Multiple clinical trials sponsored by organizations such as St George's University of London, Neovii Biotech, Assistance Publique - Hôpitaux de Paris, and university hospital networks evaluate interventions for mitochondrial, metabolic, monogenic obesity, cardiovascular, and major depressive disorders. Encompassing Phase 2 protocols alongside observational and unclassified designs, these studies exhibit recruitment statuses ranging from not yet recruiting to withdrawn, including a Phase 2 study investigating erythrocyte-encapsulated thymidine phosphorylase for inborn errors of metabolism.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT03866954 | Withdrawn | Mitochondrial Diseases|Metabolic Disease|Inborn Errors of Metabolism |
St George''s University of London|Neovii Biotech |
2024-11 | Phase 2 |
| NCT06380426 | Not yet recruiting | Monogenic Obesity |
Assistance Publique - Hôpitaux de Paris |
2024-07-01 | -- |
| NCT06391723 | Not yet recruiting | Major Depressive Disorder |
Centre Hospitalier du Rouvray|University Hospital Rouen|Centre Hospitalier Sainte Anne Paris |
2024-06 | Not Applicable |
| NCT06393829 | Not yet recruiting | Cardiovascular Diseases |
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal|Jewish General Hospital |
2024-06-01 | 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>).