Bleeding
Conditions
Brief summary
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.
Interventions
BIOLOGICALThrombosomes®
Sponsors
Cellphire Therapeutics, Inc.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Outcome results
None listed