drugset

drugset / Trial / NCT03394755

Thrombosomes® in Bleeding Thrombocytopenic Patients

NCT03394755 ↗

Phase 1 Completed 24 enrolled Cellphire Therapeutics, Inc. Department of Health and Human Services · collab

Non-randomizedSequentialOpen-labelTreatment

Summary

The study evaluates the safety and potential early signals of efficacy of allogeneic Thrombosomes in bleeding thrombocytopenic patients

Timeline

Start: 2018-03-19
Primary completion: 2019-08-01
Completion: 2019-09-25

Publications

Background Ohanian M, Cancelas JA, Davenport R, Pullarkat V, Hervig T, Broome C, Marek K, Kelly M, Gul Z, Rugg N, Nestheide S, Kinne B, Szczepiorkowski Z, Kantarjian H, Pehta J, Biehl R, Yu A, Aung F, Antebi B, Fitzpatrick GM. Freeze-dried platelets are a promising alternative in bleeding thrombocytopenic patients with hematological malignancies. Am J Hematol. 2022 Mar 1;97(3):256-266. doi: 10.1002/ajh.26403. Epub 2021 Dec 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Thrombosomes	Other / unclassified	9.45e+07 cells/kg	—
Subject	Thrombosomes	Other / unclassified	1.89e+08 cells/kg	—
Subject	Thrombosomes	Other / unclassified	3.78e+08 cells/kg	—

Indications