Stigmasterol Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Multiple clinical trials have evaluated stigmasterol-associated formulations in pediatric populations, specifically investigating essential fatty acid deficiency and child malnutrition. Sponsored by healthcare companies such as Baxter Healthcare Corporation and Fresenius Kabi, these Phase IV studies included a completed trial evaluating essential fatty acid deficiency risks and a terminated trial regarding lipid emulsion safety in malnourished children.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04555044	Completed	Essential Fatty Acid Deficiency (EFAD)	Baxter Healthcare Corporation	2021-01-22	Phase 4
NCT03563222	Terminated	Malnutrition Child	Fresenius Kabi	2019-12-18	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a phytosterol structurally analogous to cholesterol, stigmasterol incorporates into cellular lipid bilayers and modulates membrane-bound enzymes and nuclear receptors involved in lipid transport and steroidogenesis. This interaction downregulates pro-inflammatory signaling cascades and stabilizes membrane fluidity, thereby preserving cellular structural integrity and reducing inflammatory signaling. Consequently, these biochemical actions support lipid homeostasis and nutritional maintenance, offering therapeutic relevance in pediatric conditions such as child malnutrition and essential fatty acid deficiency.

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>).