Oil Red O Clinical Trials

Size	Price	Qty
100mg	USD 97

Clinical Trials

Multiple clinical trials sponsored by the Centre Hospitalier Universitaire de Besançon are currently registered to investigate airway management during panendoscopy under general anesthesia for ear, nose, and throat (ENT) tumors. These unphased studies, which are not yet recruiting, evaluate techniques such as high-flow nasal oxygen therapy and varied ventilation strategies. Ultimately, the trials aim to optimize perioperative oxygenation parameters and mitigate intraoperative hypoxaemia in patients undergoing surgical procedures for ENT tumors.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05593718	Not yet recruiting	ENT Tumor	Centre Hospitalier Universitaire de Besancon	2024-10-20	--
NCT05601570	Not yet recruiting	ENT Tumor	Centre Hospitalier Universitaire de Besancon	2024-04-10	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Oil Red O preferentially partitions into neutral lipids and cholesterol esters while interacting with double-stranded DNA to generate a strong fluorescence emission centered at 600 nm. This target-specific fluorescent staining enables the histological visualization of intracellular lipid accumulation, facilitating pathological characterization and tissue evaluation in diagnostic contexts such as ENT tumors.

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>).