Numerous clinical trials evaluate diverse conditions, including light chain amyloidosis, hematologic malignancies, lung cancer, chronic obstructive pulmonary disease, healthspan metrics, and inflammatory articular disorders such as knee osteoarthritis and trochanteric syndrome. Supported by academic medical centers including Memorial Sloan Kettering Cancer Center, Tufts University, and Seoul National University, these studies span Early Phase 1 through Phase 2 as well as unspecified phases. Across active, recruiting, completed, and not yet recruiting stages, these initiatives assess key outcomes including cardiac involvement in amyloidosis.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06917443 | NOT_YET_RECRUITING | Crohn Disease (CD); IBD (Inflammatory Bowel Disease) |
Shmuel Kivity, MD |
2025-04 | |
| NCT07696923 | RECRUITING | Frozen Shoulder; Chronic Pain; Adhesive Capsulitis; Transcatheter Arterial Microembolization; Corticosteroid Injection |
Shin Kong Wu Ho-Su Memorial Hospital |
2026-08-01 | |
| NCT07396246 | RECRUITING | Trochanteric Syndrome |
Unidade Local de Saúde do Alto Ave, EPE |
2026-01-05 | PHASE2 |
| NCT07336849 | RECRUITING | Adhesive Capsulitis of the Shoulder; Frozen Shoulder; Shoulder Adhesive Capsulitis |
Chung-Ang University Hospital |
2025-09-18 | |
| NCT05053750 | ACTIVE_NOT_RECRUITING | Epithelial Ovarian; Fallopian Tube; Primary Peritoneal Cancer |
M.D. Anderson Cancer Center |
2021-12-14 | EARLY_PHASE1 |
| NCT07052916 | RECRUITING | Blood Cancer; Lymphoma; Leukemia; Myeloma |
Memorial Sloan Kettering Cancer Center |
2025-06-27 | |
| NCT07619690 | ACTIVE_NOT_RECRUITING | Anger |
University of Beira Interior |
2025-12-02 | |
| NCT06207851 | UNKNOWN | Osteoarthritis |
Next Biomedical Co., Ltd. |
2023-07-13 | |
| NCT02879136 | COMPLETED | Parkinson's Disease, Idiopathic |
Hubert Fernandez |
2017-01-03 | EARLY_PHASE1 |
| NCT05917028 | RECRUITING | Osteoarthritis |
Next Biomedical Co., Ltd. |
2023-10-23 | |
| NCT05651620 | Recruiting | Calorie Restriction |
Tufts University|Pennington Biomedical Research Center|Washington University School of Medicine|Duke University|National Institute on Aging (NIA) |
2023-04-06 | -- |
| NCT03114033 | UNKNOWN | Out-Of-Hospital Cardiac Arrest |
Australian and New Zealand Intensive Care Research Centre |
2018-02-15 | |
| NCT02015312 | COMPLETED | Light Chain (AL) Amyloidosis; Cardiac Involvement |
Florian Michel |
2013-04 | PHASE2 |
| NCT02554435 | COMPLETED | Physical Activity |
The University of Texas Medical Branch, Galveston |
2016-01 |
(data from https://clinicaltrials.gov, updated on 2025-04-08)
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>).