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Minimal Invasive

Stem Cell

Therapy for ED

Stem cell therapies are one of the most important topics on which hope is built for the treatment of many chronic diseases and scientists study very hard. Because of both ethical concerns and unpredictable potentials for side effects, stem cell therapies have not yet been fully introduced into clinical use. In the patient handbook published by the International Society for Stem Cell Research (ISSCR), they expressed concern about stem cell therapies becoming a commercial meta worldwide. Because the vast majority of stem cell therapies evaluated within the scope of regenerative medicine are new and experimental. At this stage, it is still highly doubtful whether they treat diseases or not. It is of great benefit for patients to be aware of this when demanding stem cell therapy. However, considering the last 20 years, it is obvious that most of the in vitro tissue and in vivo animal studies have achieved positive and satisfactory results. Human-based clinical studies have been initiated for this purpose and the results are eagerly and enthusiastically expected by the scientific community. Nevertheless, all these processes are progressing very slowly and there will unfortunately be no time for the majority of our current patients to wait for the study data to mature. In this case, we think that there is a need for some practical stem cell therapy approaches that will not compromise patient health, not abuse the patient ethically, and will yield positive results.

The prevalence of ED in men aged 40 to 70 years is approximately 50%. About 15% of men suffering from ED unfortunately do not respond to first-line and second-line therapies. In other words, one group of patients cannot obtain an erection of adequate quality to allow sexual intercourse despite the medications in both oral and injection forms. Only one option is left for patients with such condition, which is penile implant surgery. Although current penile implants provide an erection very close to physiology, a significant proportion of the patients stand aloof from this treatment modality. Or some uncontrolled chronic diseases constitute an important obstacle for the individual to undergo such an operation. Can regenerative and restorative stem cell therapies for the penis be an alternative in this case?  It is obvious that the forthcoming years will bring about important developments. In fact, stem cell therapies have already been introduced into clinic use for the treatment of ED in some centers in the last few years and a limited number of published studies have shown that they may have positive effects. In summary, although there are many unknown and unclear issues, stem cell therapies are an extremely new and promising theurapeutic approach for the treatment of erectile dysfunction.

WHY DO WE PREFER TO USE BONE MARROW-DERIVED STEM CELLS?

Erectile dysfunction occurs as a result of an extremely complex pathophysiological process. The main problem at this point is endothelial damage and vascular pathologies.  Furthermore, with the contribution of neuropathic conduction problems, severe loss of elasticity of cavernosal tissue develops as a result of the accumulation of fibrinogen in smooth muscle tissues. The primary goal in the treatment process is undoubtedly to ensure the formation of new vessels within the cavernosal tissues of the penis. Bone marrow-derived aspirates have a rich content of mesenchymal and hematopoietic stem cells along with angioblasts, endothelial progenitor cells, cytokines and growth factors. Scientific studies have shown that hematopoietic stem cells are of great importance especially in the process of new vessel formation (angiogenesis). For these reasons, bone marrow should be the reason for preference in the stem cell therapy of ED. However, only mesenchymal stem cells can be derived from the stem cells taken from the abdominal adipose tissue. Mesenchymal stem cells, on the other hand, are known to contribute to the development of muscle, bone, cartilage, connective tissues and nerve cells. This is the main reason for preferring stem cells of adipose tissue origin in clinical practice in the fields of orthopedics and plastic surgery.  For the heart and penis, which is a very similar organ to the heart, bone marrow is considered to be a much more ideal stem cell source. Moreover, the majority of stem cells and progenitor cells in the bone marrow are already viable and active elements. It is considered that the existing content will be more effective in the healing process, even if it is small in number. The stem cells derived from adipose tissue are generally silent (dormant) elements. In order to be activated, they require to be subjected to some additional processes in the laboratory.

SEPARATION & CONCENTRATION PROCEDURE

IS BONE MARROW ASPIRATION A DIFFICULT PROCEDURE?

Derivation of bone marrow is not a difficult procedure that will restrain the individual from his/her daily life. It is even a much more effortless technique compared with liposuction. We most commonly prefer the proximal tibia (leg bone between the knee and ankle) to derive bone marrow. We use the FDA approved “Bio-MAC Bone Marrow Aspiration Catheter" system. In this system, brute force and mallet are not used. We can easily obtain as many bone marrow samples as we want atraumatically within 5 minutes through a small hole opened using a surgical drill. General anesthesia is not needed during this procedure. Only sedatives, local anesthetics and simple painkillers are usually sufficient. Postoperative pain is much less since no microfracture occurs around the bone when the Bio MAC catheters are used, unlike conventional bone marrow catheters. The patient can easily stand up and walk without problem 2 hours after the procedure. Therefore, there is no reason to discontinue daily work or holiday.

HOW MUCH STEM CELL CAN BE DERIVED WITH THE MACELLAN TECHNOLOGY?

It has been shown that mesenchymal (CD105+ CD73 +) and hematopoietic (CD34 + CD133 +) stem cells can be concentrated up to 5-6 times with the Magellan® technology. At this point, the cells derived have been found to be 97% viable.  Up to 1 million mesenchymal stem cells (MSCs) and 2 million hematopoietic stem cells (HSCs) can be obtained from each ml of concentrated fluid. As specified earlier, progenitor cells, platelets lymphocytes, monocytes, growth factors (TGF-β, IGF-1, PDGF, VEGF) and anti-inflammatory cytokines are abundantly found in the same concentrated fluid.

The aspiration material derived from bone marrow is first subjected to a simple filtration process. The separation and concentration of stem cells from hematogenic red blood elements are then performed using a completely FDA-approved device, the MAGELLAN® technology. With the help of this device with a closed-loop automated system and the Magellan® MAROMax ™ kit, the separation procedure is initiated. The device immediately adapts to the individual's bone marrow biology and starts to separate hematopoietic, mesenchymal stem cells, progenitor cells from other red blood elements with the help of its optic sensors. As a result, 6 ml of reddish suspension rich in mononuclear cells is obtained from 60 ml of bone marrow aspirate. The separation procedure takes about 16-18 minutes in total. If the patient is suffering from severe erectile dysfunction for a long time or ED developed due to radical prostatectomy, it is possible to obtain a total of 12 ml of suspension by taking 120 ml of bone marrow and using 2 different kits.

WHAT ELSE CAN BE DONE AFTER THE PROCEDURE?

If there is no contraindication, it would be appropriate to use Tadalafil 5 mg tablets daily. The primary goal at this point is to make the individual's cavernosal system responsive to drugs again. We also recommend using VibErect® vibration for 10 minutes per day in the home environment, especially for the first month. In addition, 3-6 sessions of Li-ESWT program can also be optionally included in the process immediately after the The Magellan BMAC procedure. Li-ESWT is an additional treatment modality that we recommend in order to obtain better and faster results.

HOW IS THE PROCEDURE PERFORMED?

The derived 6 ml of suspension of bone marrow origin is freshly administered to the patient immediately at the same time. For this purpose, the penis skin is first numbed with the help of local anesthetic creams. An equal amount of fluid content is injected intracavernosally into a total of 4 different quadrants on the right and left sides of the penis. In this procedure, the patient does not develop any side effects except for temporary and mild injection site pain. During the procedure, the penis is clamped from the base for 10 minutes.

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Advantages of Magellan BMAC® Prosedure

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  • The Magellan BMAC, ED is a fast, effective and alternative solution for ED problem. After a total of about 1 hour period, autologous stem cells derived from the individual's own bone marrow are injected into the penis.

  • The Magellan BMAC is a cost-effective procedure. Conventional stem cell separation requires an advanced stem cell laboratory. And these treatments are quite expensive and time-consuming.

  • The Magellan BMAC can be performed in office conditions. It does not require general anesthesia and hospitalization. After a resting period of 6 hours, it allows patients to return to their daily lives.

  • The Magellan BMAC has a low side effect potential. As stem cells are proliferated in the laboratory setting, the possibility of developing malignant transformation arises. This is the most worried complication of classical stem cell therapies. In CaverStem, stem cells are proliferated by culturing. Therefore, the malignant transformation of cells is unlikely.

  • The Magellan BMAC is an effective stem cell therapy. Visible results begin to be obtained within 1 month after the therapy. If desired or needed, the second procedure can be performed after 1-2 months.

  • All devices and equipment used in The Magellan BMAC are FDA-approved. The FDA has also approved the use of this system for therapeutic purposes in orthopedic diseases. On erectile dysfunction, clinical studies are still ongoing and the first data are satisfactory. Our own observation is that The Magellan BMAC procedure is safe and effective in the treatment of erectile dysfunction.

  • If the patient's erection problem is too severe, 120 ml bone marrow can be derived instead of 60 ml by using two kits during the bone marrow aspiration. While 6 ml of this can be freshly administered instantly, the remaining 6 ml concentrate can be cryopreserved in liquid nitrogen tanks at - 196 °C. After the concentrate is thawed 1-2 months later, the second The Magellan BMAC procedure can be carried out effortlessly within 10 minutes as part of a one-day visit.

information

FDA approved 

Magellan technology

device

FDA approved

Magellan MaroMAX kit

FDA approved

Bio-MAC

Bone Marrow Aspiration Catheter

About

60 minutes

Official

prosedure 

Minor potantial side effects

Stand up and walk without problem 2 hours after the procedure.

Back to work

the next day

Results occur 4 weeks after prosedure

Stronger& firm

erections

Increased

sexual desire

and pleasure

Cryopreservation option

 
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REFERENCES

Phase I and registry study of autologous bone marrow concentrate evaluated in PDE5 inhibitor refractory erectile dysfunction

Mark BieriElias SaidGabrielle AntoniniDonald DickersonJorge TumaCourtney E. BartlettAmit N. Patel,and Alexander Gershman

J Transl Med. 2020; 18: 24.

 

Intracavernous administration of bone marrow mononuclear cells: a new method of treating erectile dysfunction?

Thomas E Ichim, Timothy Warbington, Octav Cristea, Joseph L Chin, Amit N Patel   Journal of Translational Medicine 2013, 11:139

 

Stem and endothelial progenitor cells in erection biology

TD Strong, MA Gebska, HC Champion, AL Burnett and TJ Bivalacqua

International Journal of Impotence Research (2008) 20, 243–254

 

Bone Niches, Hematopoietic Stem Cells  and Vessel Formation

Roberto Tamma and Domenico Ribatti

Int. J. Mol. Sci. 2017, 18, 151

 

Stem Cell Therapy for Erectile Dysfunction

Ethan L. Matz, MD, Ryan Terlecki, MD, Yuanyuan Zhang, MD, PhD, John Jackson, PhD,and Anthony Atala, MD

Sex Med Rev 2018;-:1e8

 

A Systematic Review of Human Trials Using Stem Cell Therapy for

Erectile Dysfunction

Soum D. Lokeshwar, BS, Premal Patel, MD, Serena M. Shah, BS-Candidate, and Ranjith Ramasamy, MD

Sex Med Rev 2019;-:1e9

 

Stem-cell therapy for erectile dysfunction

R. Yiou

Bio-Medical Materials and Engineering 28 (2017) S81–S85

 

Fibroblasts as a practical alternative to mesenchymal stem cells

Thomas E. Ichim, Pete O’Heeron and Santosh Kesari

Ichim et al. J Transl Med (2018) 16:212

 

Combination of low‑energy shock‑wave therapy and bone marrow mesenchymal stem cell transplantation to improve the erectile function of diabetic rats

Hai‑Tao Shan, Hai‑Bo Zhang, Wen‑Tao Chen

Asian Journal of Andrology (2017) 19, 26–33

 

Efficient Promotion of Autophagy and Angiogenesis Using Mesenchymal Stem Cell Therapy Enhanced by the Low-Energy Shock Waves in the Treatment of Erectile Dysfunction

Guan Qun Zhu ,1 Seung Hwan Jeon,1 Woong Jin Bae

Stem Cells International Volume 2018, Article ID 1302672, 14 pages

 

Stem cell therapy in diabetic men with erectile dysfunction: a step closer to safe and effective regenerative technology

 Eric Chung

 Ann Transl Med 2019;7(Suppl 1):S40

 

Adipose Tissue-Derived Stem Cell Therapy for Cavernous Nerve Injury-Induced Erectile Dysfunction in the Rat Model: A Systematic Review and Meta-Analysis Using Methodological Quality Assessment

Hyo Jung Park, Hyunsuk Jeong

International Journal of Stem Cells Published online April 30, 2019

 

Stem Cell Therapy for Erectile Dysfunction: A Critical Review

Ching-Shwun Lin,1 Zhong-Cheng Xin

STEM CELLS AND DEVELOPMENT Volume 21, Number 3, 2012

 

A Role for Hematopoietic Stem Cells in Promoting Angiogenesis

Nobuyuki Takakura, Toshio Watanabe,

Cell, Vol. 102, 199–209, July 21, 2000

 

The Instructive Role of the Vasculature in Stem Cell Niches

Andrew J. Putnam

Biomater Sci. 2014 November ; 2(11): 1562–1573