Perflubron Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A completed Phase 1 pilot study evaluated the safety of partial liquid ventilation using perflubron for up to 10 days in neonates with severe bronchopulmonary dysplasia. Sponsored by academic and charitable organizations, specifically the Children's Hospital of Philadelphia and the Auto Dealers Caring for Kids Foundation, clinical evaluation of perflubron remains focused on early-phase safety assessments for pediatric pulmonary conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03041740	Completed	Bronchopulmonary Dysplasia	Children''s Hospital of Philadelphia\|Auto Dealers Caring for Kids Foundation	2017-06-27	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Perflubron product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Perflubron functions as an inert perfluorocarbon agent that suppresses pro-inflammatory cytokine production in human alveolar macrophages while blunting oxidative damage to biological tissues. By limiting macrophage-mediated inflammation and oxidative injury within pulmonary tissue, this compound supports alveolar structure and reduces lung injury in respiratory conditions such as bronchopulmonary dysplasia.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).