Clinical Trials

A clinical trial is currently evaluating the efficacy and safety of polyvinyl alcohol and sodium acrylate embolization microspheres in patients with colorectal cancer liver metastasis. Sponsored by Zhongda Hospital, this prospective, multicenter study has no official phase designation and an unknown recruitment status. Overall, clinical evaluation remains focused on targeted transarterial embolization strategies for secondary hepatic malignancies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06021015 UNKNOWN
Colorectal Cancer Liver Metastasis
Zhongda Hospital
2023-09-10

(data from https://clinicaltrials.gov, updated on 2023-09-01)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a structural monomer in cross-linked polymer microspheres, sodium acrylate facilitates controlled swelling and physical vascular occlusion, thereby blocking downstream arterial blood flow and oxygen delivery to targeted tissues. This mechanical disruption of tumor-feeding blood vessels induces local cellular hypoxia and ischemic necrosis, offering therapeutic utility in the management of colorectal cancer liver metastasis.

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>).

Note: Technical data last updated: Sep 1, 2026.