Multiple clinical trials evaluate therapeutic, diagnostic, and rehabilitative interventions across diverse indications, including breast cancer, stroke-related hemiplegia, vestibular schwannoma, autism spectrum disorder, mild cognitive impairment, opioid use disorder, and Parkinson's disease. Ranging from Phase 3 to non-interventional or unclassified protocols, these studies are sponsored by major academic medical centers and healthcare networks such as Karolinska University Hospital, King's College Hospital NHS Trust, and the University of California, Los Angeles. Recruitment statuses encompass completed, active, recruiting, and active-not-recruiting protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07660978 | NOT_YET_RECRUITING | PARKINSON DISEASE (Disorder); Parkinson Disease (PD); Parkinson s Disease; Postural Instability; Postural Instability Gait Disorders; Gait Disorders; Cognitive Dysfunction, Cognitive Disorder |
Bezmialem Vakif University |
2026-06-20 | |
| NCT03883139 | ACTIVE_NOT_RECRUITING | Autism Spectrum Disorder |
University of California, Los Angeles |
2021-03-01 | |
| NCT07209982 | COMPLETED | Hemiplegia; Hemiplegia Following Ischemic Stroke; Stroke |
University of Lahore |
2025-01-15 | |
| NCT04057976 | COMPLETED | Vestibular Schwannoma |
King's College Hospital NHS Trust |
2019-06-27 | |
| NCT05730790 | UNKNOWN | Mild Cognitive Impairment |
Tan Tock Seng Hospital |
2021-03-31 | |
| NCT06255119 | Completed | Opioid Use Disorder |
3D Therapy LLC |
2022-10-18 | Not Applicable |
| NCT04057976 | Recruiting | Vestibular Schwannoma |
King''s College Hospital NHS Trust|Guy''s and St Thomas'' NHS Foundation Trust |
2019-06-27 | Not Applicable |
| NCT01751698 | COMPLETED | Autism |
University of California, Los Angeles |
2013-01 | |
| NCT00798070 | ACTIVE_NOT_RECRUITING | Breast Cancer |
Karolinska University Hospital |
2007-02 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-06-25)
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>).