Thrombosomes for Expanded Access Use

Cellphire Therapeutics

Status

Conditions: Bleeding

Treatments: Biological: Thrombosomes®

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT04619108

Thrombosomes Expanded Access

Details and patient eligibility

About

Expanded use of Thrombosomes where a clinical trial with Thrombosomes is not an option, Cellphire may elect to provide the Sponsor/Investigator (S/I) expanded access to its investigational product, Thrombosomes.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Subject has presented with WHO Grade 2 or higher bleeding which requires treatment with platelet therapy and there is limited availability of platelets or no other approved clinical alternative.

2. Evidence from the facility blood bank/Medical Director that there are no approved platelet products available for transfusion, or the patient is refractory to platelet transfusion.

   Exclusion Criteria:

3. Clinical circumstances of a history of thrombosis, thromboembolism, or vascular occlusion/ischemia in the prior six months such as defined by a past history of current diagnosis of one or more of the following:

   • arterial or venous thromboembolic disease including acute coronary syndrome
   • peripheral vascular disease
   • arterial or venous thrombosis (except when a prior history of central line thrombosis has resolved)
   • myocardial infarction (MI)
   • stent placement
   • valve replacement and/or repair
   • sinusoidal obstruction syndrome (veno-occlusive disease)