Multiple clinical trials are currently evaluating interventions—including chemoembolization prior to liver transplantation, hemorrhoidal embolization, and thrombectomy systems—across conditions such as liver cancer, hepatocellular carcinoma, internal hemorrhoids, pulmonary embolism, and musculoskeletal anomalies. Encompassing Phase 2 protocols alongside non-applicable phase designs, these studies are sponsored by academic and commercial entities including Mayo Clinic, RenJi Hospital, Boston Scientific Corporation, Innova Vascular Inc., and Hebei Medical University Third Hospital. Recruitment statuses across these active and planned studies currently range from not yet recruiting to actively recruiting.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06353126 | Not yet recruiting | Liver Cancer |
RenJi Hospital|Boston Scientific Corporation |
2024-06-01 | Phase 2 |
| NCT06106269 | Recruiting | Internal Hemorrhoid |
Mayo Clinic|Terumo Corporation |
2024-06 | -- |
| NCT06041594 | Not yet recruiting | Pulmonary Embolism |
Innova Vascular Inc. |
2024-05 | Not Applicable |
| NCT06272656 | Recruiting | Hepatocellular Carcinoma |
Hebei Medical University Third Hospital |
2024-04-01 | -- |
| NCT06068595 | Not yet recruiting | Musculoskeletal; Anomaly |
Central Hospital Nancy France|University of Lorraine |
2024-04 | Not Applicable |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
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>).