A spokesperson for the Israel-based Pluristem told us “we cannot comment on the name of the CRO, but the trial should begin enrolling in the next few months” after site staff training has been completed.
Pluristem's candidate cell therapy - knonw as PLX-R18 - is intended to treat patients who do not recover bone marrow function after transplants.
Hematopoietic cell transplantation (HCT) is used to treat patients who have lost bone marrow as a result of disease or radiotherapy. The aim is to replace the lost cells with those harvested from the individual prior to therapy or from a donor.
PLX-R18 consists of cells that consists of live cells that can sense chemical distress signals from bone marrow that has been damaged by radiation. In response they secrete proteins that support the regeneration of bone marrow and the recovery of its ability to produce normal blood cells.
The multi-center, open-label, dose-escalating Phase I trial will evaluate the safety of PLX-R18 injections in 30 patients with incomplete hematopoietic recovery persistent for 6 months or more after HCT.
Pluristem was cleared to begin a Phase I trial of PLX-R18 by the US Food and Drug Administration in March.
PLX-R18 is Pluristem’s second placental-derived cell therapy product in development, the other being PLX-PAD.
In 2013 Pluristem contracted South Korea-based CRO CHA Biotech to conducted trials of PLX-PAD in the treatment of critical limb ischemia and intermediate claudication.