ fibroblasts. This modulationsupports the restoration of LSC functionality, alleviates corneal inflammation, facilitates corneal repair,thus reducing ocGVHD."

Bone Marrow Transplantation • Chronic Graft versus Host Disease • Dry Eye Disease • Graft versus Host Disease • Immunology • Inflammation • Keratitis • Ocular Inflammation • Ophthalmology • IL17A • MMP2 • PACERR • PTGS2

HUMAN AMNIOTIC EPITHELIAL CELLS (HAECS) IS SAFE AND EFFECTIVE FOR STEROID REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE AFTER ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION: RESULTS OF A PHASE I STUDY (EHA 2025) - "The median time from diagnosis to hAESCs treatment was 0.5 (1 -55) days.; The MTD was not reached up to 3×106cell/kg dose... HAECs demonstrated no dose-limiting toxicities and achieved 100% ORR in SR-aGVHD. A phase study in SR-aGVHD is projected to start in Q4 0 5."

P1 data • Acute Graft versus Host Disease • Bone Marrow Transplantation • CNS Disorders • Epilepsy • Febrile Neutropenia • Graft versus Host Disease • Hematological Disorders • Hypoglycemia • Immunology • Infectious Disease • Neutropenia • Pneumonia • Respiratory Diseases • Transplantation

DUAL EFFECTS OF HUMAN AMNIOTIC EPITHELIAL STEM CELLS ON ANTI-INFLAMMATION AND FIBROSIS AND PROMOTING LIMBAL STEM CELL REGENERATION IN OCULAR CHRONIC GRAFT-VERSUS-HOST DISEASE (EBMT 2025) - P=N/A | "HAESCs inhibit the activation of fibroblasts into inflammation-associated fibroblasts in ocGVHD, thereby reducing the secretion of PGE2 by these cells. This modulation supports the restoration of LSC functionality, alleviates corneal inflammation, and facilitates corneal repair. Clinical Trial Registry: ChiCTR2200057857 (https://www.chictr.org.cn/showproj.html?proj=135963)"

Bone Marrow Transplantation • Chronic Graft versus Host Disease • Corneal Abrasion • Dry Eye Disease • Fibrosis • Graft versus Host Disease • Immunology • Inflammation • Keratitis • Ocular Inflammation • COL1A1 • MMP2 • PACERR • PTGS2

Human amniotic epithelial stem cell is a cell therapy candidate for preventing acute graft-versus-host disease. (PubMed, Acta Pharmacol Sin) - P=N/A | "We conclude that hAESCs infusion is a promising therapeutic strategy for post-HSCT GVHD without compromising the GVL effect. The clinical trial was registered at www.clinicaltrials.gov as #NCT03764228."

Journal • Acute Graft versus Host Disease • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • Transplantation • CD4 • TGFB1

aGVHD，hAESCs: Safety and Efficacy Study of hAESCs Therapy for aGVHD (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

New P1 trial • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology • Transplantation