UnknownPhase 1

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)

27 participantsStarted 2021-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subject was exposed or suspected to have been exposed to ionizing radiation of
✓. PLX-R18 treatment can be initiated within 4 days of exposure.
✓. Aged ≥18 years.
✓. Has provided informed consent. -

Exclusion criteria

✕. Known active malignancy or history of malignancy within 3 years prior to screening except for successfully resected skin basal cell carcinoma or skin squamous cell carcinoma not located at the injection sites.
✕. Known active uncontrolled infection (e.g. viral, fungal, and/or bacterial)
✕. Known active infection with Hepatitis A, B, or C.
✕. Pregnancy.
✕. Known hypersensitivity to: Allogeneic stromal cells, dimethyl sulfoxid (DMSO), human serum albumin, or bovine products.
✕. In the opinion of the Investigator the subject is at high risk of developing severe allergic/hypersensitivity reactions and a resuscitation kit including epinephrine is not at hand.
✕. In the opinion of the treating physician, the subject is unsuitable for participating in the study.

What they're measuring

Any Adverse Reaction

Timeframe: From Week 52 to Week 260 patients will be followed-up for overall survival once a year (every 52 weeks±2 after visit 14)

Trial details

NCT IDNCT03797040

SponsorPluristem Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12

View on ClinicalTrials.gov More Ionizing Radiation Exposure trials