Several clinical trials are currently evaluating interventions related to stroke and associated cerebrovascular disorders, focusing on stroke recovery, clinical outcomes, and healthcare utilization in post-stroke populations. Sponsored primarily by academic and healthcare institutions, these studies range from not yet recruiting to actively recruiting participants. Their phase designations are classified as unassigned or not applicable, reflecting ongoing efforts to improve healthcare delivery for stroke patients.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06096831 | Not yet recruiting | Stroke|Cerebrovascular Disorders|Cerebrovascular Accident|Healthcare Utilization |
University of Haifa|Ben-Gurion University of the Negev|Clalit Health Services|Carmel Medical Center |
2023-11-15 | -- |
| NCT05816811 | Recruiting | Stroke |
McMaster University |
2023-08-01 | Not Applicable |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
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SIS3 Hydrochloride
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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>).
Note: Technical data last updated: Sep 1, 2026.