STEMCELL TRANSPLANTATION THERAPY IN CHRONIC KIDNEY DISEASE

Transcription

1 STEMCELL TRANSPLANTATION THERAPY IN CHRONIC KIDNEY DISEASE NEW THERAPY TO REDUCE THE NEED FOR KIDNEY TRANSPLANT AND DIALYSIS Diabetes mellitus is the degenerative disease of the 21st century with more and more "epidemiological" features, with increasing incidence and prevalence rates. The chronic disturbance of the blood sugar levels still causes problems in the body such as blurred vision, rashes on the skin, hard to heal wounds, libido disorder and nerve damage. In severe cases, diabetes disturbs blood supply to the kidneys, which in turn can cause renal failure (diabetic nephropathy). Ca. 50% of kidney failure in the Western countries are in fact caused by diabetes. For the majority of the patients on the waiting list for kidney transplantation who are diagnosed with chronic kidney failure it means making a choice between dialysis and, sooner or later, a certain death! Dialysis takes both time and money. Most patients go to the dialysis center 3 times a week and each treatment also lasts for about 4 hours! In the Netherlands, the annual costs associated with these treatments ( per patient) are getting higher and higher. A single kidney transplant is equivalent in cost to 2 ½ years of dialysis, but finding the right donor match takes on average 4 years per person! Ca. 20% of the terminal renal failure is caused by hypertension (hypertensive renopathie). It is for this reason that we also include this not insignificant condition in this study. In this Clinical trial we will limit ourselves to these two major disease categories as the causes of Chronic Kidney Disease that can often lead to kidney failure. DKF Research Grant Kidney Regeneration JD Setyo 1

2 Who are we and what do we do? I was educated at the Erasmus University Rotterdam. My areas of interest are, in addition to cosmetic surgery (like liposuction + autologous SCT + fat graft), also natural medicine: acupuncture / homeopathy and orthomolecular medicine. The postdoctoral choice for the research I did in at the Department of Pediatric Surgery with Dr. AP Provoost during his research was on the effect of partial and total urethral obstruction on renal function in rats. As a private clinic we have, since the beginning of 2015 (inspired by American, Swiss and Chinese colleagues working in the field of Stem Cell Transplantation), begun developing and administering the applied stem cell treatments as easily, safely and naturally as possible using techniques that I have learned in California, USA. This is very important in order to avoid manipulating the vulnerable stem cells negatively, e.g. by a cultivation process somewhere outside the body, with or without the use of some chemical agents and / or complicated equipment. At first we have been focused only on treating patients with various complaints in the musculoskeletal field, usually with amazing results. In my daily practice in my clinic, I am assisted by my wife (a full-time acupuncturist), my oldest son (final year medical training, with good prospects for specialization in Surgery) and a full time nursing assistant. Incidentally my 2nd son (dentistry student) also helps. See: The last five months we have been working hard to develop and apply for a patent for a simple device for safely administering harvested MSCs into solid organs such as the pancreas, kidney, etc. (with the use of ultrasound echography for guidance). Our clinic has recently been equipped with an advanced ultrasound machine for these purposes. We also successfully supervise many people who want to lose weight drastically, using for instance the so-called 0-Cal. Diet". Being overweight by too much and / or having the wrong food intake is a major risk factor for these diseases of affluence. In the context of this holistic approach this will also be implemented. After awarding the Grant to us, I ll hire a few more colleagues and medical students to, among other things, include the processing of the data for the statistics. DKF Research Grant Kidney Regeneration JD Setyo 2

3 Why do we apply for this Grant? It is a sad fact that in the last 40 years there have been no significant innovative developments worldwide in the field of treating chronic renal failure as an alternative for kidney transplantation or dialysis. Worldwide we are currently in research phase 3. With the use of current science and techniques in relatively "simple" stem cell technology, via adult autologous adipose-derived Mesenchymal Stem Cells from the abdominal region, we do our best to help people with impending kidney failure in order to minimize the need for a transplant or dialysis for longer term. Depending on the results, we will make the calculations for cost / benefit analysis in health care costs. All treatments are done in our clinic in Rotterdam ('s-gravenweg 637) and each treatment lasts for one hour for Alternative therapies and up to 5 hours for Stem Cell Transplantation therapy in the kidneys and pancreas. DKF Research Grant Kidney Regeneration JD Setyo 3

4 What are we going to do? One of the reasons that kidney failure happens this often is the inability of our kidneys to form new nephrons. Mesenchymal Stem Cells are the natural defenses of the body against kidney damage. Originally from the bone marrow, these stem cells are to protect the kidneys from damage and they accelerate healing. Epithelial renal cells after injury have been replaced, however, are derived from the epithelium itself, rather than from interstitial stem cell population that does not contain any specific population of proximal tubules cells. This is normally considered to be responsible for the replacement of kidney dead cells. From several animal studies and from Clinical Trial by Mayo Clinic, USA (National Institutes of Health, published in "Stem Cells" in September 2014) it is known that adult autologous adipose-derived mesenchymal stem cells (AAD MSC) from the abdominal fat tissue possess qualities capable of effecting the regeneration of the nephron as a functional unit of the kidney. See: Enclosure 2. After harvesting the abdominal adipose tissue via mini PAL liposuction 2x 450 cc. SVF (stromal vascular fluid) are collected in a sterile canister of MicroAir. See: Enclosure 3. Subsequently these are centrifuged, in a centrifuge specifically manufactured for this purpose, for 10 minutes at 1000xG. After the activation of the isolated MSC in order to bring them quickly in the S- phase by means of PRP and green laser light (specially programmed for this treatment), we are going to administer part of the stem cells directly in the kidneys (and in the pancreas in the case of diabetes). The other part we are going to inject, under the guidance of ultrasound, via the facilitating artery. Often they are the relatively "simple" methods, that give great results! After 2 weeks, the stitches of the small incisions are removed. Depending on the group in which someone is sitting, the patient is further treated with standardized protocols. According to schedule the standardized research parameters (both clinical, incl. any side-effects, and biochemical) will be implemented and maintained. DKF Research Grant Kidney Regeneration JD Setyo 4

5 Which groups are in our Clinical Trial? Group 1: 5 people with diabetes in whom only SCT is to be applied Group 2: 5 people with diabetes are to be treated with SCT + Alternative Therapies Group 3: 5 people with diabetes are to be treated with PRP + Alternative Therapies Group 4: 2 people with hypertension in whom only SCT is to be applied Group 5: 2 people with hypertension to be treated with SCT + Alternative Therapies Group 6: 2 people with hypertension to be treated with PRP + Alternative Therapies Group 7: 4 people with the combination Diabetes and Hypertension are to be treated with SCT + Alternative Therapies + slimming treatments ( multifactorial holistic approach ) NB Group 3 & 6 we consider as a "control group". People in the groups 3 & 6 are only receiving PRP / platelet rich plasma and Alternative Therapies such as acupuncture, fine-tuned Asyra Homeopathy, Neural Therapy and Orthomolecular therapy (multidisciplinary). All patients will be randomly placed and no one will know whether he/ she is going to get or already got real Stem Cell Transplantation (blind). All procedures will be administered strictly according to protocol and will be standardized for reproducibility. Before the procedure, everyone gets a detailed medical history, GFR and serum creatinine research and checkup. That is repeated 3 weeks, 3 months, 6 months, 12 months, 18 months, 24 months and, if needed, three years after the surgery. All data and procedures will be studied and observed by the watchful eyes of medical students of the Erasmus University Rotterdam who have great interest in both Regular and Alternative or Regenerative Medicine. In case of deterioration of the condition / test result the patient is sent to the Erasmus MC. DKF Research Grant Kidney Regeneration JD Setyo 5

6 What criteria will be used? Inclusion criteria: Men and women between the ages of 20 to 60 years The BMI between 25 and max. 34 With well-known symptoms of chronic kidney disease With GFR between 25 to 50 ml/ min./ 1.73 m2 With the ability to understand and willingness to sign the "informed consent" Exclusion criteria: Acute renal failure or fever in the last week prior to the procedure Pregnancy or breast feeding or women of childbearing age who are not willing to take contraceptive measures for the duration of the study Diabetes requiring clinical medical intervention Severe co-morbidity in the field of CVD Other systemic diseases such as cancer, autoimmune diseases, sepsis, anemia, STD, liver disease, and other metabolic disorders, HIV/ AIDS etc. in which the kidneys may be involved Hospitalization due to illness in the past two months Diseases such as drugs, alcohol, cigarettes, sex and gambling addiction Life expectancy of less than one year Undergoing other experimental study Illness or other circumstances where the safety of the patient may endanger or that may interfere with or could negatively effect (the results of or the interpretation of) the study The use of chronic immunosuppressive therapy Systolic blood pressure <90 mm Hg or >200 mmhg at RR Resting heart rate >100 per minute Mental or other brain disease History of cancer in the last five years DKF Research Grant Kidney Regeneration JD Setyo 6

7 What are the expectations and prospects? Schedule: 1. First year: Recruiting suitable candidates via G.P.s and starting the procedures 2. Second year: Collecting check-ups and clinical chemistry-lab values 3. Third year: Completing all evaluations and computing all the data of statistics 4. Fourth year: The report, supported by literature from the whole world, reporting entirely in English first at the Kidney Foundation and, with her consent, publishing if necessary Through the treatments that are described in this clinical trial we want to achieve the recovery and healing process in people with imminent kidney failure so that less dialysis and transplantation will be used and this can be mapped as closely as possible. We expect that everybody (possibly including those of the so-called "Control group, since even the placebo can have a positive effect) within 6 months after initiation of the proceedings (Which size? / how long?) will notice strong life-enhancing improvements, compared with their situation and condition before SCT or under the regular techniques. Then it will be exciting and hopefully very groundbreaking! By further continuing to monitor the health parameters via standardized questions, GFR measurements and possibly serum creatinine to (up to) 3 years we want to compare and evaluate the clinical significance of the results of these treatments in the seven study groups. Based on that, we can do an assessment and recommendation, including how often the SCT treatments must be repeated. Since the SCT therapy, as we apply it in the Netherlands, is in a very early stage of development, we would like to achieve with the aid of this Grant the ability to accelerate these developments. The Clinical results of this trial will also form part of spreading the right information to Dutch people, kidney patients, organizations / authorities and health insurance companies. This clinical experimental research will, if necessary, also be used as a basis for my as yet to be written book and PhD research at the Erasmus Medical Centre in Rotterdam. DKF Research Grant Kidney Regeneration JD Setyo 7

8 P.S. Not long ago I met a brother in the church, where I always go for years. He is one of the collectors for, and very active in, the Kidney Foundation. Currently he is in the research phase to donate one of his kidneys to a young confrere with Alport s disease, because the kidney from his father transplanted five years ago is already almost failing. He informed me about the Grant of the Dutch Kidney Foundation. Below follows a plea from a friend who is well known to the Kidney Foundation: Commentary by Robert van der Wolk: My name is Robert van der Wolk, born on Nov 12 th 1981 and currently living in Haarlem. As a person with diabetic nephropathy (since my 8th year of life familiar with DM type 1) I had had a kidney / pancreas transplant in 2012, after a period of dialysis for nearly 2,5 years. Although the transplant was successful, the treating hospital was unable to get the relapse under control due to medication overdose. Alternatively I found a clinic in Germany that uses holistic and alternative treatment methods. After a short treatment period of 8 days, both the cause of relapse as well as the associated symptoms had disappeared almost entirely. Research on Alternative Medicine in the field of prevention of renal failure and/ or prevention of a transplant is in my view a necessity for all parties which includes health insurance, government, hospitals, Dutch Kidney Foundation and obviously the kidney patients themselves, in order to prolong the future of a healthy functioning kidney. As a strong proponent of Alternative and Holistic Medicine, as well as the latest developments in the scientific area, I support this proposal for an investigation where alternative (less invasive) treatments are involved in order to improve the quality and longevity of (future) kidney patients. DKF Research Grant Kidney Regeneration JD Setyo 8