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 | Unknown Phase 1 FDA Drug

• 1 other identifier: PLX-R18-ARS-01
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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: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

Outcome Measures

Primary Outcomes (1)

• Any Adverse Reaction

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

Secondary Outcomes (4)

• Recovered with no sequelae

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

• Recovered with sequelae

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

• Ongoing AE

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

• Overall survival

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

Study Arms (1)

4 million PLX-R18 cells/kg-up to a maximal dose of 400 million

EXPERIMENTAL

Biological: Cell therapy

Interventions

Cell therapy BIOLOGICAL

PLX-R18: Allogeneic ex vivo expanded placental stromal cells

Also known as: PLX-R18

4 million PLX-R18 cells/kg-up to a maximal dose of 400 million

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pluristem Ltd.: lead

MeSH Terms

Interventions

Cell- and Tissue-Based Therapy

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: January 8, 2019
• Study Start: January 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share