Trypan Blue Clinical Trials

Size	Price	Qty
500mg	USD 147

Clinical Trials

Several clinical trials are evaluating the surgical and diagnostic applications of Trypan Blue for conditions including cataract, osteoarthritis, and corneal transplant failure with corneal endothelial cell loss. Sponsored by academic institutions, healthcare trusts, and specialized research foundations, these studies largely encompass unassigned or not applicable trial phases. Recruitment status across the portfolio varies, with active enrollment underway for studies on corneal cell viability and juvenile musculoskeletal tissues, alongside an unknown status for research evaluating phacoemulsification incision outcomes.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05847387	Recruiting	Corneal Transplant Failure\|Corneal Endothelial Cell Loss	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia	2023-12-01	--
NCT06167928	Recruiting	Osteoarthritis	Keele University\|Alder Hey Children''s NHS Foundation Trust\|Birmingham Women''s and Children''s NHS Foundation Trust\|Norfolk and Norwich University Hospitals NHS Foundation Trust\|Royal National Orthopaedic Hospital NHS Trust\|Scottish National Blood Transfusion Service\|NHS Blood and Transplant\|University of Birmingham\|Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust\|The Royal Orthopaedic Hospital NHS Trust	2018-10-08	--
NCT01385878	Unknown status	Cataract	Iladevi Cataract and IOL Research Center	2011-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Trypan blue is a cell-impermeable azo dye that selectively traverses compromised cell membranes of non-viable cells and binds to intracellular proteins, staining dead cells blue while remaining excluded from intact living cells. This selective dye exclusion mechanism enables direct visualization and quantification of cell membrane integrity under light microscopy, which is directly relevant for assessing corneal endothelial cell viability prior to keratoplasty, evaluating tissue health in osteoarthritis models, and assisting visualization during cataract surgery.

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>).