A Phase I Study of PLX-R18 in People with Incomplete Recovery After Stem Cell Transplantation

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Full Title

Phase I Open-label Dose-escalation Study to Evaluate the Safety of Intramuscular Injections of PLX-R18 in Subjects with Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation

Purpose

The purpose of this study is to assess the safety of the investigational treatment PLX-R18 in people who have had a stem cell transplant and whose blood-counts have not yet returned to normal levels. PLX-R18 is a cellular therapy; it contains living cells from a human donor that are injected into the body. The living cells come from placentas (collected after birth, with no harm to the mother or baby) donated by healthy female donors.

PLX-R18 was designed to produce proteins called cytokines that help blood-forming cells make new blood cells. Researchers think that PLX-R18 may help the body make more blood-forming cells, so patients could recover more quickly after a stem cell transplant. PLX-R18 is given as an intramuscular (into the muscle) injection.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be experiencing incomplete blood count recovery 3 or more months after a stem cell transplant.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Roni Tamari at 646-608-3738.

Protocol

19-421

Phase

I

Investigator

Co-Investigators