NCT04424394 is a Phase 1, PHASE2 clinical trial of DualStim Therapy in Erectile Dysfunction, sponsored by BioIntegrate.

Who is sponsoring NCT04424394?

NCT04424394 is sponsored by BioIntegrate.

What drugs are being tested in NCT04424394?

Interventions in NCT04424394: DualStim Therapy, Umbilical cord-derived Wharton's Jelly, Saline.

What condition does NCT04424394 study?

NCT04424394 studies Erectile Dysfunction.

Is NCT04424394 still recruiting?

NCT04424394 is currently status unknown. Last updated 21 July 2022.

Last reviewed 2022-07-21 · How we verify

NCT04424394

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

DualStim Therapy With or Without Umbilical Cord Derived Wharton's Jelly for Erectile Dysfunction

Status unknown Phase 1, PHASE2 Last updated 21 July 2022

What this trial tests

Phase 1, PHASE2 trial testing DualStim Therapy in Erectile Dysfunction in 60 participants. Status unknown.

Timeline

1 January 2023

Primary endpoint
31 December 2024

31 December 2024

Quick facts

Lead sponsor	BioIntegrate
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	1 January 2023
Primary completion	31 December 2024
Estimated completion	31 December 2024

Drugs / interventions tested

DualStim Therapy
Umbilical cord-derived Wharton's Jelly — full drug profile →
Saline

Conditions studied

Erectile Dysfunction — all drugs for Erectile Dysfunction →

Sponsor

BioIntegrate — full company profile →

Who can join

Adults 40 to 80, male only, with Erectile Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to determine the immediate and short-term efficacy of the methodological application of DualStim Therapy - Focused Extracorporeal Shock Wave Therapy (fESWT) and Radial Extracorporeal Shock Wave Therapy (rESWT), with and without intracavernosal administration of formulated umbilical cord derived Wharton's Jelly to improve and/or restore erectile function in patients with erectile dysfunction (ED).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Evaluation of immediate and short-term efficacy of DualStim therapy with and without intracavernosal umbilical cord-derived Wharton's jelly in patients with erectile dysfunction: Study protocol for a randomized controlled trial.
Gupta A, Rodriguez HC, Delfino K, Levy HJ, et al · · 2021 · cited 2× · PMID 34278040 · DOI 10.1016/j.conctc.2021.100790
Evaluation of Immediate and Short-Term Efficacy of DualStim Therapy with and without Intracavernosal Umbilical Cord-Derived Wharton’s Jelly in Patients with Erectile Dysfunction: Study Protocol for a Pilot Randomised Controlled Trial
Gupta A, Rodriguez HC, Delfino K, Levy HJ, et al · · 2020 · DOI 10.21203/rs.3.rs-47585/v1

Verify or expand the search:

Other recruiting trials for Erectile Dysfunction

Currently open trials in the same condition.

NCT07442396 — The Effectiveness of Exercise in the Treatment of Erectile Dysfunction and Premature Ejaculation · NA · recruiting
NCT07366970 — Is There a Benefit From Addition of Exercise in Diabetic Patients With ED Who Complain Low Vitamin D? · NA · recruiting
NCT06960746 — Changing Lifestyle in OSA Males Who Suffer Metabolic Syndrome and Impotence: Is There a Response? · NA · recruiting
NCT06872866 — The Objective of This Phase 1 Study is to Evaluate the Food Effect of 100 mg Hezkue Turbo® (ASP-001.1, Sildenafil) Under · Phase 1 · recruiting
NCT06805513 — Actual Use Trial of Tadalafil 5 mg · Phase 3 · recruiting

Other BioIntegrate trials

Trials by the same sponsor.

NCT04719793 — Umbilical Cord Derived Wharton's Jelly for Knee Osteoarthritis · EARLY_PHASE1 · unknown
NCT04711304 — Evaluation of Safety and Efficacy of Wharton's Jelly Compared to Hyaluronic Acid and Saline for Knee Osteoarthritis. · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04424394 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BioIntegrate
Last refreshed: 21 July 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04424394.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing