Safety Evaluation of Intramuscular Injections of PLX-R18 in Subjects With Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation

Phase 1 Completed 21 enrolled Pluristem Ltd.

NaSingle-groupOpen-labelTreatment

Summary

This study aims to evaluate the safety of intramuscular (IM) administration of PLX-R18 in subjects with incomplete hematopoietic recovery following HCT.

Timeline

Start: 2017-02-08
Primary completion: 2021-09-30
Completion: 2021-10-30

Publications

McGuirk JP, Metheny L 3rd, Pineiro L, Litzow M, Rowley SD, Avni B, Tamari R, Lazarus HM, Rowe JM, Sheleg M, Rothenstein D, Halevy N, Zuckerman T. Placental expanded mesenchymal-like cells (PLX-R18) for poor graft function after hematopoietic cell transplantation: A phase I study. Bone Marrow Transplant. 2023 Nov;58(11):1189-1196. doi: 10.1038/s41409-023-02068-3. Epub 2023 Aug 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PDA001	Cell therapy	1e+06 cells/kg	Intramuscular
Subject	PDA001	Cell therapy	2e+06 cells/kg	Intramuscular
Subject	PDA001	Cell therapy	4e+06 cells/kg	Intramuscular

Safety Evaluation of Intramuscular Injections of PLX-R18 in Subjects With Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation

Summary

Timeline

Publications

Drugs

Indications