Clinical Trials
Numerous clinical trials evaluate dextran sulfate sodium or dextran sulfate-based therapeutic systems, predominantly focusing on HIV infections, preeclampsia, homozygous familial hypercholesterolemia, and various oncological and cardiovascular disorders. These Phase 1, Phase 2, and Phase 4 studies range in status from completed to recruiting and not yet recruiting. Research is supported by academic institutions, hospitals, and government sponsors, including the National Institute of Allergy and Infectious Diseases, Massachusetts General Hospital, and Laval University.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05710380 | RECRUITING | Prostate Cancer; Prostate Adenocarcinoma; Prostate Neoplasm |
University of Chicago |
2023-04-26 | |
| NCT07246122 | RECRUITING | Adolescent Idiopathic Scoliosis |
Chinese University of Hong Kong |
2023-07-27 | |
| NCT07063420 | RECRUITING | Type 2 Diabetes Treated With Insulin |
Daniel Chernavvsky, MD |
2025-10-28 | |
| NCT06730282 | UNKNOWN | Primary Dysmenorrhea (PD); Traditional Chinese Medicine (TCM) Approaches |
Taichung Tzu Chi Hospital |
2024-12-01 | |
| NCT04653961 | UNKNOWN | Type1diabetes |
Rabin Medical Center |
2020-06-01 | |
| NCT07079787 | NOT_YET_RECRUITING | Stroke; Mild Cognitive Impairment (MCI); Vestibular Disease; Long Covid-19 |
University College, London |
2025-07-25 | |
| NCT06452004 | UNKNOWN | HPV Infection; Cervix Cancer; Cervical Dysplasia |
University Medical Center Groningen |
2022-10-01 | |
| NCT05844566 | COMPLETED | Acute Coronary Syndrome; Myocardial Infarction |
Imperial College London |
2023-04-03 | |
| NCT05885490 | Not yet recruiting | Head Cancer Neck |
Royal Marsden NHS Foundation Trust |
2024-07 | -- |
| NCT06381180 | Not yet recruiting | Post Traumatic Stress Disorder|Cannabis Use|Suicide|Veterans|Marijuana |
Wayne State University |
2024-05-01 | Phase 1|Phase 2 |
| NCT06348264 | Recruiting | Salivary Gland Neoplasm Duct |
Peking University First Hospital|Jiangsu Hengrui Pharmaceutical Co. Ltd.|Beijing Biote Pharmaceutical Co.Ltd |
2024-03-30 | Phase 2 |
| NCT03585660 | COMPLETED | Prostate Cancer |
University of Chicago |
2018-08-28 | |
| NCT05047211 | COMPLETED | Anemia, Iron Deficiency; Delivery Complication |
The University of Texas Medical Branch, Galveston |
2021-10-07 | PHASE4 |
| NCT02779725 | COMPLETED | Cancer |
University of Utah |
2017-08-07 | |
| NCT03258268 | COMPLETED | Type 2 Diabetes Mellitus |
Läkarexpressen AB |
2017-08-07 | |
| NCT02928666 | UNKNOWN | Type 2 Diabetes Mellitus; Lung Diseases, Obstructive; Osteoporosis; Hypertension; Osteoarthritis |
Rambam Health Care Campus |
2018-10 | |
| NCT03093636 | COMPLETED | Type1 Diabetes Mellitus |
University of Virginia |
2017-04-17 | |
| NCT05510531 | COMPLETED | Diabetes |
University of Connecticut |
2017-03-08 | |
| NCT02704819 | COMPLETED | Dizziness; Vertigo |
University College, London |
2016-03 | |
| NCT01461005 | TERMINATED | Spondylolisthesis; Neurologic Deficits; Kyphosis; Pseudarthrosis |
Paradigm Spine |
2011-09 | |
| NCT01404910 | COMPLETED | Preeclampsia |
Massachusetts General Hospital |
2013-05 | |
| NCT01794052 | COMPLETED | Hypertension; Type 2 Diabetes Mellitus |
Centre for Chronic Disease Control, India |
2012-12 | |
| NCT00000684 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
||
| NCT00000690 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE1 | |
| NCT00001009 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-09-01)
Check the
Dextran sulfate sodium (DSS)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
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>).
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Note: Technical data last updated: Sep 1, 2026.