Sodium Hyaluronate Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Multiple registered clinical trials evaluate the therapeutic utility of sodium hyaluronate for indications including Parkinson disease-associated chronic constipation, oral mucositis and pain in pediatric oncology patients, and shoulder osteoarthritis accompanied by joint pain and motion limitation. These Phase 2, Phase 3, and non-applicable phase studies report completed or unknown recruitment statuses. Research sponsors include IRCCS San Raffaele Roma, Sanofi, and the Children's Cancer and Leukaemia Group in collaboration with the National Cancer Institute.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04569656	Completed	Parkinson Disease	IRCCS San Raffaele Roma	2016-02-02	Phase 2
NCT00349024	Unknown status	Brain and Central Nervous System Tumors\|Chordoma\|Kidney Cancer\|Leukemia\|Lymphoma\|Mucositis\|Neuroblastoma\|Pain\|Sarcoma\|Unspecified Childhood Solid Tumor Protocol Specific	Children''s Cancer and Leukaemia Group\|National Cancer Institute (NCI)	2005-07	Not Applicable
NCT00377624	Completed	Osteoarthritis of Shoulder	Sanofi	2002-01	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a high-molecular-weight glycosaminoglycan, sodium hyaluronate binds to cell-surface receptors such as CD44 and hyaluronan-mediated motility receptors, forming a viscoelastic protective matrix that restores tissue hydration and attenuates inflammatory signaling cascades. This structural lubrication and cell-protective mechanism directly supports its therapeutic application in alleviating pain and tissue damage associated with shoulder osteoarthritis, oral mucositis, and gastrointestinal dysmotility in clinical trials.

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>).