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Open-label Phase I Study for PEP or Treatment of HS-ARS PLX-R18 for the Post-Exposure Prevention (PEP) or Treatment of Hematopoietic Syndrome of Acute Radiation Syndrome (HS-ARS)

NCT03797040 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-07-28

No results posted yet for this study

Summary

The objective of the study is to evaluate the safety of intramuscular (IM) administration of PLX-R18 in subjects exposed to ionizing radiation and who are at risk of developing HS-ARS.

Indication:Post-Exposure Prevention (PEP) or treatment of Hematopoietic Syndrome of Acute Radiation Syndrome (HS-ARS) in subjects suspected to have been exposed to ionizing radiation.

Conditions

  • Ionizing Radiation Exposure

Interventions

BIOLOGICAL

Cell therapy

PLX-R18: Allogeneic ex vivo expanded placental stromal cells

Sponsors & Collaborators

  • Pluristem Ltd.

    lead INDUSTRY

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03797040 on ClinicalTrials.gov