Clinical Trials

Multiple clinical trials evaluate Fluorescein-5-isothiocyanate (FITC) across diverse pathological conditions, including osteosarcoma, gene polymorphism-associated lung inflammation, and ulcerative colitis. This research landscape encompasses an active early-phase study investigating FITC-directed chimeric antigen receptor T-cell therapies, a completed observational study assessing macrophage responses, and a terminated trial focused on efficacy biomarkers. These initiatives are supported by academic, governmental, and industrial sponsors, including Seattle Children's Hospital, Nantes University Hospital, the National Institute of Environmental Health Sciences, Umoja BioPharma, and Takeda.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05312411 Recruiting
Osteosarcoma
Seattle Children''s Hospital|Umoja BioPharma Inc.
 2022-05-20 Phase 1
NCT02743468 Completed
Polymorphism|Lung Inflammation
National Institute of Environmental Health Sciences (NIEHS)|National Institutes of Health Clinical Center (CC)
 2019-01-08 --
NCT02878083 Terminated
ULCERATIVE COLITIS
Nantes University Hospital|Takeda|Mauna Kea Technologies|Institut National de la Santé Et de la Recherche Médicale France
 2017-01-11 Not Applicable

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

Check the Fluorescein-5-isothiocyanate (FITC) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fluorescein-5-isothiocyanate covalently binds to primary amine residues on proteins and cellular targets to form stable thiourea conjugates, effectively tagging specific cell populations for fluorescence-based detection and receptor recognition. This molecular labeling enables precise tracking and targeted immune cell engagement, providing the basis for diagnostic imaging in inflammatory conditions like ulcerative colitis and antigen-directed cell therapies against solid tumors such as osteosarcoma.

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.