Several clinical trials are evaluating therapeutic interventions across neurodegenerative, psychiatric, and cerebrovascular conditions, specifically targeting Parkinson's disease, major and persistent depressive disorders, and stroke. Ranging from Phase 1 and Phase 2 protocols to studies categorized as Not Applicable, all entries are currently in a not yet recruiting status. Sponsored by entities including the VA Office of Research and Development, the University of Pennsylvania in conjunction with the National Institutes of Health, and UMC Utrecht, these investigations focus on neuroplasticity, subgenual cingulate stimulation, and post-stroke motor recovery.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06231563 | Not yet recruiting | Parkinson?s Disease |
VA Office of Research and Development |
2024-07-01 | Phase 2 |
| NCT06266390 | Not yet recruiting | Depression|Major Depressive Disorder|Persistent Depressive Disorder |
University of Pennsylvania|National Institutes of Health (NIH) |
2024-06-30 | Phase 1 |
| NCT06381388 | Not yet recruiting | Stroke |
Jord Vink|UMC Utrecht |
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>).