Clinical Trials
Several clinical trials evaluate conditions in oncology care, neuropathic symptoms, and rare genetic disorders, including breast and gynecologic cancers, pediatric infection risks, chemotherapy-induced peripheral neuropathy, and Krabbe disease. Spanning Phase 2 protocols and non-interventional classifications, these studies are supported by academic institutions, cooperative research groups, and industry sponsors. Recruitment across these entries is primarily documented as not yet recruiting, alongside a clinical trial marked as withdrawn.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05940766 | Not yet recruiting | Pediatric Oncology Patients With Risk for Infections |
Insel Gruppe AG University Hospital Bern|ETH Zurich |
2024-10-01 | Not Applicable |
| NCT05689359 | Withdrawn | Breast Cancer|Gynecologic Cancer|Early-stage Breast Cancer|Peripheral Neuropathy|Chemotherapy-induced Peripheral Neuropathy |
University of Arizona |
2024-06 | Phase 2 |
| NCT06078384 | Not yet recruiting | Triple-negative Breast Cancer |
UNICANCER|MSD France|Vall d''Hebron Institute of Oncology|SOLTI Breast Cancer Research Group |
2024-06-30 | Phase 2 |
| NCT06308718 | Not yet recruiting | Krabbe Disease |
Forge Biologics Inc |
2024-06 | -- |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Compliance for Clinical Use
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>).