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

Study Overview
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Brief Summary
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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).

Detailed Description
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Erectile Dysfunction (ED) is broadly defined as the inability to achieve or maintain an erection sufficient for sexual intercourse or activity. Current treatment for ED consists of oral medications, vacuum devices, intracavernosal injections, and surgically placed penile prosthetics. In the literature, this has been described as a Stepwise Approach, offering therapy beginning with the least invasive treatment option. The low intensity extracorporeal shock wave therapy (LISWT) was recently approved by the FDA for treatment of diabetic ulcers. But it is still under evaluation for treatment of ED. Recently, the European Association of Urology updated their guidelines related to ED and included LISWT for men with mild to moderate ED. Studies have reported that LISWT can be effective in treating ED. This was attributed to increase in angiogenesis, neurogenesis and other rejuvenating tissue effects. Doppler ultrasound studies have demonstrated a sustained increase in blood flow in patients treated with LISWT. Published studies have also reported a response rate of 40-80% with this treatment. In addition, the energy/pulse used in this application is approximately 10% of the energy used for disintegrating kidney stones; and no serious side effects have been reported till date. Additionally, most completed studies included men who score in the moderate to minimal ranges on the International Index of Erectile Function. In the proposed study, men with severe to moderate ED based on IIEF-EF score will be included. The goal of this study is to improve and/or restore erectile function in men with erectile dysfunction. The investigators hypothesize (Alternate Hypothesis) that patients in the active treatment group (DualStim + Wharton's Jelly) will show an improvement of at least 4 points for moderate ED and at least 7 points for severe ED on IIEF-EF scale/questionnaire, and this difference will be significantly different from their baseline. In addition, patients in the DualStim + Saline group will be significantly different from their baseline, however, will show less improvement compared to DualStim + Wharton's Jelly. Our null hypothesis is that there is no difference between DualStim with Saline and DualStim with Wharton's Jelly groups and no difference between the baseline and after-treatment within the treatment groups for alleviating ED measured using International Index of Erectile Function score (IIEF-EF).

Official Title
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A Pilot Study to Evaluate the Immediate and Short-term Efficacy of DualStim (Focused and Radial Extracorporeal Shock Wave) Therapy With and Without Intracavernosal Wharton's Jelly in Patients With Erectile Dysfunction

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Device: DualStim Therapy
* Biological: Umbilical cord-derived Wharton's Jelly
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 who participated in another clinical trial or treatment with any investigational product within last 30 days prior to inclusion in the study. 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DualStim Therapy with Wharton's Jelly Injection<br>DualStim therapy with intracavernosal injection of umbilical cord-derived Wharton's Jelly formulation. | Device: DualStim Therapy<br>* 6 DualStim Therapies over a period of 7 weeks.<br>Biological: Umbilical cord-derived Wharton's Jelly<br>* 2 intracavernosal injections over a period of 7 weeks.<br>|
| Active Comparator: DualStim Therapy without Wharton's Jelly Injection<br>DualStim therapy with intracavernosal injection of normal saline. | Device: DualStim Therapy<br>* 6 DualStim Therapies over a period of 7 weeks.<br>Other: Saline<br>* 2 intracavernosal injections over a period of 7 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | To evaluate the 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 at each time-point. | 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 | To study sexual activity improvement from baseline leading to optimal penetration at follow-ups 1, 3 and 6 months' post treatment according to Sexual Encounter Profile Questionnaire. An increase in score indicates improvement. | 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 | To study sexual activity improvement from baseline leading to optimal penetration at follow-ups 1, 3 and 6 months' post treatment according to Global Assessment Questionnaire. An increase in score indicates improvement. | 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 | To study sexual activity improvement from baseline leading to optimal penetration at follow-ups 1, 3 and 6 months' post treatment according to Erection Hardness Score. An increase in score indicates improvement. | through study completion, an average of 18 months |