Several clinical trials evaluate interventions across conditions such as colorectal cancer, deep vein thrombosis, SARS-CoV-2 infection with acute kidney injury, and mesenteric traction syndrome. Ranging from Phase 1/Phase 2 to Phase Not Applicable or unassigned studies, these trials are primarily sponsored by academic medical centers and major hospital networks, including the University of Chicago, RenJi Hospital, University of California San Francisco, and Rigshospitalet Denmark. The studies reflect various recruitment statuses, currently encompassing those that are not yet recruiting, actively recruiting, and active but not recruiting.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06349590 | Not yet recruiting | Colorectal Cancer |
University of Chicago |
2024-04 | Phase 1|Phase 2 |
| NCT05286710 | Recruiting | Deep Vein Thrombosis |
RenJi Hospital|First People''s Hospital of Hangzhou|The First Affiliated Hospital with Nanjing Medical University|Affiliated Hospital of Nantong University|Chengdu University of Traditional Chinese Medicine|Second Affiliated Hospital of Suzhou University|Liuzhou Workers Hospital|Shanghai Pudong New Area People''s Hospital|Zhejiang University |
2022-10-26 | Not Applicable |
| NCT05356767 | Recruiting | Pharmacomechanical Thrombolysis|Deep Vein Thrombosis |
Chengdu University of Traditional Chinese Medicine |
2022-04-01 | -- |
| NCT04705766 | Recruiting | SARS-CoV Infection|Covid19|Corona Virus Infection|Acute Kidney Injury|Kidney Injury |
University of California San Francisco|Rush University Medical Center|University of Michigan|University of California |
2021-03-01 | -- |
| NCT04796493 | Active not recruiting | Mesenteric Traction Syndrome |
Rigshospitalet Denmark |
2021-03-16 | -- |
(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>).