Clinical Trials

A clinical trial sponsored by Lille Catholic University evaluated the analytical application of Safranin O in assessing femur head necrosis. This completed observational study was designated as Phase Not Applicable, focusing on diagnostic tissue characterization and magnetic resonance imaging correlations rather than therapeutic intervention. Consequently, clinical research on Safranin O remains an academic effort centered on elucidating compositional and structural modifications in aseptic osteonecrosis etiopathogenesis.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02733900 Completed
Femur Head Necrosis
Lille Catholic University
 2016-02 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Safranin O is a cationic phenazinium dye that selectively binds via electrostatic interactions to polyanionic glycosaminoglycans within the extracellular matrix, thereby enabling localized optical detection and histochemical quantification of proteoglycan distribution. By revealing changes in matrix composition and proteoglycan density, this targeted staining mechanism facilitates the assessment of cartilage degradation and structural tissue remodeling in pathologies such as femur head necrosis.

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>).

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Note: Technical data last updated: Sep 1, 2026.