Multiple clinical trials evaluate applications associated with this designation, primarily exploring cardiovascular conditions such as heart failure, ischemic cardiomyopathy, and left bundle-branch block, alongside myofascial pain syndromes and schizophrenia. Comprising Phase 1 investigations and unclassified evaluations, these studies are funded by diverse industry and academic sponsors, including Abbott Medical Devices, Biotronik, Inc., Oxford University Hospitals NHS Trust, and University Hospitals Cleveland Medical Center. Recruitment statuses across the portfolio range from completed and unknown to terminated and withdrawn.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04827147 | COMPLETED | Homonymous Hemianopia |
Massachusetts Eye and Ear Infirmary |
2023-04-03 | |
| NCT04334018 | WITHDRAWN | Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization Therapy |
CMC Ambroise Paré |
2018-03-01 | |
| NCT03567096 | COMPLETED | Heart Failure; Left Bundle-Branch Block |
Abbott Medical Devices |
2018-10-09 | |
| NCT02576613 | COMPLETED | Schizophrenia; Schizoaffective Disorder |
Charite University, Berlin, Germany |
2015-10 | |
| NCT02006069 | TERMINATED | Heart Failure |
Abbott Medical Devices |
2013-12 | |
| NCT03220659 | COMPLETED | Heart Failure, Systolic |
University of Leeds |
2017-11-01 | |
| NCT03155724 | COMPLETED | Heart Failure |
Biotronik, Inc. |
2017-05-19 | |
| NCT02476201 | COMPLETED | Heart Failure |
Abbott Medical Devices |
2016-02 | |
| NCT05287061 | COMPLETED | Acute Coronary Syndrome |
Hospital Universitario 12 de Octubre |
2017-07-17 | |
| NCT03187470 | COMPLETED | Heart Failure，Congestive |
Adnan Kastrati, MD |
2017-03-01 | |
| NCT04066738 | TERMINATED | Heart Failure; Ischemic Cardiomyopathy |
Oxford University Hospitals NHS Trust |
2017-09-27 | |
| NCT02402816 | UNKNOWN | Heart Failure |
Humanitas Hospital, Italy |
2016-05 | |
| NCT02173405 | COMPLETED | Myofascial Pain Syndromes; Myofascial Trigger Point Pain; Trigger Point Pain, Myofascial |
University Hospitals Cleveland Medical Center |
2014-08-01 | PHASE1 |
| NCT01846143 | COMPLETED | Melanoma |
Craig L Slingluff, Jr |
2013-05 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-08-19)
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>).