NCT03394755 is a Phase 1 clinical trial of Thrombosomes in Thrombocytopenia, sponsored by Cellphire Therapeutics, Inc..

Who is sponsoring NCT03394755?

NCT03394755 is sponsored by Cellphire Therapeutics, Inc..

What drugs are being tested in NCT03394755?

Interventions in NCT03394755: Thrombosomes.

What condition does NCT03394755 study?

NCT03394755 studies Thrombocytopenia, Hematologic Diseases, Bone Marrow Aplasia.

Is NCT03394755 still recruiting?

NCT03394755 is currently completed. Last updated 14 April 2023.

Are results published for NCT03394755?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-04-14 · How we verify

NCT03394755

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Thrombosomes® in Bleeding Thrombocytopenic Patients

Completed Phase 1 Results posted Last updated 14 April 2023

What this trial tests

Phase 1 trial testing Thrombosomes in Thrombocytopenia in 24 participants. Completed in 25 September 2019.

Timeline

19 March 2018

Primary endpoint
1 August 2019

25 September 2019

Quick facts

Lead sponsor	Cellphire Therapeutics, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	19 March 2018
Primary completion	1 August 2019
Estimated completion	25 September 2019
Sites	7 locations across United States, Norway

Drugs / interventions tested

Thrombosomes

Conditions studied

Thrombocytopenia — all drugs for Thrombocytopenia →
Hematologic Diseases — all drugs for Hematologic Diseases →
Bone Marrow Aplasia — all drugs for Bone Marrow Aplasia →

Sponsor

Cellphire Therapeutics, Inc. — full company profile →

Who can join

Adults 18 to 74, any sex, with Thrombocytopenia or Hematologic Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients With Treatment-Emergent Adverse Events (TEAE) Primary · 30 days

Overall frequency of (and number and percentage of patients who experience) TEAEs including serious adverse drug reactions and treatment-related events specifically defining the study's suspension and stopping rules (i.e., thromboembolic events, acute lung injury, anaphylaxis, and death).

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	7
Thrombosomes 189 Million Particles/kg Body Weight	6
Thrombosomes 378 Million Particles/kg Body Weight	5

Number of Patients With Treatment-Emergent Serious Adverse Events (TESAE) Primary · 30 days

Overall frequency of (and number and percentage of patients who experience) TESAEs including serious adverse drug reactions and treatment-related events specifically defining the study's suspension and stopping rules (i.e., thromboembolic events, acute lung injury, anaphylaxis, and death).

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	1
Thrombosomes 189 Million Particles/kg Body Weight	5
Thrombosomes 378 Million Particles/kg Body Weight	4

Number of WHO Bleeding Sites With Status Change From Baseline Secondary · 1, 6, 24 hours, and Day 6 post infusion

Grade-level change in WHO bleeding assessment score at most severe bleeding site from baseline; WHO bleeding assessment score ranges from 1 to 4, with higher numbers indicating worse bleeding.

1 hour post infusion

Group	Value	95% CI
Worsened	0
No Change	24
Improved	3

6hrs post infusion

Group	Value	95% CI
Worsened	0
No Change	21
Improved	6

24 hours post infusion

Group	Value	95% CI
Worsened	0
No Change	17
Improved	10

Day 6

Group	Value	95% CI
Worsened	0
No Change	10
Improved	17

Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site Secondary · Baseline, 1, 6, 24 hours, and Day 6 post infusion

Patients WHO score at primary bleeding site. WHO bleeding assessment score ranges from 1 to 4, with higher numbers indicating worse bleeding. The maximum WHO bleeding assessment score for patients on study was 2.

Baseline

Group	Value	95% CI
Grade 0	0
Grade 1	7
Grade 2	15

1 hour post infusion

Group	Value	95% CI
Grade 0	1
Grade 1	7
Grade 2	14

6 hours post infusion

Group	Value	95% CI
Grade 0	3
Grade 1	7
Grade 2	12

24 hours post infusion

Group	Value	95% CI
Grade 0	4
Grade 1	6
Grade 2	12

Day 6

Group	Value	95% CI
Grade 0	8
Grade 1	6
Grade 2	8

Number of Patients With a Shift From Baseline in Hemoglobin Secondary · 1, 6, 24 hours, Day 3, 4, 5, and 6 post infusion

Shift from baseline clinical status of hemoglobin measure at different timepoints post infusion

1 hour post infusion

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0

6 hours post infusion

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0

24 hours post infusion

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0

Day 3

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0

Day 4

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0

Day 5

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0

Day 6

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0

Number of Patients With a Shift From Baseline in Hematocrit Secondary · 1, 6, 24 hours, Day 3, 4, 5, and 6 post infusion

Shift from baseline clinical status of hematocrit measure at different timepoints post infusion

1 hour post infusion

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0

6 hours post infusion

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0

24 hours post infusion

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0

Day 3

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0

Day 4

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0

Day 5

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0

Day 6

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0

Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion Secondary · 24 hours post infusion

Shift from baseline clinical status of coagulation measure at 24 hours post infusion for each cohort

Prothrombin Time (PT)

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	6
Thrombosomes 189 Million Particles/kg Body Weight	5
Thrombosomes 378 Million Particles/kg Body Weight	5
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	1
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	1

International Normalized Ratio (INR)

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	7
Thrombosomes 189 Million Particles/kg Body Weight	7
Thrombosomes 378 Million Particles/kg Body Weight	6
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	1
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	1

Activated Partial Thromboplastin Time (aPTT)

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	2
Thrombosomes 189 Million Particles/kg Body Weight	6
Thrombosomes 378 Million Particles/kg Body Weight	4
Thrombosomes 94.5 Million Particles/kg Body Weight	1
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	1
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	1

D-dimer

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	1
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	1
Thrombosomes 378 Million Particles/kg Body Weight	0

Fibrinogen

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	2
Thrombosomes 189 Million Particles/kg Body Weight	5
Thrombosomes 378 Million Particles/kg Body Weight	3
Thrombosomes 94.5 Million Particles/kg Body Weight	1
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	1

Thrombin Antithrombin (TAT)

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	1
Thrombosomes 189 Million Particles/kg Body Weight	2
Thrombosomes 378 Million Particles/kg Body Weight	2
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	1
Thrombosomes 378 Million Particles/kg Body Weight	1
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	1
Thrombosomes 189 Million Particles/kg Body Weight	1
Thrombosomes 378 Million Particles/kg Body Weight	0

Prothrombin Fragment (PF) 1+2

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	1
Thrombosomes 189 Million Particles/kg Body Weight	2
Thrombosomes 378 Million Particles/kg Body Weight	1
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	1
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	3

Thrombin Generation Assay (TGA) (Lag Time)

Group	Value	95% CI
Thrombosomes 94.5 Million Particles/kg Body Weight	7
Thrombosomes 189 Million Particles/kg Body Weight	7
Thrombosomes 378 Million Particles/kg Body Weight	7
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0
Thrombosomes 94.5 Million Particles/kg Body Weight	0
Thrombosomes 189 Million Particles/kg Body Weight	0
Thrombosomes 378 Million Particles/kg Body Weight	0

Median Platelet Counts Secondary · Screening, Baseline, 1, 6, 24 hours, Day 3, 4, 5, and 6 post infusion

Median Platelet Counts Per Time Point

Screening

Group	Value	95% CI
Platelets	16	8 – 48

Baseline

Group	Value	95% CI
Platelets	18.5	2 – 51

1 hour post infusion

Group	Value	95% CI
Platelets	13.5	2 – 46

6 hrs post infusion

Group	Value	95% CI
Platelets	14	1 – 46

24 hrs post infusion

Group	Value	95% CI
Platelets	20.5	2 – 78

Day 3

Group	Value	95% CI
Platelets	22.5	3 – 83

Day 4

Group	Value	95% CI
Platelets	18.5	3 – 106

Day 5

Group	Value	95% CI
Platelets	20	6 – 146

Adverse events — posted to ClinicalTrials.gov

Time frame: All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Thrombosomes 94.5 Million Particles/kg Body Weight

Serious: 1/8 (13%)

Deaths: 0/8

Thrombosomes 189 Million Particles/kg Body Weight

Serious: 5/8 (63%)

Deaths: 3/8

Thrombosomes 378 Million Particles/kg Body Weight

Serious: 4/8 (50%)

Deaths: 3/8

Serious adverse events (14 terms)

Reaction	System	Thrombosomes 94.5 Million …	Thrombosomes 189 Million P…	Thrombosomes 378 Million P…
Sepsis	Infections and infestations	—	—	—
Bacteremia	Infections and infestations	—	—	—
Cholecystitis infective	Infections and infestations	—	—	—
Encephalitis viral	Infections and infestations	—	—	—
Pathogen resistance	Infections and infestations	—	—	—
Septic shock	Infections and infestations	—	—	—
Fatigue	General disorders	—	—	—
Multiple organ dysfunction syndrome	General disorders	—	—	—
Necrosis	General disorders	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Pituitary haemorrhage	Endocrine disorders	—	—	—
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—
Acute graft versus host disease	Immune system disorders	—	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	Thrombosomes 94.5 Million …	Thrombosomes 189 Million P…	Thrombosomes 378 Million P…
Diarrhoea	Gastrointestinal disorders	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—
Pyrexia	General disorders	—	—	—
Fatigue	General disorders	—	—	—
Sepsis	Infections and infestations	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—
Hypertension	Vascular disorders	—	—	—

Most-reported serious reactions: Sepsis, Bacteremia, Cholecystitis infective, Encephalitis viral, Pathogen resistance, Septic shock, Fatigue, Multiple organ dysfunction syndrome.

Data from ClinicalTrials.gov NCT03394755 adverse events section.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

The effect of platelet storage temperature on haemostatic, immune, and endothelial function: potential for personalised medicine.
Shea SM, Thomas KA, Spinella PC. · · 2019 · cited 24× · PMID 31385802 · DOI 10.2450/2019.0095-19
Lyophilized platelets inhibit platelet aggregation with simultaneous paradoxical promotion of platelet adhesion.
Schnoor B, Papa AL. · · 2022 · cited 5× · PMID 36061448 · DOI 10.3389/fbioe.2022.941817

Verify or expand the search:

Other trials of Thrombosomes

Trials testing the same drug.

NCT04631211 — Thrombosomes® in Bleeding Thrombocytopenic Patients Study · Phase 2 · terminated

Other recruiting trials for Thrombocytopenia

Currently open trials in the same condition.

NCT07441720 — Safety and Efficacy of Umbilical Cord Blood Therapy for Cancer Therapy-Induced Thrombocytopenia (CTIT) · Phase 2 · recruiting
NCT07442513 — Comparison of Etamsylate Versus Placebo to Prevent Bleeding in HSCT · Phase 3 · recruiting
NCT07257809 — Herombopag Treated T-DM1 Induced Platelet Reduction · Phase 2 · recruiting
NCT06676904 — Neonatal Platelet Transfusion Threshold Trial · NA · recruiting
NCT06886516 — Apixaban in Thrombocytopenia · EARLY_PHASE1 · recruiting

Other Cellphire Therapeutics, Inc. trials

Trials by the same sponsor.

NCT04709705 — DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS) · Phase 2, PHASE3 · completed
NCT04631211 — Thrombosomes® in Bleeding Thrombocytopenic Patients Study · Phase 2 · terminated
NCT04619108 — Thrombosomes for Expanded Access Use · no longer available

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03394755 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cellphire Therapeutics, Inc.
Last refreshed: 14 April 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03394755.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03394755

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (14 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Thrombosomes

Other recruiting trials for Thrombocytopenia

Other Cellphire Therapeutics, Inc. trials

Verify against primary sources