Clinical Trials

A clinical trial sponsored by Saint Luke's Health System, a regional healthcare provider, focuses on aortic valve disease by quantifying embolic debris collected during valve-in-valve transcatheter aortic valve replacement procedures involving TCEP. The trial has no assigned trial phase, categorized as not applicable, and its recruitment status is currently recorded as unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05093764 UNKNOWN
Aortic Valve Disease
Saint Luke's Health System
 2022-03-02

(data from https://clinicaltrials.gov, updated on 2024-06-14)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a non-thiol reducing agent, TCEP hydrochloride selectively cleaves disulfide bonds within target proteins, thereby stimulating NF-κB DNA-binding capacity and modulating downstream redox-dependent signaling pathways. This targeted reduction of disulfide bridges alters cellular redox homeostasis, contributing to biochemical responses relevant to clinical research in aortic valve disease.

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.