MyoStim ED

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. 

Scientific Related Articles

Regenerative technology for future therapy of erectile dysfunction …

tau.amegroups.com/article/view/1064/1288

by JK Ryu – ‎2012 – ‎Cited by 1 – ‎Related articles

Regenerative technology for future therapy of erectile dysfunction. … smooth muscle relaxation, endothelial nitric oxide synthase (eNOS) enzyme activity, … delivery of the VEGF-A gene or protein has been shown to restore erectile function in …

Follistatin

Orphan Drug Status Awarded to New Follistatin Gene Therapy for …

www.gate2biotech.com/orphan-drug-status-awarded-to-new-follistatin-gene-therapy-f…

Dec 20, 2012 – Orphan Drug Status Awarded to New Follistatin Gene Therapy for … Many sufferers oferectile dysfunction in parts of the U.S. are able to buy ..

Effects of the activin A-myostatin-follistatin system on aging bone and …

www.ncbi.nlm.nih.gov › NCBI › Literature › PubMed Central (PMC)

by M Bowser – ‎2013 – ‎Cited by 30 – ‎Related articles

Nov 21, 2012 – Myostatin levels and the myostatin:follistatin ratio increased with age in … loss ofmyostatin function is associated with increased bone density in … (24 months) mice to activin A,follistatin, and myostatin treatment in vitro. ….. cardiac hypertrophy, enhanced cardiac stress response, and sexual dimorphism.

Myostatin genetic inactivation inhibits myogenesis by muscle-derived …

www.ncbi.nlm.nih.gov › NCBI › Literature › PubMed Central (PMC)

by J Tsao – ‎2013 – ‎Cited by 9 – ‎Related articles

Jan 7, 2013 – The genetic inactivation of myostatin in MDSCs was associated with silencing of critical …. Mice were treated according to National Institutes of Health (NIH) ….. Myostatin and follistatin fail to modulate the myogenic differentiation of ….. or muscle-derived stem cells prevent erectile dysfunction in a rat model …

Evaluation of Systemic Follistatin as an Adjuvant to Stimulate Muscle …

www.ncbi.nlm.nih.gov › NCBI › Literature › PubMed Central (PMC)

by JW Foley – ‎2010 – ‎Cited by 13 – ‎Related articles

Jun 15, 2010 – … of striated and smooth muscle, leading to skeletal muscle weakness and … Inhibiting myostatin, a negative regulator of muscle growth, has been … AAV8-follistatin to stimulate muscleregeneration and/or hypertrophy.

Follistatin Improves Skeletal Muscle Healing after Injury and Disease …

www.ncbi.nlm.nih.gov › NCBI › Literature › PubMed Central (PMC)

by J Zhu – ‎2011 – ‎Cited by 47 – ‎Related articles

Recovery from skeletal muscle injury is often incomplete because of the …. action that follistatin has on muscle cell regeneration, angiogenesis, and fibrosis formation. ….. angiogenesis via the activation of endothelial and smooth muscle cells.

Expression and neural control of follistatin versus myostatin genes …

onlinelibrary.wiley.com/doi/10.1002/dvdy.10306/pdf

by AS Armand – ‎2003 – ‎Cited by 40 – ‎Related articles

Follistatin transcripts could be detected in activated satellite cells as early as the first stages of … Key words: follistatin; myostatin; muscle regeneration; denervation. Received 11 July 2002; …… the smooth-to-striated muscle transi- tion. Dev Biol …

Follistatin induction by nitric oxide through cyclic GMP: a tightly …

jcb.rupress.org › 2006 Archive › 16 January

by A Pisconti – ‎2006 – ‎Cited by 106 – ‎Related articles

Jan 9, 2006 – Subsequently, muscle masses undergo extensive growth in the fetal and ….. In smooth muscle, cGMP may act through protein kinase A, …

Stem Cells

Modulation of Stem Cells Differentiation and Myostatin as an approach …

https://www.researchgate.net/…/235087921_Modulation_of_Stem_Cells_Differentiation

We had shown in Years 1 and 2 that the in vitro myogenic differentiation and myotube formation by MDSC was refractory to modulation by myostatinfollistatin, …

Advances in Stem Cell Therapy for Erectile Dysfunction

www.hindawi.com/journals/aandrol/2014/140618/

by CS Lin – ‎2014 – ‎Cited by 2 – ‎Related articles

Jan 20, 2014 – Abstract. Stem cell (SC) therapy for erectile dysfunction (ED) has been investigated in 35 published studies, with one being a small-scale …

International Journal of Impotence Research – Gene and stem cell …

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by W Deng – ‎2005 – ‎Cited by 27 – ‎Related articles

erectile dysfunction, gene therapy, stem cells, endothelial nitric oxide synthase, calcitonin gene-related peptide, superoxide dismutase, RhoA/Rho kinase, …

Stem-cell therapy for erectile dysfunction – ScienceDirect

www.sciencedirect.com/science/article/pii/S2090598X13000880

by M Albersen – ‎2013 – ‎Related articles

Sep 12, 2013 – Erectile dysfunction (ED) is the most common sexual disorder that men report to healthcare providers, and is the male sexual dysfunction that …

Study Shows Liposuction Byproduct Could Lead to ED Cure | Stem …

www.stemcellsportal.com/study-shows-liposuction-byproduct-could-lead-ed-cure

Mar 25, 2015 – The study, conducted in rats, compares the effectiveness of using a byproduct of liposuction — uncultured stromal vascular fraction (SVF) — with adipose-derived stem cells (ADSCs) cultured in the lab to treat ED caused by injury to the cavernous nerve (CN). … However, no study …

Adult stem cell technology holds hope for erectile dysfunction treatment

www.news-medical.net/…/Adult-stemcell-technology-holds-hope-for-erectiledysfun

Sep 10, 2012 – After more than a decade of short-term cures to erectile dysfunction, most aimed at symptoms rather than the underlying issues of nerve …

Stem Cell Therapy for Erectile Dysfunction: A Critical Review (PDF …

https://www.researchgate.net/…/51525332_Stem_Cell_Therapy_for_Erectile_Dysfunc

dysfunction; nNOS, neuronal. nitric oxide synthase. STEM CELL THERAPY FOR ERECTILE DYSFUNCTION 345. Page 3. Table 1Erectile Dysfunction-Related …

Missing: tropoelastin

[PDF]

Adipose-derived Stem Cells for the Treatment of Peyronie’s Disease?

www.europeanurology.com/…/adipose-derived-stemcells-for-the-treatment-of-peyro…

by CS Lin – ‎2013 – ‎Cited by 10 – ‎Related articles

Adipose-derived Stem Cells for the Treatment of Peyronie’s … evident in the erectile dysfunction(ED) field. … As for elastin, its upregulation by TGF-b in TA-.

Stem cell therapy for erectile dysfunction

www.wjgnet.com/2219-2816/full/v3/i3/272.htm

by E Suzuki – ‎2014 – ‎Related articles

Nov 24, 2014 – Erectile dysfunction (ED) is an importa

Stem cell therapy for voiding and erectile dysfunction

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by M Vaegler – ‎2012 – ‎Cited by 19 – ‎Related articles

Jun 19, 2012 – Stem cell therapy for voiding and erectile dysfunction …. Homing cytokines, such as stromal derived factor-1 (SDF1), have been shown to ..

IGF-1

Insulin-like growth factor-1 restores erectile function in aged rats – NCBI

www.ncbi.nlm.nih.gov/pubmed/18355170

by XY Pu – ‎2008 – ‎Cited by 49 – ‎Related articles

Mar 19, 2008 – INTRODUCTION: Insulin-like growth factor-1 (IGF1) is one of the growth factors … that gene transfer of IGF1 to the penis could improve erectile capacity. … Stimulation; Erectile Dysfunction/drug therapy*; Erectile Dysfunction

Emerging gene and stem cell therapies for the treatment of erectile …

www.ncbi.nlm.nih.gov › NCBI › Literature › PubMed Central (PMC)

by A Harraz – ‎2010 – ‎Cited by 21 – ‎Related articles

Feb 16, 2010 – Stem cell therapy has been a topic of interest in more recent years although … Erectile dysfunction (ED) is the persistent inability to achieve or maintain an …. Cavernosal gene transfer ofIGF1 using an adenoviral vector in …

IGF1 Levels Are Significantly Correlated With Sexual Function …

thinksteroids.com › Forums › Medicine › Men’s Health Forum

Sep 17, 2011 – 15 posts – ‎8 authors

An association between low GH levels and erectile dysfunction has been … Given that the half-life ofIGF1 (12–15 h) is significantly longer than …

SDF-1

Recruiting endogenous stem cells: a novel therapeutic approach for …

www.ajandrology.com/article.asp?issn=1008-682X;year=2016;volume…

by ZC Xin – ‎2016 – ‎Cited by 2 – ‎Related articles

Transplanted stem cells (SCs), owing to their regenerative capacity, represent one of the most promising methods to restore erectile dysfunction (ED). However …

[PDF]

Low-energy Shock Wave Therapy Ameliorates Erectile Dysfunction in …

www.jsm.jsexmed.org/article/S1743-6095(15)00013-2/pdf

Results: LESW treatment improves erectile function in a rat model of pelvic neurovascular ….. betic EDmodel,11 and that the expression of SDF1, which plays.

SDF1 Gene Variation Is Associated with Circulating SDF1α Level and …

paperity.org/…/sdf1-gene-variation-is-associated-with-circulating-sdf1a-level-and-end…

There was an association between the SDF1 gene rs2297630 SNP A/A genotype, … peripheral vascular disease[10] and patients with erectile dysfunction[16].

HGF

Hepatocyte growth factor-modified adipose tissue-derived stem … – NCBI

www.ncbi.nlm.nih.gov/pubmed/26339935

by T Liu – ‎2015 – ‎Cited by 1 – ‎Related articles

Sep 4, 2015 – Hepatocyte growth factor-modified adipose tissue-derived stem cells improve erectile function in streptozotocin-induced diabetic rats. Liu T(1) …

mp89-03 local delivery of recombinant human hepatocyte growth …

www.jurology.com/article/S0022-5347(16)02752-X/abstract

MP89-03 LOCAL DELIVERY OF RECOMBINANT HUMAN HEPATOCYTE GROWTH FACTORPROTEIN RESCUES ERECTILE FUNCTION BY ENHANCING …

Innovative trends and perspectives for erectile dysfunction treatment: A …

www.sciencedirect.com/science/article/pii/S2090598X16300092

by EA Ismail – ‎2016

May 18, 2016 – This projection indicates a growing need to re-evaluate ED ….. (2015) [38] found that treatment with hepatocyte growth factor-modified ADSCs …

Activin

Activin Receptor-Like Kinase 5 Inhibitor Attenuates Fibrosis in … – NCBI

www.ncbi.nlm.nih.gov › NCBI › Literature › PubMed Central (PMC)

by JH Jang – ‎2012 – ‎Cited by 9 – ‎Related articles

Jan 25, 2012 – Activin Receptor-Like Kinase 5 Inhibitor Attenuates Fibrosis in ….. Mulhall JP, Creech SD, Boorjian SA, Ghaly S, Kim ED, Moty A, et al.

eNOS and VEGF

Endothelial Dysfunction in Erectile Dysfunction: Role of the …

onlinelibrary.wiley.com › … › Journal of Andrology › Vol 24 Issue S6 › Abstract

by TJ Bivalacqua – ‎2003 – ‎Cited by 191 – ‎Related articles

Jan 2, 2013 – eNOS -/- mice demonstrate normal erectile fu

Age-related changes in phosphorylation of endothelial nitric oxide …

www.ncbi.nlm.nih.gov/pubmed/16422866

by B Musicki – ‎2005 – ‎Cited by 67 – ‎Related articles

AIM: Aging is associated with erectile dysfunction (ED) attributed to reduced … factor (VEGF) exerts erectile effects and operates via eNOS phosphorylation in …

Endothelial nitric oxide synthase gene therapy for erectile dysfunction.

www.ncbi.nlm.nih.gov/pubmed/16378511

by TJ Bivalacqua – ‎2005 – ‎Cited by 27 – ‎Related articles

Curr Pharm Des. 2005;11(31):4059-67. Endothelial nitric oxide synthase gene therapy for erectile dysfunction. Bivalacqua TJ(1), Musicki B, Usta MF, Champion …

Vascular endothelial growth factor restores erectile function through …

www.ncbi.nlm.nih.gov/pubmed/15592104

by M Yamanaka – ‎2005 – ‎Cited by 61 – ‎Related articles

J Urol. 2005 Jan;173(1):318-23. Vascular endothelial growth factor restores erectile functionthrough inhibition of apoptosis in diabetic rat penile crura.

Tropoelastin

Erectile dysfunction in the type II diabetic db/db mouse: impaired …

www.ncbi.nlm.nih.gov/pubmed/18326798

by IP Luttrell – ‎2008 – ‎Cited by 35 – ‎Related articles

Mar 7, 2008 – Erectile dysfunction in the type II diabetic db/db mouse: impaired … mRNA levels fortropoelastin, fibrillin-1, and alpha1(I) collagen were …

Disorganization of Elastin Matrix Mediates Erectile Dysfunction …

https://iths.pure.elsevier.com/…/disorganization-of-elastin-matrix-mediates-erectiledy

DESCRIPTION (provided by applicant): The outer layer of the corpus cavernosum, the tunica albuginea, is rich in elastic fibers and has the capacity to expand in …

Bioelectrical Stimulation + Stem Cell Composition Mix for Erectile Dysfunction

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 

Sponsor:

MyoStim ED a Leonhardt Ventures Co. 

Collaborator:

Harbor UCLA LABioMed

Information provided by (Responsible Party):

Howard Leonhardt, Executive Chairman MyoStim ED Leonhardt Ventures 

ClinicalTrials.gov Identifier:

First received:  TBD

Last updated: TBD

Last verified:  July 2016

  • Full Text View

  Purpose

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.

Condition

Intervention

Phase

Erectile Dysfunction

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

Phase 2

Study Type:

Interventional

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:

30

Study Start Date:

TBD

Estimated Study Completion Date:

May 2018

Estimated Primary Completion Date:

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

Arms

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

  Eligibility

Ages Eligible for Study:  

40 Years to 70 Years   (Adult, Senior)

Genders Eligible for Study:  

Male

Accepts Healthy Volunteers:  

No

Criteria

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 ClinicalTrials.gov identifier: =

Contacts

Locations

Sponsors and Collaborators

MyoStim ED Leonhardt Ventures

Harbor UCLA LABIOMED

Investigators

Study Director:  TBD 

  More Information

Responsible Party:

TBD 

ClinicalTrials.gov Identifier:

Other Study ID Numbers:

Study First Received:

TBD 

Last Updated:

TBD 

Health Authority:

TBD 

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

ClinicalTrials.gov processed this record **** TBD