25-Hydroxycholesterol Clinical Trials

Size	Price	Qty
5mg	USD 97
25mg	USD 290

Clinical Trials

A clinical trial evaluated 25-hydroxycholesterol as a therapeutic metabolic intervention in patients with hereditary spastic paraplegia, specifically subtype SPG5. Sponsored by the Institut National de la Santé Et de la Recherche Médicale France, this completed Phase II study focused on modulating metabolic pathways to treat specific hereditary neurodegenerative disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02314208	Completed	Spastic Paraplegia Hereditary	Institut National de la Santé Et de la Recherche Médicale France	2015-01	Phase 2

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

Check the 25-Hydroxycholesterol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

25-Hydroxycholesterol acts as a side-chain oxysterol that selectively suppresses IgA production in B cells with an EC50 of approximately 65 nM, thereby downregulating humoral immune responses and altering cellular lipid homeostasis. Disruption of these metabolic and immunomodulatory pathways modulates downstream cellular signaling, providing mechanistic relevance for investigating therapeutic interventions in hereditary spastic paraplegia.

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>).