CFSE (CFDA-SE) Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 397

Clinical Trials

Several completed clinical trials evaluate immune responses and therapeutic approaches for HIV infections, encompassing early Phase 1 interventional and observational protocols. Supported by key sponsors including the National Institute of Allergy and Infectious Diseases, Novartis Vaccines and Diagnostics, and the Istituto Superiore di Sanità, these studies assess candidate vaccines, immunotherapeutic agents, antibody pharmacokinetics, safety, and immunogenicity in HIV-infected patient cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02028403	Completed	HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)	2014-06	Phase 1
NCT01376726	Completed	HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)\|Novartis Vaccines and Diagnostics Inc	2011-07	Phase 1
NCT01029548	Completed	HIV Infections	Barbara Ensoli MD\|Istituto Superiore di Sanità	2008-04	--
NCT01024556	Completed	HIV Infection	Barbara Ensoli MD\|Istituto Superiore di Sanità	2008-03	--

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

Check the CFSE (CFDA-SE) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a cell-permeable dye, carboxyfluorescein succinimidyl ester diffuses into the cytoplasm and covalently couples via its succinimidyl ester group to intracellular lysine residues and protein amine groups, yielding highly stable fluorescent conjugates. This persistent labeling enables precise tracking of cell division through progressive fluorescence halving, facilitating the quantitative analysis of lymphocyte proliferation and immune cell dynamics in clinical studies of HIV infections.

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>).