Indigo Clinical Trials

Size	Price	Qty
25mg	USD 157

Clinical Trials

Several clinical trials evaluate Indigo applications in diagnostic imaging and interventional procedures for conditions such as lower limb ischemia, acute lower limb ischemia, Lynch syndrome, inflammatory bowel diseases, and colonic polyps. These investigational efforts span Phase 1 studies and trials designated as Not Applicable, supported by sponsors including the Mayo Clinic, Assistance Publique - Hôpitaux de Paris, and St. Franziskus Hospital. Recruitment statuses across these records encompass completed trials as well as those listed with an unknown status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03295539	Unknown status	Lower Limb Ischemia	Lancashire Care NHS Foundation Trust\|St. Franziskus Hospital	2017-11-01	Not Applicable
NCT03386370	Unknown status	Acute Ischemia of Lower Limb	Azienda Ospedaliera Universitaria Senese	2017-09-01	Not Applicable
NCT02570516	Completed	Lynch Syndrome	Assistance Publique - Hôpitaux de Paris\|ARC Foundation for Cancer Research	2015-11	Not Applicable
NCT01914445	Unknown status	Inflammatory Bowel Diseases	Hillel Yaffe Medical Center	2013-08	Not Applicable
NCT01901510	Completed	Colonic Polyps	Mayo Clinic	2013-05	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Indigo acts as an endoscopic contrast stain that selectively accumulates within mucosal crevices without direct cellular absorption, thereby enhancing surface topography and structural detail. This contrast-driven visual delineation permits the improved endoscopic detection and evaluation of gastrointestinal pathologies, directly supporting diagnostic screening for conditions such as colonic polyps, inflammatory bowel disease, and Lynch syndrome.

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>).