Multiple clinical trials evaluate interventions across conditions such as apnea of prematurity, respiratory distress syndrome, amyotrophic lateral sclerosis, osteoarthritis, and Crohn disease. Supported by academic medical centers, hospital institutes, and commercial entities—including the University of California, Irvine, Insel Gruppe AG, and Corin—these Phase 2, Phase 4, and non-applicable phase studies demonstrate a broad research scope. The dataset encompasses varied recruitment statuses, including actively recruiting, completed post-approval, terminated, and unknown trials.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06327152 | Recruiting | Apnea of Prematurity |
University of California Irvine |
2024-02-22 | Phase 2 |
| NCT02096211 | COMPLETED | Non-inflammatory Degenerative Joint Disease; Osteoarthritis; Avascular Necrosis; Post-Traumatic Osteoarthritis of Hip |
DePuy Orthopaedics |
2014-06-01 | |
| NCT05908227 | Recruiting | Respiratory Distress Syndrome |
Insel Gruppe AG University Hospital Bern |
2023-07-01 | Not Applicable |
| NCT06318585 | Recruiting | Amyotrophic Lateral Sclerosis|Motor Neuron Disease |
Istituto Auxologico Italiano |
2023-04-03 | -- |
| NCT06087666 | Recruiting | Preterm |
Instituto de Investigación Hospital Universitario La Paz |
2023-02-01 | Not Applicable |
| NCT05178719 | COMPLETED | Osteoporosis |
Polyclinic K-center |
2016-03-16 | |
| NCT04370535 | UNKNOWN | Crohn Disease |
Ciim Plus, d.o.o. |
2018-10-17 | |
| NCT03803306 | COMPLETED | Essential Hypertension |
NMP Medical Research Institute |
2018-07-12 | |
| NCT02528318 | TERMINATED | Respiratory Distress Syndrome |
Windtree Therapeutics |
2015-08 | PHASE2 |
| NCT04607018 | COMPLETED | Effects of the Elements |
General Hospital Pula |
2015-11-17 | |
| NCT02074059 | COMPLETED | Respiratory Distress Syndrome |
Windtree Therapeutics |
2014-02 | PHASE2 |
| NCT00722007 | COMPLETED | Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis |
Corin |
2008-04-24 | |
| NCT00546598 | TERMINATED | Non-inflammatory Joint Disease; Osteoarthritis; Avascular Necrosis; Congenital Hip Dysplasia; Post-traumatic Arthritis |
DePuy Orthopaedics |
2006-01-01 | PHASE4 |
(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>).
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