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

NCT04424394 | Unknown Phase 1 FDA Device

• 1 other identifier: BIOINT - 2020DSWJ/ED
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (7)

• Adverse or Severe adverse events associated with Intracavernosal administration of umbilical cord derived Wharton's Jelly injection.

  To determine the safety i.e. adverse or severe adverse events associated with intracavernosal administration of umbilical cord derived Wharton's Jelly injection. Any adverse or severe adverse events will be recorded in the associated case report forms.

  During the procedure

• Adverse or Severe adverse events associated with Intracavernosal administration of umbilical cord derived Wharton's Jelly injection.

  To determine the safety i.e. adverse or severe adverse events associated with intracavernosal administration of umbilical cord derived Wharton's Jelly injection. Any adverse or severe adverse events will be recorded in the associated case report forms.

  1 month follow-up visit

• Adverse or Severe adverse events associated with Intracavernosal administration of umbilical cord derived Wharton's Jelly injection.

  To determine the safety i.e. adverse or severe adverse events associated with intracavernosal administration of umbilical cord derived Wharton's Jelly injection. Any adverse or severe adverse events will be recorded in the associated case report forms.

  3 month follow-up visit

• Adverse or Severe adverse events associated with Intracavernosal administration of umbilical cord derived Wharton's Jelly injection.

  To determine the safety i.e. adverse or severe adverse events associated with intracavernosal administration of umbilical cord derived Wharton's Jelly injection. Any adverse or severe adverse events will be recorded in the associated case report forms.

  6 month follow-up visit

• Adverse or Severe adverse events associated with Intracavernosal administration of umbilical cord derived Wharton's Jelly injection.

  To determine the safety i.e. adverse or severe adverse events associated with intracavernosal administration of umbilical cord derived Wharton's Jelly injection. Any adverse or severe adverse events will be recorded in the associated case report forms.

  12 month follow-up visit

• Adverse or Severe adverse events associated with Intracavernosal administration of umbilical cord derived Wharton's Jelly injection.

  To determine the safety i.e. adverse or severe adverse events associated with intracavernosal administration of umbilical cord derived Wharton's Jelly injection. Any adverse or severe adverse events will be recorded in the associated case report forms.

  18 month follow-up visit

• Immediate and short-term efficacy of DualStim Therapy with Wharton's Jelly based on changes in the International Index of Erectile Function Questionnaire score compared to baseline

  To evaluate the immediate and short-term efficacy of DualStim Therapy with Wharton's Jelly based on changes in the International Index of Erectile Function Questionnaire score compared to baseline score. An increase in the score indicates improvement.

  through study completion, an average of 18 months

Secondary Outcomes (4)

• Immediate and short-term efficacy of DualStim Therapy with Wharton's Jelly compared to DualStim Therapy with saline based on changes in the International Index of Erectile Function Questionnaire score.

  through study completion, an average of 18 months

• Sexual activity improvement according to Sexual Encounter Profile Questionnaire from baseline leading to optimal penetration at follow-ups

  through study completion, an average of 18 months

• Sexual activity improvement according to Global Assessment Questionnaire from baseline leading to optimal penetration at follow-ups

  through study completion, an average of 18 months

• Sexual activity improvement according to Erection Hardness Score from baseline leading to optimal penetration at follow-ups

  through study completion, an average of 18 months

Study Arms (2)

DualStim Therapy with Wharton's Jelly Injection

EXPERIMENTAL

DualStim therapy with intracavernosal injection of umbilical cord-derived Wharton's Jelly formulation.

Device: DualStim Therapy; Biological: Umbilical cord-derived Wharton's Jelly

DualStim Therapy without Wharton's Jelly Injection

ACTIVE COMPARATOR

DualStim therapy with intracavernosal injection of normal saline.

Device: DualStim Therapy; Other: Saline

Interventions

DualStim Therapy DEVICE

6 DualStim Therapies over a period of 7 weeks.

DualStim Therapy with Wharton's Jelly Injection; DualStim Therapy without Wharton's Jelly Injection

Umbilical cord-derived Wharton's Jelly BIOLOGICAL

2 intracavernosal injections over a period of 7 weeks.

DualStim Therapy with Wharton's Jelly Injection

Saline OTHER

2 intracavernosal injections over a period of 7 weeks.

DualStim Therapy without Wharton's Jelly Injection

Eligibility Criteria

• Age: 40 Years - 80 Years
• Gender Eligibility Details: Only Male patients are eligible to participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only Male patients who are 40 to 80 years old (both numbers inclusive).
• Must have a body mass index (BMI) of less than 35.
• Patients with ED for at least 1 year but less than 10 years.
• The patient is poorly phosphodiesterase type 5 inhibitors responsive, meaning he is able to achieve an erection but is unable or partially able to satisfactory complete sexual intercourse (penetration and/or orgasm).
• Minimum IIEF-EF domain score of 11-16 (for classification as moderate ED).
• IIEF-ED score ≥11 and ≤25 while taking phosphodiesterase type 5 inhibitors or in injection therapy.
• Be willing and capable of giving written informed consent to participate in this clinical study.
• Be willing and capable of complying with study-related requirements, procedures and visits.

You may not qualify if:

• Patients with history of radical prostatectomy or extensive pelvic surgery.
• Patients with past radiation therapy of the pelvic region within 12 months prior to enrollment.
• Patients recovering from cancer within 12 months prior to enrollment.
• Patients who are taking blood thinners or have history of Diabetes Mellitus.
• Patients with untreated hypogonadism or thyroid disease.
• Patients with deformed Penis on physical exam form.
• Patients with serious neurological, psychological or psychiatric disorders which may affect erectile function.
• Patients with other medical conditions determined by site principal investigator as interfering with the study.
• Patients with an injury or disability claim under current litigation or pending or approved workers' compensation claim.

Sponsors & Collaborators

• BioIntegrate: lead

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Richard Gaines, MD

  LifeGAINES Medical and Aesthetics Center

  PRINCIPAL INVESTIGATOR

• Ashim Gupta, PhD, MBA

  BioIntegrate

  STUDY DIRECTOR

Central Study Contacts

Richard Gaines, MD

CONTACT

561-931-2430; rg3090@gmail.com

Ashim Gupta, PhD, MBA

CONTACT

agupta@biointegrate.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 11, 2020
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share