Erectile Dysfunction

     Erectile Dysfunction (ED) is defined as the inability to achieve or sustain an erection suitable for sexual intercourse. ED affects up to one third of men of men throughout their lives and has a substantial negative impact on intimate relationships, quality of life and self-esteem. Causes are multifactorial but can be related to loss of testosterone, surgical damage to the penile nerves, medications, or other medical illnesses. The most common cause of ED is “vasculopathy”, which is damage to the delicate blood vessels in the penis. This vasculopathy is often associated with age but strongly related to atherosclerosis, diabetes, hypertension, high cholesterol and cerebrovascular and peripheral vascular disease.  Vasculopathy is also very prominent in patients with Peyronies disease and penile scarring. Men with ED are also at significantly increased risk of coronary artery disease. Therefore, when men have ED, screening for cardiovascular risk factors should be considered because symptoms of ED present as much as three years earlier than other symptoms of coronary artery disease such as chest pain. The current treatment of ED centers around the use of Phosphodiesterase type 5 inhibitors such as Viagra, Cialis, or Levitra. Intraurethral pellets and intracavernosal (penile injectable agents) are also available if oral medications fail. Various mechanical external vacuum pump devices are helpful also in patients who are comfortable with assisted devices. Penile revascularization surgery has mostly fallen out of favor due to poor outcomes in most patients. At this time, the only treatment available to patients who have not succeeded with any of the above are surgically implanted hydraulic penile prostheses. These surgeries are somewhat invasive but often effective.

     Adipose derived stem cells have shown extraordinary promise in revascularizing cardiac tissue, ischemic limbs and other organs suffering damage from poor blood flow by regenerating small blood vessels as well as smooth muscle and nerves. We have evidence that adipose derived stem cells stimulate endothelial (small blood vessel lining) growth and improve penile blood flow in animal models. Early attempts have been made in human patients to improve erectile function using adult mesenchymal stem cells however results have been inconsistent. There is some evidence that results will be optimized if the transplanted stem cells are “activated.” The process of stem cell activation is usually a natural phenomenon  induced by inflammatory and ischemic events. However, chronic micro-vasculopathy may require tissue micro-trauma to induce cellular healing and angiogenesis. Controlled tissue micro-trauma can be induced using low intensity shock wave treatment of the penis has been used successfully for years for penile pain associated with Peyronies disease. In 2012, a publication in the Journal of Urology (See Citation) provided evidence that shock wave technology alone can significantly improve erectile function in comparison to placebo treatment.

The Journal of Urology Volume 187, Issue 4, Supplement , Page e606, April 2012


We use a protocol to deploy extremely high numbers of adipose derived stromal vascular fraction (rich in stem cells and growth factors) into the penile corpora cavernosa in conjunction with low intensity shock wave therapy in an effort to stimulate vascular endothelial repair and angiogenesis. This represents an attempt to achieve improvement erectile dysfunction in patients with vasculopathy and Peyronies disease.

We care about our Erectile Disfunction patients and take pride in the time we provide to our patients to deploy the best protocols to help our patients achieve their goals. By filling out Candidate Application, we will answer the questions and concerns you may have about our protocols for Erectile Disfunction.


Cell Surgical Network Study for Stromal Vascular Fraction Registered by

Rancho Mirage, CA (PRWEB) October 14, 2013, a service of the U.S. National Institutes of Health has registered on their public site an IRB approved safety study from the Cell Surgical Network, Inc.. This study is available for patients with various degenerative and inflammatory conditions to undergo Stromal Vascular Fraction deployment for the evaluation and for the advancement of future stem cell therapy procedures. Stromal Vascular Fraction is rich in autologous adipose derived stem cells and growth factors.

Stromal Vascular Fraction (SVF) is obtained by lipo-harvesting, procurement, and lipo-transfer as a same day operative procedure to provide therapy to patients with various degenerative and inflammatory diseases. Patients must be 16 years or older, male or female and have a degenerative disease or inflammatory disease that meets criteria for treatment under the IRB which includes: Arthritis, Auto-immune disease, COPD, Cardiomyopathy, Peyronies Disease, Interstitial Cystitis, Erectile Dysfunction, and Neurodegenerative disease such as Parkinson’s, ALS, Neuropathy. Patients must be healthy enough to tolerate a local anesthetic, must not have active cancer or infections.

Dr. Elliot Lander, and Dr. Mark Berman, founders of the Cell Surgical Network Inc. will conduct the study: “Ever since our inception, it’s been our goal to maintain transparency during our investigations. With a closed surgical procedure we can provide effective safety studies and evolve good empirical data that will allow us and others to ultimately refine our protocols,” says Dr. Berman.

The purpose of the safety study is to evaluate for any adverse effects that may be related to the administration and reception of autologous adipose derived stromal vascular fraction (SVF). Secondarily, the study monitors the results of subjective and objective findings as it applies to the non-blinded deployment of autologous SVF for various inflammatory and/or degenerative conditions including select orthopedic, neurologic, urologic and cardio-pulmonary conditions. SVF deployments include intra-venous, intra-articular, and soft tissue injections.

Outcome measures will include the number of participants with adverse events related to either SVF deployment or the lipo-harvesting procedure. Interested patients should contact the treatment center by phone: 800-231-0407 or via email: info(at)cellsurgicalnetwork(dot)com

About Cell Surgical Network:

The affiliates of the Cell Surgical Network (CSN) are devoted to advancing access and quality care in the area of adult stem cell regenerative medicine in order to help people suffering from a variety of inflammatory and degenerative conditions. The Cell Surgical Network was founded nearly two years after the formation of the California Stem Cell Treatment Center (founded in 2010). Affiliate members are generally made up of multi-state and international teams of multidisciplinary physicians in order to best assess and provide care for our patients. The Cell Surgical Network emphasizes quality and is highly committed to clinical research and the advancement of regenerative medicine.

Erectile dysfunction: Stem cell therapy restores sexual function in phase I trial
published Saturday 25 March 2017

     Early results of a clinical trial suggest that stem cell therapy may be a promising treatment for erectile dysfunction, after the procedure was found to restore sexual function in men with the condition. The stem cell therapy involves injecting the patients' own stem cells - derived from abdominal fat cells - into the erectile tissue of the penis.
     Lead researcher Dr. Martha Haahr, of Odense University Hospital in Denmark, and colleagues found that within 6 months of the procedure, 8 of the 21 men treated were able to engage in spontaneous sexual intercourse.
     The researchers recently presented their findings at EAU17 - the European Association of Urology's annual conference - held in London in the United Kingdom.
     Erectile dysfunction (ED) is a condition whereby a man has difficulties getting or maintaining an erection in order to engage in sexual intercourse. According to the National Institute of Diabetes and Digestive Kidney Diseases, around 12 percent of men under the age of 60, and 22 percent of men aged between 60 and 69, have ED. High blood pressure, diabetes, heart disease, chronic kidney disease, and prostate surgery are some of the physical conditions that can cause ED. Psychological issues - such as anxiety, stress, depression, and low self-esteem - can also contribute to ED. Current treatments for ED include PDE5 inhibitors (such as Viagra), penile implants, and injections. However, Dr. Haahr and team note that all of these therapies can have significant side effects. As a result, researchers are on the hunt for alternative treatments for ED, and stem cell therapy has emerged as a promising candidate in animal trials.

          Sexual function improvements evident a year after treatment
     In their phase I trial, Dr. Haahr and colleagues tested stem cell therapy on 21 men who had ED as a result of undergoing radical prostatectomy for prostate cancer. None of the men had responded to standard medical treatment for ED.
For the stem cell procedure, abdominal fat cells were extracted from each man through liposuction. Stem cells were then isolated from the fat cells and injected into the corpus cavernosum of the penis - the spongy tissue that normally becomes filled with blood during an erection.
     Before the stem cell procedure and 6 and 12 months after, the participants' erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire. An IIEF score of 5-7 represents severe erectile dysfunction, 12-16 is mild to moderate erectile dysfunction, and 22-25 is no erectile dysfunction.
All 21 men saw their erectile function improve with stem cell therapy: their IIEF score increased from 6 prior to treatment to 12 at 6 months after treatment.
     Eight of the men reported that they had been able to engage in spontaneous sexual activity 6 months after stem cell therapy, and this outcome remained evident at 12 months after treatment. These men saw their IIEF score rise from 7 to 14 with stem cell therapy.
      "What we have done establishes that this technique can lead to men recovering a spontaneous erection - in other words, without the use of other medicines, injections, or implants," says Dr. Haahr.

         Stem cell therapy 'could be a long-term solution' for ED
    Although the study findings are preliminary, the team says that they show promise for stem cell therapy as an effective treatment strategy for ED.
     "We are the first to use a man's own fat stem cells as a treatment for erectile dysfunction in a clinical trial. The technique has been trialed in animal work, but this is the first time stem cell therapy has allowed patients to recover sufficient erectile function to enable intercourse," says Dr. Haahr.
     "We are pleased with the preliminary outcomes, especially as these men had previously seen no effect from traditional medical treatment and continue to have good erectile function after 12 months follow-up, indicating that this might be a long-term solution.
 This suggests the possibility of therapeutic options for patients suffering from erectile dysfunction from other causes. But we need to remember that this is a small trial, with no control group. We're still some time away from a clinically available solution."-Dr. Martha Haahr

The researchers are now in the process of initiating a phase II trial to further investigate the safety and efficacy of stem cell therapy for ED.

Stem cells shown to restore erection capability in men with erectile dysfunction.

European Association of Urology
22 March 2017

New clinical trial results show that stem cells can restore sufficient erectile function to allow previously impotent men to have spontaneous intercourse. This is the first time stem cell therapy has produced patients who have recovered sufficient erectile function to enable intercourse. This is an early trial, which was primarily addressing safety and dosage (a Phase 1 trial), so the results need to be interpreted accordingly.
In recent years several groups have worked to develop stem cell therapy as a cure for erectile dysfunction, but until now the improvements have not been sufficient to allow affected men to achieve full sexual intercourse. Results presented at the European Association of Urology conference in London show that 8 out of 21 have successfully regained sexual function.

Lead researcher, Dr Martha Haahr (Odense University Hospital) said “What we have done establishes that this technique can lead to men recovering a spontaneous erection – in other words, without the use of other medicines, injections, or implants. We are now beginning a larger Phase 2 trial to better evaluate its effectiveness and confirm its safety”.

Erectile dysfunction affects nearly half of men between the ages of 40 and 70 to some degree. There are several possible causes, including surgery (e.g. prostate surgery), high blood pressure, diabetes, cardiovascular disease and psychological problems. Current remedies, which include medications such as PDE5 inhibitors (such as Viagra and Cialis), injections, or penile implants; all have some disadvantages, so scientists have been searching to find a way which restores natural sexual function. The present work focuses on patients with physical damage, caused by surgery (radical prostatectomy) for prostate cancer.

The research group, from Odense in Denmark, used stem cells taken from abdominal fat cells via liposuction (under a general anaesthetic): none of the 21 men reported significant side effects over the trial period, or in the following year. After isolating the stem cells, they were injected into the corpus cavernosum area of the penis. The patients were able to be discharged the same day.

Within 6 months of the treatment, 8 out of the 21 patients reported that they had recovered sufficient erectile function to achieve penetrative) sexual activity. This improvement has been maintained for a year, indicating that this treatment may confer long-term benefits. Only those men who were continent were reported to have recovered sexual function (incontinence is also one of the risks of radical prostatectomy prostate surgery).

Using the generally-accepted IIEF questionnaire to measure erectile function, the whole group of 21 patients reported that their score had increased from 6 before the stem cell transplantation surgery, to 12 after 6 months.  However, in the group of men who recovered sexual function, the IIEF score increased from 7 to 14 (the average in men with ‘normal’ sexual function is around 25). This is enough to enable some of the continent men to have a spontaneous erection sufficient for penetrative sex, others achieved this with the help of medication.

Dr Martha Haahr said:

“We are the first to use a man’s own fat stem cells as a treatment for erectile dysfunction in a clinical trial. The technique has been trialed in animal work, but this is the first time stem cell therapy has allowed patients to recover sufficient erectile function to enable intercourse.

We are pleased with the preliminary outcomes, especially as these men had previously seen no effect from traditional medical treatment and continue to have good erectile function after 12 months follow-up, indicating that this might be a long-term solution. This suggests the possibility of therapeutic options for patients suffering from erectile dysfunction from other causes. But we need to remember that this is a small trial, with no control group. We’re still some time away from a clinically available solution”.

Commenting Professor Jens Sønksen (Herlev, Denmark), member of the EAU Scientific Congress Committee, said

“This is interesting and novel research looking into the future. The study by Haahr and co-workers is preliminary and more research is needed on the topic. But there is no doubt that stem cell therapy will become an important tool in the treatment of erectile dysfunction. ”

Treating ED With Stem Cells

6 Suppl 3:320-7
Potential of adipose-derived stem cells for treatment of erectile dysfunction.
Lin G, Banie L, Ning H, Bella AJ, Lin CS, Lue TF.

Adipose-derived stem cells (ADSCs) are a somatic stem cell population contained in fat tissue that possess the ability for self-renewal, differentiation into one or more phenotypes, and functional regeneration of damaged tissue, which may benefit the recovery of erectile function by using a stem cell-based therapy. AIM: To review available evidence concerning ADSCs availability, differentiation into functional cells, and the potential of these cells for the treatment of erectile dysfunction (ED).

METHODS: We examined the current data (from 1964 to 2008) associated with the definition, characterization, differentiation, and application of ADSCs, as well as other kinds of stem cells for the cell-based therapies of ED.

MAIN OUTCOME MEASURES: There is strong evidence supporting the concept that ADSCs may be a potential stem cell therapy source in treating ED.

RESULTS: The ADSCs are paravascularly localized in the adipose tissue. Under specific induction medium conditions, these cells differentiated into neuron-like cells, smooth muscle cells, and endothelium in vitro. The insulin-like growth factor/insulin-like growth factor receptor (IGF/IGFR) pathway participates in neuronal differentiation while the fibroblast growth factor 2 (FGF2) pathway is involved in endothelium differentiation. In a preliminary in vivo experiment, the ADSCs functionally recovered the damaged erectile function. However, the underlying mechanism needs to be further examined.

CONCLUSION: The ADSCs are a potential source for stem cell-based therapies, which imply the possibility of an effective clinical therapy for ED in the near future.

PMID: 19267855 [PubMed – indexed for MEDLINE]

Cell Based Therapy For ED

Stem and endothelial progenitor cells in erection biology.
Strong TD, Gebska MA, Champion HC, Burnett AL, Bivalacqua TJ.

Erectile dysfunction (ED) is defined as the consistent inability to obtain or maintain an erection forsatisfactory sexual relations. The past 20 years of basic science research on erection physiology has been devoted to investigating the pathogenesis of ED and has led to the conclusion that ED is predominately a disease of vascular origin with dramatic changes occurring in the endothelium. Research has also led to an understanding of the biochemical factors and intracellular mechanisms responsible for corporal smooth muscle contraction and relaxation and the influence of endothelium-derived relaxing factors. The development of methods to deliver both stem and endothelial cells to the penis has kindled a keen interest in treating ED with gene- and cell-based therapies. In this paper, erection physiology and stem cell biology is reviewed, and the potential application of novel cell-based therapies for the treatment of ED is discussed.

PMID: 18256677 [PubMed – indexed for MEDLINE]

Andrology-Related Stem Cell

Recent advances in andrology-related stem cell research.
Lin CS, Xin ZC, Deng CH, Ning H, Lin G, Lue TF

Stem cells hold great promise for regenerative medicine because of their ability to self-renew and to differentiate into various cell types. Although embryonic stem cells (BSC) have greater differentiation potential than adult stem cells, the former is lagging in reaching clinical applications because of ethical concerns and governmental restrictions. Bone marrow stem cells (BMSC) are the best-studied adult stem cells (ASC) and have the potential to treat a wide variety of diseases, including erectile dysfunction (ED) and male infertility. More recently discovered adipose tissue derived stem cells (ADSC) are virtually identical to bone marrow stem cells in differentiation and therapeutic potential, but are easier and safer to obtain, can be harvested in larger quantities, and have the associated benefit of reducing obesity. Therefore, ADSC appear to be a better choice for future clinical applications. We have previously shown that ESC could restore the erectile function of neurogenic ED in rats, and we now have evidence that ADSC could do so as well. We are also investigating whether ADSC can differentiate into Leydig, Sertoli and male germ cells. The eventual goal is to use ADSC to treat male infertility and testosterone deficiency.

PMID: 18286209 [PubMed – indexed for MEDLINE]

Stem cell therapies for the treatment of erectile dysfunction

Nat Rev Urol. 2010 Mar; 7(3) : 143-52
Emerging gene and stem cell therapies for the treatment of erectile dysfunction.

Harraz A, Shindel AW, Lue TF

Erectile dysfunction is a prevalent condition that leads to significant morbidity and distress, not just for affected men but also for their partners. Very few currently available treatments ameliorate the underlying causes of the disorder and ‘cure’ the disease state. Much recent effort has been focused on the development of gene and cell-based approaches to rectify the molecular and tissue defects responsible for ED. Gene therapy has been investigated in animal models as a means to restore normal function to the penis; at this time, however, only one human trial has been published in the peer-reviewed literature. Recent gene therapy studies have focused on the modulation of enzymes associated with the NOS/cGMP pathway, and supplementation of trophic factors, peptides and potassium channels. Stem cell therapy has been a topic of interest in more recent years but there are currently very few published reports in animal models and none in human men. Although stem cell therapy offers the potential for restoration of functional tissues, legitimate concerns remain regarding the long-term fate of stem cells. The long-term safety of both gene and stem cell therapy must be thoroughly investigated before large-scale human studies can be considered.

PMID: 20157303 [PubMed – in process]

Advance of neurogenic erectile dysfunction therapy by stem cells.

Fa Yi Xue Za Zhi. 2010 Jun; 26(3) : 206-9.
Advance of neurogenic erectile dysfunction therapy by stem cells.

Shen HJ, Zhu GY.

Neurogenic erectile dysfunction (NED) commonly results from erectile nerve damage. Recent targeted at repairing and protecting nervi erigentes. In this paper, researches of NESCs, MDSCs, ASCs and MSCs in NED are reviewed. Early studies have demonstrated that stem cells and gene modified stem cells were effective to the therapy of ED, even likely to cure ED. Stem cells are expected to be applied in the clinical therapy of NED. Stem cells as a new therapy technique will bring up a new challenge in forensic clinical medicine.

PMID: 20707282 [PubMed]

Hyperlipidemia associated erectile dysfunction.

J Sex Med. 2010 Apr; 7(4 Pt 1) : 1391-400
The effect of intracavernous injection of adipose tissue-derived stem cells on hyperlipidemia associated erectile dysfunction in a rat model.

Huang YC, Ning H, Shindel AW, Fandel TM, Lin G, Harraz AM, Lue TF, Lin CS.

Hyperlipidemia has been associated with erectile dysfunction (ED) via damage to the cavernous endothelium and nerves. Adipose tissue-derived stem cells (ADSC) have been shown to differentiate into endothelial cells and secrete vasculotrophic and neurotrophic factors. AIM: To assess whether ADSC have therapeutic effects on hyperlipidemia-associated ED. METHODS: Twenty-eight male rats were induced to develop hyperlipidemia with a high-fat diet (hyperlipidemic rats, HR). Ten additional male rats were fed a normal diet to serve as controls (normal rats, NR). Five months later, all rats were subjected to ADSC isolation from paragonadal fat. The cells were cultured for 1 week, labeled with 5-ethynyl-2′-deoxyuridine (EdU), and then injected autologously into the corpus cavernosum of 18 HR. The remaining 10 HR rats were injected with phosphate buffered saline (PBS). At 2 and 14 days post-transplantation, four rats in the HR + ADSC group were sacrificed for tracking of the transplanted cells. At 28 days post-transplantation, all remaining rats were analyzed for serum biochemistry, erectile function, and penile histology. MAIN OUTCOME MEASURES: Erectile function was assessed by intracavernous pressure (ICP) measurement during electrostimulation of the cavernous nerve. Cavernous nerves, endothelium, and smooth muscle were assessed by immunohistochemistry. RESULTS: Serum total cholesterol and low-density lipoprotein levels were significantly higher in HR than in NR. High-density lipoprotein level was significantly lower in HR than in NR. Mean ICP/mean arterial pressure ratio was significantly lower in HR + PBS than in NR + PBS or HR + ADSC. Neuronal nitric oxide synthase (nNOS)-positive nerve fibers and endothelial cells were fewer in HR + PBS than in HR + ADSC. Smooth muscle content was significantly higher in both HR groups than in NR. CONCLUSIONS: Hyperlipidemia is associated with abnormalities in both the nerves and endothelium. Treatment with ADSC ameliorates these adverse effects and holds promise as a potential new therapy for ED.

PMID: 20141586 [PubMed – indexed for MEDLINE]

Tissue engineering for the lower urinary tract: a review of a state of the art approach.

Eur Urol. 2007 Dec;52(6):1580-9

Sievert KD, Amend B, Stenzl A



OBJECTIVES: Tissue engineering (TE) has become synonymous with physiological and functional reconstructive approaches in medicine. Although the goals of TE are ambitious and have not yet been attained, significant milestones have been achieved and future possibilities are great. To examine these possibilities with a special emphasis on the lower urinary tract, we provide a review of the development of TE techniques and a high-level overview of related regulatory and legal issues.

METHODS: Current trends in the field of TE, including the use of stem cells, scaffold optimization, and acellular tissue and growth factors, were reviewed and critically assessed through a comprehensive literature review using the PubMed database. Because of the rapid development of new TE approaches, recent abstracts from international urology conventions were included. A review of 2007 European Medicines Agency and Commission for Advanced Therapies legal regulations was also performed.

RESULTS: Although several clinical TE approaches have been developed, most lack objective validation. A variety of TE techniques are currently under development or investigation, but thus far, no one approach is clearly superior on the basis of significant long-term studies. A medical product based on TE and stem cells can be successfully developed only with careful consideration of legal and ethical regulations.

CONCLUSIONS: TE holds the promise for a tremendous impact on reconstructive urology. However, research must be focused and intensified for the full potential clinical benefits to be made widely available. Because the product development is affected by legal regulations, consensus must be achieved.

PMID: 17889986 [PubMed – indexed for MEDLINE]

Preclinical evidence for the benefits of penile rehabilitation therapy following nerve-sparing radical prostatectomy.

Adv Urol. 2008:594868

Preclinical evidence for the benefits of penile rehabilitation therapy following nerve-sparing radical prostatectomy.

Albersen M, Joniau S, Claes H, Van Poppel H


Erectile dysfunction following radical prostatectomy remains a frequent problem despite the development of nerve-sparing techniques. This erectile dysfunction is believed to be neurogenic, enhanced by hypoxia-induced structural changes which result in additional veno-occlusive dysfunction. Recently, daily use of intracavernous vasoactive substances and oral use of PDE5-inhibitors have been clinically studied for treatment of postprostatectomy erectile dysfunction. Since these studies showed benefits of “penile rehabilitation therapy,” these effects have been studied in a preclinical setting. We reviewed experimental literature on erectile tissue preserving and neuroregenerative treatment strategies, and found that preservation of the erectile tissue by the use of intracavernous nitric oxide donors or vasoactive substances, oral PDE5-inhibitors, and hyperbaric oxygen therapy improved erectile function by antifibrotic effects and preservation of smooth muscle. Furthermore, neuroregenerative strategies using neuroimmunophilin ligands, neurotrophins, growth factors, and stem cell therapy show improved erectile function by preservation of NOS-containing nerve fibers.

PMID: 18604295 [PubMed]

Progress in researches on stem cell therapy for erectile dysfunction.

Zhonghua Nan Ke Xue. 2009 Oct;15(10):937-40

Progress in researches on stem cell therapy for erectile dysfunction.

Jiang YB, Gou X:


Erectile dysfunction (ED) commonly results from endothelial dysfunction and erectile nerve damage. Recent researches have focused on the preclinical studies of stem cell-based therapies targeted at repairing penile endothelium and protecting erectile nerves. Early studies showed that stem cell- or gene-modified stem cell-based therapies may have enduring efficacy and eventually lead to a cure for ED. Such stem cells as embryonic, mesenchymal, muscle-derived and adipose-derived ones and endothelial progenitor cells all have differentiation potentials and obvious advantages in protecting and repairing both nervi erigentes and corpus cavernosum vascular endothelial cells. Stem cell-based therapies promise to be an effective approach to human erectile dysfunction.

PMID: 20112746 [PubMed – indexed for MEDLINE]

Prospects for application of stem cells from adipose tissue in treating erectile dysfunction.

Urologiia. 2015 Dec;(6):98-103.

Authors: Chaliy ME, Glybochko PV, Epifanova MV, Krasnov AO.

Although phosphodiesterase type 5 inhibitors are the first-line treatment of ED, some patients remain unresponsive to any pharmacotherapy. To date, the use of stem cells is considered as a new treatment modality for erectile dysfunction. The validity of this assumption has been experimentally proved in preclinical and clinical studies. The main focus is on the stem cells derived from adipose tissue, due to advantages over other sources.



Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: An Open-Label Phase I Clinical Trial.

 EBioMedicine. 2016 Jan 19;5:204-10. doi: 10.1016/j.ebiom.2016.01.024. eCollection 2016 Mar.

Authors: Haahr MK, Jensen CH, Toyserkani NM, Andersen DC, Damkier P, Sørensen JA, Lund L, Sheikh SP.


BACKGROUND: Prostate cancer is the most common cancer in men, and radical prostatectomy (RP) often results in erectile dysfunction (ED) and a substantially reduced quality of life. The efficacy of current interventions, principal treatment with PDE-5 inhibitors, is not satisfactory and this condition presents an unmet medical need. Preclinical studies using adipose-derived stem cells to treat ED have shown promising results. Herein, we report the results of a human phase 1 trial with autologous adipose-derived regenerative cells (ADRCs) freshly isolated after a liposuction.


METHODS: Seventeen men suffering from post RP ED, with no recovery using conventional therapy, were enrolled in a prospective phase 1 open-label and single-arm study. All subjects had RP performed 5-18 months before enrolment, and were followed for 6 months after intracavernosal transplantation. ADRCs were analyzed for the presence of stem cell surface markers, viability and ability to differentiate. Primary endpoint was the safety and tolerance of the cell therapy while the secondary outcome was improvement of erectile function. Any adverse events were reported and erectile function was assessed by IIEF-5 scores. The study is registered with, NCT02240823.


FINDINGS: Intracavernous injection of ADRCs was well-tolerated and only minor events related to the liposuction and cell injections were reported at the one-month evaluation, but none at later time points. Overall during the study period, 8 of 17 men recovered their erectile function and were able to accomplish sexual intercourse. Post-hoc stratification according to urinary continence status was performed. Accordingly, for continent men (median IIEFinclusion = 7 (95% CI 5-12), 8 out of 11 men recovered erectile function (IIEF6months = 17 (6-23)), corresponding to a mean difference of 0.57 (0.38-0.85; p = 0.0069), versus inclusion. In contrast, incontinent men did not regain erectile function (median IIEF1/3/6 months = 5 (95% CI 5-6); mean difference 1 (95% CI 0.85-1.18), p > 0.9999).


INTERPRETATION: In this phase I trial a single intracavernosal injection of freshly isolated autologous ADRCs was a safe procedure. A potential efficacy is suggested by a significant improvement in IIEF-5 scores and erectile function. We suggest that ADRCs represent a promising interventional therapy of ED following prostatectomy.

Current Perspectives on Stem Cell Therapy for Erectile Dysfunction.

 Sex Med Rev. 2016 Jul;4(3):247-256. doi: 10.1016/j.sxmr.2016.02.003. Epub 2016 Mar 19.

Authors: Peak TC, Anaissie J, Hellstrom WJ.


INTRODUCTION: Erectile dysfunction (ED) is a common sexual disorder that affects the lives of millions of male patients and their partners. Various medical and surgical therapies exist, with the most common being oral intake of phosphodiesterase 5 inhibitors. One therapeutic strategy in preclinical development to treat ED is stem cell transplantation.


AIM: To examine the studies that have investigated stem cells for the treatment of ED.


METHODS: A literature review was performed through PubMed focusing on stem cells and ED.


MAIN OUTCOME MEASURES: An assessment of different types of stem cells and how they may be applied therapeutically in the treatment of ED.


RESULTS: The stem cell types that have been investigated for the treatment of ED include bone marrow-derived mesenchymal, adipose-derived, muscle-derived, testes, urine-derived, neural crest, and endothelial progenitor. Depending on the cell type, research has demonstrated that with transplantation, stem cells exert a paracrine effect on penile tissue, and can differentiate into smooth muscle, endothelium, and neurons.


CONCLUSION: Multiple stem cell lines are currently being studied for their potential to treat ED. To date, stem cells have proven safe and effective in both animal and human models of ED. More research is needed to understand their full therapeutic potential.

Stem Cells in Male Sexual Dysfunction: Are We Getting Somewhere?

 Sex Med Rev., 2017;5:222-235.

Authors: Soebadi MA, Milenkovic U, Weyne E, Castiglione F, Albersen M.


INTRODUCTION: Stem cells for sexual disorders are steadily being introduced into clinical trials. Two conditions of importance are the main target for this line of treatment, especially when regarding the wide array of translational and basic science highlighting the potential advantages of regenerative therapy: erectile dysfunction (ED) and more recently Peyronie disease (PD). Cellular therapy offers a treatment modality that might reverse disease progression. It would be used in a curative setting, in contrast to other pharmaceutical agents that are currently available.


AIM: To review basic preclinical studies and recent clinical trials of stem cells on ED and PD.


METHODS: A search of the medical literature for the following terms was performed using PubMed: stem cells, cellular therapy, erectile dysfunction, Peyronie's disease, and clinical trial.


MAIN OUTCOME MEASURES: A non-systematic narrative review and critical reflection on preclinical and clinical studies administering stem cells for ED and PD in animal models and human subjects.


RESULTS: Numerous studies have confirmed the beneficial functional effects of stem cell injection in established animal models on ED and PD. Various stem cell types have been adopted, from embryonic to adult mesenchymal cell types. Each cell type offers distinctive advantages and disadvantages. Diverse administrations of stem cells were investigated, with insignificant variability in the ultimate results. Stem cells appear to have a pronounced paracrine effect, rather than the classic engraftment and differentiation hypothesis. Phase 1 clinical trials using stem cells have not reported any severe adverse events in animals. However, these results cannot be extrapolated to draw any conclusions about efficacy in human patients.


CONCLUSION: Stem cells have an established efficacy in preclinical studies and early clinical trials. Studies are currently being published demonstrating the safety of intrapenile injection of autologous bone marrow- and adipose tissue-derived stem cells. Soebadi MA, Milenkovic U, Weyne E, et al. Stem Cells in Male Sexual Dysfunction: Are We Getting Somewhere?