Multiple clinical trials—encompassing Phase 2, Phase 3, and non-phase interventional studies—evaluate the clinical applications and physiological parameters of this intervention. These investigations target conditions including sepsis and septic shock, post-liver transplantation acute kidney injury, workplace-related stress and sleep disorders, and metabolic responses in healthy volunteers. Sponsored by academic institutions and healthcare organizations such as Mansoura University, Assistance Publique - Hôpitaux de Paris, National Taiwan Sport University, and Rigshospitalet Denmark, participant recruitment across these studies ranges from not yet recruiting to actively recruiting.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06302998 | Not yet recruiting | Sepsis|Septic Shock |
Mansoura University |
2024-06 | Phase 2 |
| NCT06344442 | Not yet recruiting | Acute Kidney Injury Post Liver Transplantation |
Assistance Publique - Hôpitaux de Paris |
2024-05-05 | Phase 3 |
| NCT06381479 | Recruiting | Stress|Sleep Disorder |
National Taiwan Sport University|Bened Biomedical Co. Ltd. |
2024-04-19 | Not Applicable |
| NCT06334653 | Not yet recruiting | Healthy Volunteers Only|Energy Metabolism |
Helga Ellingsgaard|Rigshospitalet Denmark |
2024-04-09 | 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>).