MyoStim ED

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bioMyoStim ED is focused on bioelectric bandage stimulation and stem cell/growth factor regeneration treatment 

of erectile dysfunction (ED).  This Leonhardt Ventures founded startup is incubating in the Cal-X Stars Business Accelerator, Inc. in Santa Monica, CA and at Leonhardt’s Launchpads Utah.

The MyoStim ED product is a micro stimulator connected to a bandage wrap that is placed around the ED tissue area to be treated.  The micro stimulator causes the treated tissue to release SDF-1 (stem cell homing signal), eNOS and VEGF for improving blood flow), Follistatin (for muscle regeneration), IGF-1 (DNA repair), HGF (for regeneration), Activin (for regeneration) and Tropoelastin (for improving elasticity of treated tissues).  The bandage wrap is applied 20 minutes a day three times a week for 16 weeks in the suggested treatment protocol (early stage research investigational use only).  Previous studies have documented the use of stem cells and growth factors injected by a needle and syringe or induced by drug intake.  This is the first product designed to provide multiple therapeutic treatment modalities locally without the need for painful needle injections. 


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Bioelectrical Stimulation + Stem Cell Composition Mix for Erectile Dysfunction

This study is not yet currently recruiting participants. (see Contacts and Locations)

Verified July 2016 by MyoStim ED Leonhardt Ventures 


MyoStim ED a Leonhardt Ventures Co. 


Harbor UCLA LABioMed

Information provided by (Responsible Party):

Howard Leonhardt, Executive Chairman MyoStim ED Leonhardt Ventures Identifier:

First received:  TBD

Last updated: TBD

Last verified:  July 2016

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Bioelectric stimulation control of protein releases + Autologous Fat Derived Stem Cell Mix Composition treatment of ED.

To assess safety and primary efficacy of bioelectric stimulation of SDF-1, Follistatin, IGF-1, HGF, EGF, eNOS, VEGF, Activin A+B, Tropoelastin + stem cell  based cocktail infusion in refractory ED.

To investigate the success rate and durability of success of using this new therapy in management of moderate and severe cases of erectile dysfunction.




Erectile Dysfunction

Procedure: liposuction for retrieval of own stem cells from fat cells + bioelectric stimulation delivery

Phase 2

Study Type:


Study Design:

Allocation: Randomized

Endpoint Classification: Safety/Efficacy Study

Intervention Model: Crossover Assignment

Masking: Open Label

Primary Purpose: Treatment

Official Title:

BioStim ED – Phase 1 Study of Bioelectric Stimulation + Stem Cell Based Mix Composition in Men With Erectile Dysfunction

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

U.S. FDA Resources 

Further study details as provided by MyoStim ED Leonhardt Ventures 

Primary Outcome Measures:

  • Adverse Events that occur during or after the procedure to measure safety and tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] to assess efficacy and safety of injection of stem autologous stem cells in penis of ED patients

Estimated Enrollment:


Study Start Date:


Estimated Study Completion Date:

May 2018

Estimated Primary Completion Date:

TBD – (Final data collection date for primary outcome measure)


Assigned Interventions

Active Comparator: bioelectric stimulation via bandage wrap + stem cell mix composition infusion in penis

Treatment bioelectric stimulation + adipose derived cells based mix composition into penis experimental; randomised

Procedure: liposuction for retrieval of own stem cells from fat cells, bioelectric stimulation applied. 

No Intervention: control arm


Ages Eligible for Study:  

40 Years to 70 Years   (Adult, Senior)

Genders Eligible for Study:  


Accepts Healthy Volunteers:  



Inclusion Criteria:

  • Male 40 years old and older suffering from moderate to sever erectile dysfunction –

Exclusion Criteria:

  • Inability to give informed consent or attend follow up
  • Severe diabetic neuropathy (to be defined ? Charcot joints, diabetic ulcers?) or other neuropathic disease
  • Viral disease from infectivity viewpoint
  • Major penile fibrosis or severe Peyronie’s disease
  • Severe primary large vessel ED (defined as PSV less than 15cm/s after ICI)
  • Severe primary venous leakage ED (defined as EDV more than 10cm/s after ICI)
  • Prior systemic chemotherapy, or radiotherapy to donor or recipient area
  • Not in potentially active sexual relationship
  • Age less than 40 or over 70

  Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies. 

Please refer to this study by its identifier: =



Sponsors and Collaborators

MyoStim ED Leonhardt Ventures



Study Director:  TBD 

  More Information

Responsible Party:

TBD Identifier:

Other Study ID Numbers:

Study First Received:


Last Updated:


Health Authority:


Keywords provided 

stem cells injections

erectile dysfunction

bioelelectric stimulation 

Additional relevant MeSH terms:

Erectile Dysfunction

Sexual Dysfunction, Physiological

Genital Diseases, Male

Sexual Dysfunctions, Psychological

Mental Disorders processed this record **** TBD 

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