Clinical Trials

Numerous clinical trials evaluate fibronectin and fetal fibronectin as predictive biomarkers and therapeutic agents across Phase 1 through 4 studies and non-interventional diagnostic protocols. Conducted by academic institutions and corporate sponsors such as Hologic, Inc., the University Hospital of Limoges, and the University of Liverpool, research primarily targets obstetric conditions—including preterm birth, premature labor, and traumatic abruptio placentae—alongside dry eye syndrome and chronic hepatitis B. These registered studies encompass diverse recruitment statuses, including completed, active not recruiting, terminated, and withdrawn trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07407101 COMPLETED
Dry Eye Syndrome (DES)
University Hospital, Limoges
 2026-04-13
NCT06367166 ACTIVE_NOT_RECRUITING
Varicose Veins of Lower Limb; Varix; Vascular Diseases; Leg Edema
Ryazan State Medical University
 2023-04-01
NCT05300152 COMPLETED
Drug Effect
Suez Canal University
 2022-10-02
NCT04971369 UNKNOWN
Solid Tumor, Adult
Wuxi No. 4 People's Hospital
 2021-08-01
NCT01812239 WITHDRAWN
Premature Birth
Obstetrix Medical Group
 2014-03 PHASE2; PHASE3
NCT01431885 COMPLETED
Preterm Labor; Preterm Delivery
University of California, San Francisco
 2011-08
NCT00641784 TERMINATED
Labor, Premature
MemorialCare
 2008-03 PHASE3
NCT01066533 TERMINATED
Direct Pulp Capping
Mashhad University of Medical Sciences
 2009-10 PHASE4
NCT00005796 COMPLETED
Bone Marrow Suppression; Brain and Central Nervous System Tumors; Drug/Agent Toxicity by Tissue/Organ
Indiana University
 2000-02 PHASE1
NCT00371046 COMPLETED
Preterm Birth
Thomas Jefferson University
 2003-10

(data from https://clinicaltrials.gov, updated on 2026-05-29)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fibronectin functions as a key extracellular matrix glycoprotein that binds cell-surface integrins and matrix molecules like collagen and fibrin, activating intracellular cascades that mediate cell adhesion, migration, and tissue assembly. Disturbance or regulation of these matrix interactions alters cellular scaffold integrity and cell-matrix signaling, which correlates clinically with tissue remodeling in preterm labor and epithelial wound dynamics in dry eye syndrome.

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.