Clinical Trials

Multiple clinical trials evaluate this compound or related interventions across diverse indications, including pancreatic exocrine insufficiency, pancreatic adenocarcinoma, prostate cancer, type 1 diabetes, head and neck carcinoma, oral health conditions, and septic shock requiring hemoadsorption. Encompassing Early Phase 1, Phase 1, and unclassified protocols, these studies maintain recruitment statuses ranging from active recruitment and enrollment by invitation to completed. Prominent academic medical centers and private institutions, such as Vanderbilt University Medical Center and Bühlmann Laboratories AG, sponsor these biomedical research efforts.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05644821 Recruiting
Prostate Cancer
Heinrich-Heine University Duesseldorf|Marienhospital Herne|University Hospital Essen|University Hospital Bonn|Klinikum Dortmund gGbmH|University Hospital Muenster|University Hospital of Cologne|University of Cologne|Techniker Krankenkasse|Deutsche Krebsgesellschaft e.V.
 2023-08-01 Not Applicable
NCT05804409 Not yet recruiting
Pancreatic Exocrine Insufficiency
Assiut University
 2023-06 --
NCT05266963 Enrolling by invitation
Type 1 Diabetes
Vanderbilt University Medical Center
 2022-09-02 Early Phase 1
NCT05244174 Recruiting
Pancreatic Neoplasm Malignant Head Primary|Pancreatic Exocrine Insufficiency
Hospital Clinico Universitario de Santiago
 2022-01-25 Not Applicable
NCT04548778 Recruiting
Exocrine Pancreatic Insufficiency
Bühlmann Laboratories AG
 2020-11-01 --
NCT01274455 COMPLETED
Pancreatic Adenocarcinoma
University Hospital, Toulouse
 2010-12 PHASE1
NCT01007240 UNKNOWN
Carcinoma of Head and Neck
Hadassah Medical Organization
 2010-01 PHASE1

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

Check the Polyethylenimine (branched) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a hydrophilic cationic polymer, branched polyethylenimine electrostatically binds negatively charged nucleic acids to form stable nanocomplexes, protecting genetic payloads from enzymatic degradation and enhancing cellular uptake via endocytosis. Following endosomal escape through the proton sponge mechanism, the delivered nucleic acids achieve functional intracellular gene expression, providing therapeutic gene delivery capabilities relevant to clinical trials in oncology, sepsis, and pancreatic disorders.

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.