Chondroitin 4-sulfate Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Several clinical trials investigate chondroitin 4-sulfate across diverse conditions, focusing primarily on musculoskeletal and joint disorders alongside rare systemic diseases. These non-interventional or unassigned studies encompass various recruitment statuses—including recruiting, active, completed, and enrolling by invitation—to evaluate joint health outcomes and biochemical biomarkers. Sponsoring organizations mainly comprise academic institutions and university hospitals collaborating with funding bodies and industry partners.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05306054	Recruiting	Anterior Cruciate Ligament Injuries\|Anterior Cruciate Ligament Rupture\|Anterior Cruciate Ligament Tear\|Post-traumatic Osteoarthritis\|Anterior Cruciate Ligament Reconstruction	University of Bath\|Versus Arthritis	2022-06-01	--
NCT05323370	Completed	Lymphangioleiomyomatosis\|Tuberous Sclerosis Complex	University Hospital Tours	2022-05-31	--
NCT04507074	Active not recruiting	Low Back Pain\|Obesity	Poznan University of Physical Education	2020-09-01	Not Applicable
NCT04618237	Enrolling by invitation	Hemophilia\|Arthropathy	Taipei Medical University Hospital\|Sanofi	2020-07-20	--

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

Check the Chondroitin 4-sulfate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Chondroitin 4-sulfate integrates into the extracellular matrix of articular cartilage, where its negatively charged sulfate groups bind extracellular water and inhibit pro-inflammatory mediators and catabolic enzymes such as matrix metalloproteinases, thereby preserving chondrocyte integrity and suppressing matrix breakdown. Consequently, this biochemical maintenance of cartilage structure and suppression of degradation pathways provide therapeutic relevance for mitigating joint discomfort, post-traumatic osteoarthritis, and arthropathy conditions investigated 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>).