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Platelet Transfusion

Thrombosomes for Low Platelet Count

Phase 2

Waitlist Available

Led By Terry Gernsheimer, MD

Research Sponsored by Cellphire, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24, 48, 72 hours, day 4, day 5, day 6 and day 7 post first infusion

Awards & highlights

Study Summary

This trialwill compare the safety and effect of a new treatment (Thrombosomes) to standard care (LSP) in people with bleeding disorders.

Eligible Conditions

Low Platelet Count
Myeloproliferative Disorder
Blood Cancers
Bone Marrow Aplasia
Platelet Transfusion
Myelodysplastic Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24, 48, 72 hours, day 4, day 5, day 6 and day 7 post first infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24, 48, 72 hours, day 4, day 5, day 6 and day 7 post first infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24, 48, 72 hours, day 4, day 5, day 6 and day 7 post first infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Efficacy Endpoint

Secondary outcome measures

Secondary Efficacy Endpoint assessed by 30 day mortality

Hemorrhage

+5 more

Other outcome measures

Safety Endpoint

Side effects data

From 2019 Phase 1 trial • 24 Patients • NCT03394755

38%

Febrile neutropenia

38%

Diarrhoea

25%

Pyrexia

13%

Necrosis

13%

Hypophosphataemia

13%

Pathogen resistance

13%

Anaemia

13%

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Thrombosomes 94.5 Million Particles/kg Body Weight

Thrombosomes 189 Million Particles/kg Body Weight

Thrombosomes 378 Million Particles/kg Body Weight

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Thrombosomes Medium DoseExperimental Treatment1 Intervention

Group II: Thrombosomes Low DoseExperimental Treatment1 Intervention

Group III: Thrombosomes High DoseExperimental Treatment1 Intervention

Group IV: Liquid Stored Platelets (Control)Active Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Thrombosomes

2018

Completed Phase 1

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cellphire, Inc.Lead Sponsor

4 Previous Clinical Trials

239 Total Patients Enrolled

Cellphire Therapeutics, Inc.Lead Sponsor

5 Previous Clinical Trials

279 Total Patients Enrolled

Department of Health and Human ServicesFED

226 Previous Clinical Trials

928,928 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being taken in for this experiment?

"Unfortunately, this specific study is no longer recruiting patients. The original posting was on March 5th, 2021 but the page was updated as recently as October 31st, 2022. It's worth noting that there are 887 other clinical trials currently enrolling participants."

Answered by AI

Are a lot of these tests being done in different hospitals around the state?

"This clinical trial is being conducted at City of Hope (Duarte, California), MD Anderson Cancer Center (Houston, Texas), Vanderbilt University Medical Center (Nashville, Tennessee) as well as 4 other locations."

Answered by AI

Has the FDA cleared Thrombosomes for public use?

"At Power, we gave Thrombosomes a score of 2 for safety. This is because, although there is some data supporting safety, none of it suggests that the product is effective."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Thrombosomes® in Bleeding Thrombocytopenic Patients Study

2021. "Thrombosomes® in Bleeding Thrombocytopenic Patients Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04631211.