Thrombosomes for Expanded Access Use

NCT04619108 | Unknown

• 1 other identifier: Thrombosomes Expanded Access
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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® BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cellphire Therapeutics, Inc.: lead

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 6, 2020
• Last Updated: March 21, 2024

Record last verified: 2024-03