Clinical Trials

Several clinical trials have evaluated PMSF-associated parameters and outcomes in surgical and critical care settings, focusing on conditions such as cardiac surgery, valve replacement, coronary artery bypass, peri-operative fluid management, and sepsis. Sponsored predominantly by academic and hospital centers—including University Hospital Strasbourg and St George's University of London—these studies utilize non-interventional or not applicable phase classifications, with recruitment statuses ranging from completed to unknown. Overall, this body of research highlights hemodynamic monitoring and fluid responsiveness in critical care and cardiovascular surgery.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04062786 Unknown status
Scheduled Heart Surgery|Valve Replacement|Coronary Artery Bypass
University Hospital Strasbourg France
2019-02-21 --
NCT03300323 Unknown status
Peri-operative Fluid Management
St George''s Healthcare NHS Trust
2017-10 Not Applicable
NCT02447042 COMPLETED
Sepsis
St George's, University of London
2014-11
NCT02569008 COMPLETED
Post Cardiac Surgery
St George's, University of London
2014-01
NCT02569008 Completed
Post Cardiac Surgery
St George''s University of London
2014-01 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

PMSF covalently binds to and irreversibly inhibits active-site serine and cysteine proteases, thereby blocking downstream enzymatic cleavage, acetylcholinesterase activity, and anandamide degradation. This cellular inhibition stabilizes extracellular glutamate levels and modulates lipid signaling, offering potential therapeutic utility in mitigating ischemic damage and supporting hemodynamic stabilization in clinical conditions such as sepsis and post-cardiac surgery care.

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>).

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