Several clinical trials evaluate conditions associated with this research domain, including sepsis syndrome, myocardial ischemia, and type 2 diabetes. Ranging from unassigned phases and non-applicable designs to Phase 4 trials, these investigations are sponsored by academic and clinical institutions, including West China Hospital, Triemli Hospital in collaboration with the University of Alberta, and Seoul National University Bundang Hospital. Reflecting terminated or unknown recruitment statuses, these studies collectively assess metabolic, cardiovascular, and inflammatory pathways across diverse patient cohorts.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT03842371 | Unknown status | Sepsis Syndrome |
West China Hospital |
2019-02-11 | -- |
| NCT02407626 | Terminated | Myocardial Ischemia |
Triemli Hospital|University of Alberta |
2015-09 | Not Applicable |
| NCT02315287 | Unknown status | Type 2 Diabetes |
Seoul National University Bundang Hospital |
2014-09 | Phase 4 |
(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>).