# A novel agent to manage thrombocytopenic patients with platelet transfusion refractoriness

> **NIH NIH R43** · FIBROPLATE, INC. · 2021 · $253,688

## Abstract

PROJECT SUMMARY
Platelet Transfusion Refractoriness (PTR) or the failure to achieve the desired level of blood platelets after
platelet transfusion, hampers the management of bleeding episodes in thrombocytopenic patients. PTR
condition is associated with a high risk of severe bleeding complications and reduced survival rate, longer
hospital stays and higher hospital costs. Existing management strategies are based on the transfusion of
leukodepleted products, HLA-matched platelets, or cross-matched platelets which are obtained after lengthy
and expensive procedures. Alternatives consisting of thrombopoietin mimetics, or recombinant factor XIII
have not shown the ability to reduce mortality. Fibroplate is proposing a new approach to manage bleeding
in thrombocytopenic patients who develop PTR, based on the intravenous injection of Fibrinoplate-S (FPS),
a ready-to-use suspension of fibrinogen-coated albumin nanospheres. FPS significantly reduces the bleeding
time and improves overall survival rate associated with radiation-induced thrombocytopenia in preclinical
rodent models through the formation of co-aggregates with the residual activated platelets at wound sites on
the endothelium of the blood vessel. Various preclinical studies demonstrated that FPS is safe and does not
induce intravascular coagulation. Remarkably, FPS is not sequestered in the spleen, and FPS specific
antibodies have not been detected after its administration in humans. These characteristics, together with its
hemostatic capacity support the use of FPS in the management of thrombocytopenic patients with immune
and non-immune PTR. However, their efficacy and safety need validation in a thrombocytopenic preclinical
model under PTR conditions. This NIH SBIR Phase I aims at investigating i) the efficacy of FPS in reducing
bleeding parameters in an established (double) model of thrombocytopenia and PTR (TPTR) preclinically in
rabbits and ii) the safety of the proposed approach. By offering effective treatment, Fibroplate is expected to
reduce bleeding complications and improve and promote survival in thrombocytopenic patients with PTR.

## Key facts

- **NIH application ID:** 10250676
- **Project number:** 1R43HL156324-01A1
- **Recipient organization:** FIBROPLATE, INC.
- **Principal Investigator:** Richard Yen
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $253,688
- **Award type:** 1
- **Project period:** 2021-06-01 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10250676

## Citation

> US National Institutes of Health, RePORTER application 10250676, A novel agent to manage thrombocytopenic patients with platelet transfusion refractoriness (1R43HL156324-01A1). Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/grant/nih/10250676. Licensed CC0.

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