Scientific Related Articles
See the below studies which highlight the potential role of myostatin follistatin balance in erectile dysfunction recovery.
Related Articles
Predictors of Sexual Desire and Sexual Function in Sedentary Middle-Aged Adults: The Role of Lean Mass Index and S-Klotho Plasma Levels. The FIT-AGEING Study – Click Here
The Use of Bioelectrical Stimulation in the Treatment of Erectile Dysfunction – Click Here
Sonic hedgehog regulation of cavernous nerve regeneration – Click Here
Highlights
•SHH protein is more effective in promoting neurite formation/CN regeneration in aged rats than in the adult.
•The first 48 h after CN injury are a critical window when growth factors are released, that impact later neurite formation.
•SHH pathway signaling machinery remains intact in aged MPG/CN and are able to respond to exogenous SHH protein.
•These studies are significant because the aged prostatectomy model will more accurately simulate ED patient response.
•Understanding how neurite formation changes with age is critical for clinical translation of SHH PA to prostatectomy patients
The Use of Bioelectrical Stimulation in the Treatment of Erectile Dysfunction – Click Here
Radial Pressure Pulse Therapy a Complementary Adjunctive Technology to MyoStim ED ErectiStim and ErectiStim Plus Biologics Therapies – Click Here
Electrical stimulation promotes the angiogenic potential of adipose-derived stem cells – Click Here
Optimal electrical stimulation boosts stem cell therapy in nerve regeneration – Click Here
Altered Sonic Hedgehog Signaling Is Associated with Morphological Abnormalities in the Penis of the BB/WOR Diabetic Rat1 – Click Here
Predictors of Sexual Desire and Sexual Function in Sedentary Middle-Aged Adults: The Role of Lean Mass Index and S-Klotho Plasma Levels. The FIT-AGEING Study April 2020Volume 17, Issue 4, Pages 665–677 – Click Here
Effects of Functional Electrostimulation on Erectile Function Recovery
Myostatin, a profibrotic factor and the main inhibitor of striated muscle …
Low-energy Shock Wave Therapy Ameliorates Erectile Dysfunction in …
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 myostatin, follistatin, …
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 …
www.nature.com › Journal home › Archive › Reviews
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-stem–cell-technology-holds-hope-for-erectile–dysfun…
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 1. Erectile Dysfunction-Related …
Missing: tropoelastin
[PDF]
Adipose-derived Stem Cells for the Treatment of Peyronie’s Disease?
www.europeanurology.com/…/adipose-derived-stem–cells-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
www.ncbi.nlm.nih.gov › NCBI › Literature › PubMed Central (PMC)
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 (SDF–1), 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 (IGF–1) is one of the growth factors … that gene transfer of IGF–1 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 ofIGF–1 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 ofIGF–1 (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 SDF–1, 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-erectile–dy…
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 …
This trial showed that Functional Electrical Stimulation therapy may improve erectile function and quality of life in men with ED.
An initial study on the effect of functional electrical stimulation in …
May 22, 2018 – Functional electrical stimulation (FES) therapy has shown a high regenerative … and increased mental stress, making ED a major quality of life (QoL) issue [2]. … multiple sclerosis, prostatectomy); hypogonadism (total testosterone < 300 ….. Nature asia · Nature China · Nature India · Nature Japan · Nature .
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.
|
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
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) |
|
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
Erectile function restored with cell therapy in preclinical model
https://bjui-journals.onlinelibrary.wiley.com/doi/abs/10.1111/bju.14631
Although each stem cell population has been separately evaluated in various short (two weeks) or middle-term (four to six weeks) preclinical in vivo experiments, one important question should be addressed: whether each stem cell population from different sources achieves similar outcomes for recovery in a severe erectile dysfunction model after long-term follow-up.
In this study, researchers at the Wake Forest Institute for Regenerative Medicine tested the therapeutic impact of three cell types – amniotic fluid-derived stem cells, umbilical vein endothelial cells and adipose-derived stem cells — to determine the long-term therapeutic effect on erectile function recovery in a rat model of dual neurovascular-injury erectile dysfunction. The cells were injected intracavernously into the penile tissue. Saline injection served as a control group. Erectile function and analyses of penile tissues were assessed 12 weeks later.
All three cell treatment groups showed a significant improvement in erectile function, as compared to the saline-injected control group. However, the amniotic fluid-derived stem cells had a better recovery potential.
The researchers concluded that the long-term therapeutic effect achieved promising outcomes in restoring erectile function and improving neuromuscular regeneration and endothelial repair in vivo, which may provide an alternative approach to the treatment of patients with ED after radical prostatectomy or severe pelvic neurovascular injury.
https://doi.org/10.1111/bju.14631