JC-1 Clinical Trials

Size	Price	Qty
5mg	USD 427

Clinical Trials

A completed clinical trial sponsored by the Sheffield Teaching Hospitals NHS Foundation Trust investigated the biological context of JC-1 in chronic obstructive pulmonary disease (COPD). Conducted as an observational research protocol with no assigned trial phase, the study evaluated the mechanisms, clinical impact, and potential therapeutic strategies surrounding bacterial colonization in affected patients. Overall, this research underscores the application of mitochondrial assessment in evaluating underlying cellular pathology in COPD.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03161561	Completed	COPD	Sheffield Teaching Hospitals NHS Foundation Trust	2011-11-16	Not Applicable

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

Check the JC-1 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a lipophilic carbocyanine dye, JC-1 selectively permeates cellular membranes and accumulates within intact mitochondria driven by the transmembrane potential, undergoing a concentration-dependent shift from green-fluorescent monomers to red-fluorescent J-aggregates upon hyperpolarization. This potential-dependent aggregation allows precise monitoring of mitochondrial depolarization and apoptotic pathway activation, providing essential bioenergetic metrics relevant to investigating cellular stress and airway inflammation in chronic obstructive pulmonary 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>).