Chitosan Clinical Trials

Size	Price	Qty
100mg	USD 79
1g	USD 397

Clinical Trials

Several clinical trials sponsored by academic institutions—including the Medical University of South Carolina, Cairo University, and a collaboration between the Universidade do Porto and Aveiro University—evaluate the biomedical applications of chitosan across diverse clinical indications. Research includes a terminated Phase 1/2 trial assessing chitosan for advanced glycation endproduct modulation in prostate cancer. Additionally, unphased trials investigated nanochitosan for postoperative pain and apical bone healing, as well as the safety of chitosan as a wine fining agent in individuals with shellfish allergy, both of which currently hold an unknown recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03712371	Terminated	Prostate Cancer	Medical University of South Carolina	2019-01-16	Phase 1\|Phase 2
NCT03724266	Unknown status	Postoperative Pain\|Healing	Cairo University	2018-10	Not Applicable
NCT02151279	Unknown status	Shellfish Allergy	Universidade do Porto\|Aveiro University	2014-03	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a polycationic linear polysaccharide, chitosan electrostatically binds negatively charged phospholipids and lipopolysaccharides on cellular membranes, disrupting structural membrane integrity and inhibiting downstream metabolic pathways to induce microbial cell lysis and suppress tumor cell proliferation. These membrane-disrupting, antimicrobial, and antitumor mechanisms provide the functional basis for evaluating chitosan across clinical contexts, including advanced glycation endproduct manipulation in prostate cancer and the mitigation of postoperative pain and apical bone healing.

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>).