Clinical Trials

Multiple clinical trials evaluate conditions associated with heparan sulfate pathways, recombinant enzyme derivatives, and specialized therapeutic formulations across Phase I through Phase III studies. Sponsored by academic medical centers and pharmaceutical organizations, these investigations cover indications ranging from Sanfilippo syndrome and vascular conditions to oncological diseases and dermatological scarring. Recruitment statuses across these protocols vary, encompassing completed, active, not yet recruiting, withdrawn, and terminated studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06567769 RECRUITING
Sanfilippo Syndrome Type A
GC Biopharma Corp
2024-11-21 PHASE1
NCT07684833 NOT_YET_RECRUITING
Chronic Venous Disease; Vein Disease; Venous Insufficiency of Leg
Barbara Maglione
2026-11 PHASE3
NCT06052423 Withdrawn
Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Hansoh BioMedical R&D Company
2024-11-30 Phase 2
NCT05928078 Not yet recruiting
Cognitive Decline
University of Castilla-La Mancha
2024-09-01 Not Applicable
NCT06208735 Not yet recruiting
B-Cell Leukemia|Non-Hodgkin''s Lymphoma|B-cell Acute Lymphoblastic Leukemia|Diffuse Large B Cell Lymphoma|High-grade B-cell Lymphoma|Primary Mediastinal Large B-cell Lymphoma (PMBCL)|Mantle Cell Lymphoma|B-cell Lymphoma
British Columbia Cancer Agency
2024-07-01 Phase 1
NCT05470322 Not yet recruiting
Hidradenitis Suppurativa|Scarring
Montefiore Medical Center
2024-06 Not Applicable
NCT06118281 Not yet recruiting
Cardiovascular Risk|Acute Myocardial Infarction (AMI)
Novo Nordisk A/S|Duke Clinical Research Institute
2024-06-25 Phase 3
NCT02350816 TERMINATED
Sanfilippo Syndrome; Mucopolysaccharidosis (MPS)
Shire
2015-04-08 PHASE2
NCT02060526 COMPLETED
Sanfilippo Syndrome
Shire
2014-02-26 PHASE2
NCT01155778 COMPLETED
Mucopolysaccharidosis (MPS)
Shire
2010-06-01 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2025-08-28)

Check the Heparan Sulfate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Heparan sulfate functions as a cell-surface glycosaminoglycan that binds extracellular signaling ligands and cell receptors—such as enhancing Wnt binding in intestinal epithelial cells—thereby activating canonical downstream signaling pathways to stimulate cellular proliferation, matrix organization, and tissue regeneration. This essential involvement in cell-surface receptor binding, signal modulation, and structural turnover underscores its therapeutic relevance in managing lysosomal storage disorders like Sanfilippo syndrome and restoring vascular tissue integrity in chronic venous disease.

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>).

Note: Technical data last updated: Sep 1, 2026.