Thrombosomes for Expanded Access Use

Bleeding Clinical Trial

Official title:

Thrombosomes for Expanded Access Use

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT04619108
• Other study ID #: Thrombosomes Expanded Access
• Status: No longer available

Study information

• Verified date: March 2024
• Source: Cellphire Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bleeding

Intervention

Biological:
• Thrombosomes®

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cellphire Therapeutics, Inc.