Multiple clinical trials sponsored by academic and medical institutions, including McMaster University, University of Haifa, Ben-Gurion University of the Negev, Clalit Health Services, and Carmel Medical Center, are evaluating interventions related to stroke, cerebrovascular disorders, and healthcare utilization. Operating under unassigned or non-applicable trial phases, these investigations focus on post-stroke recovery feasibility and sustainable healthcare resource management. Recruitment status across the protocols varies, with some currently recruiting participants and others not yet recruiting.
| 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)
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>).