Thrombosomes for Expanded Access Use

NCT ID: NCT04619108

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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.

Conditions

Bleeding

Interventions

Thrombosomes®

Intervention Type: BIOLOGICAL

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cellphire Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Thrombosomes Expanded Access

Identifier Type: -

Identifier Source: org_study_id