Autopsy report · NCT03857841

A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD

“The study was discontinued due to a business decision; no safety concerns were noted.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 8 months before it started.
• Ran for about 1 year 7 months before it stopped.
• 3 participants enrolled.
• Results were posted on the registry 5 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 1

Sponsor

United Therapeutics

Sponsor type

Industry

Conditions

Bronchopulmonary Dysplasia

Interventions

UNEX-42; Phosphate-buffered saline

Participants

3

Sites

6

Countries

United States

Trials that died the same way

• An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma
  “The termination was due to business reasons. No safety or efficacy concerns contributed to the termination of the study” (79% match in meaning)
• Tislelizumab Monotherapy Versus Salvage Chemotherapy for Relapsed/Refractory Classical Hodgkin Lymphoma
  “Study has voluntarily discontinued due to a change in the company-level development strategy and is not because of any safety concern.” (78% match in meaning)
• A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome
  “The study was terminated by Sponsor and the decision was not due to any safety or efficacy reasons.” (77% match in meaning)
• A Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients
  “The study has been early terminated due to business reasons. This decision is not related to any safety, efficacy, or regulatory concerns.” (76% match in meaning)
• GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
  “The study was terminated due to insufficient efficacy to support moving into Part 2 of the study; there were no safety concerns that contributed to this decision.” (76% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.