Status:
UNKNOWN
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)
Lead Sponsor:
Pluristem Ltd.
Conditions:
Ionizing Radiation Exposure
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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:Pos...
Detailed Description
This will be a Phase I, open-label safety study; each subject will receive two administrations of PLX-R18, 4 days apart. Each administration of PLX-R18 will contain 4 million cells/kg (up to a maximal...
Eligibility Criteria
Inclusion
- Subject was exposed or suspected to have been exposed to ionizing radiation of
- ≥1Gy and is at risk of developing HS-ARS, as assessed by the treating physician, based on REMM guidelines (see APPENDIX 1).
- PLX-R18 treatment can be initiated within 4 days of exposure.
- Aged ≥18 years.
- Has provided informed consent. -
Exclusion
- 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.
- \-
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03797040
Start Date
January 1 2021
End Date
December 1 2021
Last Update
July 28 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.