Dextran Clinical Trials

Size	Price	Qty
100mg	USD 97
1g	USD 217

Clinical Trials

Several clinical trials evaluate dextran formulations across applications such as anti-Xa activity assessment in heparinized patients, post-surgical lymphatic drainage in upper arm lymphedema, and contrast imaging for osteomyelitis. Ranging from unassigned phases up to Phase 1, these studies are sponsored by academic and hospital entities, including Rennes University Hospital, Peking University People's Hospital, and the University of New Mexico. The records comprise completed investigations as well as trials with an unknown recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04700670	Completed	Unfractionated Heparin Treatment	Rennes University Hospital	2020-01-16	--
NCT02691624	Unknown status	Lymphedema of Upper Arm	Peking University People''s Hospital	2015-10	--
NCT05959590	Completed	Osteomyelitis	University of New Mexico	2014-02-12	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dextran functions as a biocompatible polysaccharide macromolecule that expands intravascular volume and acts as a drug delivery vehicle by increasing plasma oncotic pressure and colloidal stability. This macromolecular retention and fluid movement support its therapeutic and diagnostic utility in evaluating unfractionated heparin activity, characterizing upper arm lymphedema pathways, and facilitating contrast-enhanced magnetic resonance imaging of osteomyelitis.

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>).