GENERAL STEM CELL FAQ
BEFORE CELL THERAPY
GENERAL STEM CELL FAQ
Why do you use SVF and not pure stem cells?
Instead of using pure stem cells, our Integrative Cell Therapy programs utilize stromal vascular fraction (SVF). This is an extract, derived from fat tissue, which contains stem cells as well as a whole array of other important cells, exosomes and growth factors.
Stromal vascular fraction is a very complex substance. In fact, science has not yet identified all components found in SVF. What we do know is that the growth factors contained in SVF can turn off an inflammatory response. They can also cause cells to multiply and the can call in specialized cells to perform specific functions.
Studies indicate that stromal vascular fraction does much more than simply repair. It’s application triggers a systemic response, activating the body’s ability to regulate cell function and promote healing. Stromal vascular fraction and it’s use in cell therapy is very well researched and is safe to use.
INFUSIO® uses adipose derived stem cells for deployment & clinical research. Early stem cell research has traditionally been associated with the controversial use of embryonic stem cells. The new focus is on non-embryonic adult mesenchymal stem cells which are found in a person’s own blood, bone marrow, and fat. Cell therapy around the world is shifting its focus from bone marrow based cells to adipose (fat) derived cells since the cells are easy to obtain and generally very robust. Adipose fat is an abundant and reliable source of stem cells. The best quality adipose cells are derived from the enzymatic digestion of liposuctioned fat which can be performed at the bedside in an essentially closed system to protect sterility. Autologous stem cells from a person’s own fat are easy to harvest safely under local anesthesia and are abundant in quantities up to 2500 times those seen in bone marrow.
Once these adipose derived stem cells are administered back in to the patient, they have the potential to repair human tissue by influencing healing and also forming new cells of mesenchymal origin, such as cartilage, bone, ligaments, tendons, nerve, fat, muscle, blood vessels, and certain internal organs. Stem cells’ ability to form cartilage and bone makes them potentially highly effective in the treatment of degenerative orthopedic conditions. Their ability to form new blood vessels and other tissues makes them suitable for mitigating a large number of traumatic and degenerative conditions.
We have anecdotal and experimental evidence that stem cell therapy is effective in healing and regeneration. Stem cells seek out damaged tissues in order to repair the body naturally. The literature and internet is full of successful testimonials but we are still awaiting definitive studies demonstrating efficacy of stem cell therapy. Such data may take five or ten years to accumulate. In an effort to provide relief for patients suffering from certain degenerative diseases that have been resistant to common modalities of treatment, we have initiated pilot studies as investigational tests of treatment effectiveness with very high numbers of adipose derived stem cells obtained from fat.
Our treatments and research are patient funded and we have endeavored successfully to make it affordable. All of our sterile procedures are non-invasive and done under local anesthesia.
Adult (not from embryonic source) Mesenchymal Stem Cells are undifferentiated cells that have the ability to replace dying cells and regenerate damaged tissue. These special cells seek out areas of injury, disease and destruction where they are capable of regenerating healthy cells and enabling a person’s natural healing processes to be accelerated. As we gain a deeper understanding of their medical function and apply this knowledge, we are realizing their enormous therapeutic potential to help the body heal itself. Adult stem cells have been used for a variety of medical treatments to repair and regenerate acute and chronically damaged tissues in humans and animals. Although adult stem cells are found in many organs, they are very accessible in high numbers from fat. Other sources of stem cells such as “amniotic” products which are commercially available are not from one’s own body and these cells are gamma radiated by the manufacturer and therefore are not live cells. If you have been offered amniotic cells from some source, one should be aware of this fact.
The use of stem cells is not FDA approved for the treatment of any specific disease in the United States at this time and their use is therefore investigational. Many reputable international centers have been using stem cell therapy to treat various chronic degenerative conditions as diverse as severe neurologic diseases, renal failure, erectile dysfunction, degenerative orthopedic problems, and even cardiac and pulmonary diseases to name a few. Adult stem cells appear to be particularly effective at repairing cartilage in degenerated joints.
Regenerative Medicine is the process of creating living, functional tissues to repair or replace tissue or organ function lost due to damage, or congenital defects. This field holds the promise of regenerating damaged tissues and organs in the body by stimulating previously irreparable organs to heal themselves. (Wikipedia)
A stem cell is basically any cell that can replicate and differentiate. This means the cell can not only multiply, it can turn into different types of tissues. There are different kinds of stem cells. Most people are familiar with or have heard the term “embryonic stem cell.” These are cells from the embryonic stage that have yet to differentiate – as such, they can change into any body part at all. These are then called “pluri-potential” cells. Because they are taken from unborn or unwanted embryos, there has been considerable controversy surrounding their use. Also, while they have been used in some areas of medicine – particularly, outside the United States – they have also been associated with occasional tumor (teratoma) formations. There is work being conducted by several companies to isolate particular lines of embryonic stem cells for future use.
Another kind of stem cell is the “adult stem cell.” This is a stem cell that already resides in one’s body within different tissues. In recent times, much work has been done isolating bone-marrow derived stem cells. These are also known as “mesenchymal stem cells” because they come from the mesodermal section of your body. They can differentiate into bone and cartilage, and probably all other mesodermal elements, such as fat, connective tissue, blood vessels, muscle and nerve tissue. Bone marrow stem cells can be extracted and because they are low in numbers, they are usually cultured in order to multiply their numbers for future use. As it turns out, fat is also loaded with mesenchymal stem cells. In fact, it has hundreds if not thousands of times more stem cells compared to bone marrow. Today, we actually have tools that allow us to separate the stem cells from fat. Because most people have adequate fat supplies and the numbers of stem cells are so great, there is no need to culture the cells over a period of days and they can be used right away.
These adult stem cells are known as “progenitor” cells. This means they remain dormant (do nothing) unless they witness some level of tissue injury. It’s the tissue injury that turns them on. So, when a person has a degenerative type problem, the stem cells tend to go to that area of need and stimulate the healing process. We’re still not sure if they simply change into the type of injured tissue needed for repair or if they send out signals that induces the repair by some other mechanism. Suffice it to say that there are multiple animal models and a plethora of human evidence that indicates these are significant reparative cells.
What is the difference between blood and fat stem cells?
The fat-derived stem cells contained in stromal vascular fraction are newer development and evolved from the research we did with blood stem cells. SVF containing fat stem cells have proven to be more versatile in their application especially when treating neurological symptoms. We can say at this point based on our research and our positive results we recommend SVF cell therapy to almost all of our patients. An additional benefit when using SVF, Mannitol can be used to open the blood-brain brain barrier. This was not possible with blood stem cells. Also, later in the process the SVF triggers the release of blood stem cells in the system so with fat stem cells you’re getting more rather than less.
No. INFUSIO® practices foundational medicine and targets to establish a healthy function of core body systems. Stem cells aid in repair work and cell-to-cell signaling. Once a healthy regulation capacity is reestablished the body is able to address the Lyme bacteria and related symptoms.
This will depend on the type of degenerative condition you have. A specialist will evaluate you and discuss whether you’re a potential candidate for stem cell therapy. If after you’ve been recommended for treatment, had an opportunity to understand the potential risks and benefits, and decided on your own that you would like to explore this avenue of treatment, then you can be considered for treatment. Of course, even though it’s a minimally invasive procedure, you will still need to be medically cleared for the procedure.
- However, INFUSIO®’s surgical procedures fall under the category of physician’s practice of medicine, wherein the physician and patient are free to consider their chosen course of treatment. The FDA does have guidelines about treatment and manipulation of a patient’s own tissues. At INFUSIO® we meet these guidelines by providing same day treatment with the patient’s own cells that undergo no manipulation and are inserted during the same procedure.
No. Only adult mesenchymal stem cells are used. These cells are capable of forming bone, cartilage, fat, muscle, ligaments, blood vessels, and certain organs. Embryonic stem cells are associated with ethical considerations and limitations.
Bone marrow sampling (a somewhat uncomfortable procedure) yields approximately 5,000 – 60,000 cells that are then cultured over several days to perhaps a few million cells prior to deployment (injection into the patient). Recent advances in stem cell science have made it possible to obtain high numbers of very excellent quality multi-potent (able to form numerous other tissues) cells from a person’s own liposuction fat. INFUSIO® uses technology acquired from Asia to process this fat to yield approximately five hundred thousand to one million stem cells per cc of fat, and therefore, it is possible to obtain as many as 10 to 40 million cells from a single treatment. These adipose derived stem cells can form many different types of cells when deployed properly including bone, cartilage, tendon (connective tissue), muscle, blood vessels, nerve tissue and others.
Stem cells are harvested under sterile conditions using a special “closed system” technology so that the cells never come into contact with the environment throughout the entire process from removal to deployment.
Why do some stem cell facilities around the world require days to weeks before removal of mesenchymal stem cells until reinsertion into the patient?
These facilities are obtaining stem cells from bone marrow or blood in relatively small quantities and they are then culturing (growing) the cells to create adequate quantities. INFUSIO® uses adipose derived stem cells that are abundant naturally at approximately 2,500 times levels found in bone marrow (the most common source of mesenchymal stem cells). INFUSIO® uses technology that isolates adipose stem cells in vast numbers in a short time span so that prolonged culturing is unnecessary and cells can be deployed into a patient within 90 minutes of harvesting.
Stem cells have played an important role in cancer therapy for five decades. Hematopoetic stem cells (similar to mesenchymal stem cells and also found in stromal vascular fraction) have been used to restore bone marrow and replace blood cell lines after planned ablation of a cancer patient’s bone marrow. This is known as a “stem cell transplant” and is associated with significant risk to cancer patients. Of course, this is different than a regenerative therapy using stem cells to replace or repair damaged tissue. Having said that, new advances in cancer therapy have exploited stem cell property known as “TROPISM” which is the ability of stem cells to target tumors. This property has been used to help carry cancer killing agents deep into the cancer where the body’s immune system cannot always operate effectively. Infusio is involved in cutting edge clinical trials using stem cells to carry cancer-killing biologic agents deep into cancer tissue that has not responded to conventional therapy.
Adult mesenchymal stem cells are not known to cause cancer. Some patients have heard of stories of cancer caused by stem cells, but these are probably related to the use of embryonic cells (Not Adult Mesenchymal Cells). These embryonic tumors known as teratomas are rare but possible occurrences when embryonic cells are used.
Stem cell therapy is thought to be safe and not affect dormant cancers. If someone has had cancer that was treated and responded successfully, there is no reason to withhold stem cell deployment. In most cases, stem cells should not be used in patients with known active cancer outside of an active protocol (see “Can stem cells treat cancer”)
Are there reports of autologous adipose derived adult mesenchymal stem cells harming any humans or animals?
INFUSIO® follows all our outcomes and any adverse events and we have had extraordinary safety since we started treating patients in 2015 with adipose derived adult stem cells. All of our patients are entered into a database to follow and report even minor adverse reactions. This information is vital to the development of stem cell science. There have been a few reports of serious complications from associated with other technologies.
None. Our aim is to make cell based medicine available to patients who are interested and to provide ongoing research data under approved Institutional Review Board (IRB) validated studies. We will follow our stem cell treatment patients over their lifetimes. This will enable us to accumulate significant data about the various degenerative diseases we treat. Instead of providing simply anecdotal or testimonial information, our goal is to categorize the various conditions and follow the patient’s progress through various objective (e.g. x-ray evidence or video displays) and subjective (e.g. patient and/or doctor surveys) criteria. We are aware of a lot of stories about marked improvement of a variety of conditions, but we make no claims about the intended treatment. We have submitted preliminary safety data to the FDA as part of an approval application which is under consideration. Still, these are your own cells and not “medicines” for sale. They are only being used in your own body. Most likely, no claim needs to be made; rather a statistical analysis of our findings would suffice to suggest whether treatments are truly and significantly effective.
BEFORE CELL THERAPY
The following screening and admission process is required to become an INFUSIO® patient:
1. Submit Medical History
2. Get approved by medical team
3. Receive and Sign Cost Estimate
4. Once you have signed your cost estimate and submitted your 50% deposit you can be confirmed for our available dates.
Please keep in mind, dates do fill up quickly and until you are at the last stage of the process, we can not reserve your dates ahead of time. We recommend not booking travel or accommodations until you have completed the steps above to ensure there are no problems booking your desired date.
We do not recommend doing a mold treatment or remove metal implants in advance. These interventions may cause more damage than good since the body is in such a vulnerable state and may be over stimulated or overwhelmed by these procedures. The idea is to bring your body in a stable state and help it to regulate by itself again. Once the body systems are stabilized it will be easier for the body to deal with these kind of interventions if at all necessary still.
Yes. Long-term and chronic sickness can contribute to poor detoxification processes in the body. Also, methylation disruption is a common issue in a large patient population. The goal of our therapy is to open detox pathways and optimize detoxification processes in the body. Methylation issues are genetic. Through stem cell therapy it is not possible to change our genetics. That having been said, our theory is that methylation snps cause cumulative damage to our cells and our system. With our treatment, we can repair and reset the cumulative damage, thus bringing the cells back to their original healthy state. As the methylation snp still remains, this cumulative process will have been reset, but will continue. Now that the cells are optimized and with the awareness of the snp, it should be possible to manage the mutation, considerably slowing down the process leading to cell and systemic damage.
The chemical makeup of calcium EDTA limits its ability to chelate various metals. Therefore INFUSIO® uses calcium EDTA not for chelation but rather to optimize the cell function optimize the detox pathways and reduce oxidative stress. By using it in combination with other substances we can limit or avoid damage to soft organs through redistribution of metals. It is important to combine CaEDTA with ROS scavengers and antioxidants to avoid strong detox reactions. CaEDTA is an integral part of the supportive therapies and a foundational therapy that should not be omitted.
The INFUSIO® IV protocols are designed to work in a synergetic fashion. The effects and mode of action of the agents used are carefully balanced so not to over stimulate the body in a certain area. On certain days, the focus may be on anti-microbial treatments, on other days on detox support then again on optimization of the cellular terrain. It is important to work with your body and you will be monitored during treatment for any adverse reactions. Again, due to the careful combination of certain intravenous treatments and their synergistic effect, there are as good as no side effects.
If you have a port already implanted we can use it for the administration of most of the IVs. A PICC line may present a viable option when the patient is known to have veins that are very hard to locate or access. As the implant of a PICC line comes with a risk of infections we rarely recommend this alternative access. The INFUSIO® staff is very experienced in finding veins and using catheters. Also, in most cases we are able to leave the catheter in the vein for max. 3 days which helps to limit the amount of needle pokes to the arm.
No. Only certain medical problems are currently being treated at INFUSIO®. All patients need to be medically stable enough to have the treatment in our facility. There may be some exceptional conditions that may eventually be treated in hospitalized patients, but that remains for the future. Some patients may be declined due to the severity of their problem. Other patients may not have conditions appropriate to treat or may not be covered by our specialists or our protocols.
Yes. Patients with uncontrolled cancer are excluded. If you have an active infection anywhere in your body you must be treated first. Severely ill patients may require special consideration. Also, anyone with a bleeding disorder or who takes blood thinning medications requires special evaluation before consideration for stem cells.
The specialist seeing you at INFUSIO® will make a determination based on your history and exam, studies, and current research findings. Any complex cases may be reviewed by our ethics advisory committee. Occasionally, we may seek opinions from thought leaders around the world.
No. Participation in any of our protocols is not mandatory and there are no incentives, financial or otherwise, to induce patients to enroll in our studies. However, INFUSIO® is dedicated to clinical research for the development of stem cell science. INFUSIO® is taking an active role in cutting edge clinical research in the new field of regenerative medicine. Research studies will be explained and privacy will be maintained. Formal future research studies will be regulated by an Institutional Review Board which is an authorized agency that promotes validity, transparency and protection of human study enrollees.
Our fees covers Stromal Vascular Fraction SVF harvesting, preparation, and deployment. It also includes a 10 day supportive therapy program based on Philip Battiade’s Five Steps to Health. A preliminary cost estimate is sent to patient based on the information received and the therapy plan issued by the doctors. Any additional costs can only be determined after a medical evaluation.
INFUSIO® uses an integrative treatment approach based on the Five Steps to Health vs. just a single treatment modality. For sustainable health and long term healing it is important to use supportive therapies in combination with stem cells or other disease specific therapies. Our medical team will determine the best route of treatment with you for a therapy plan customized to your needs.
The body continuously produces healthy stem cells in the bone marrow. These cells are not affected by the body’s sick state. Chronic disease is believed to affect the body’s ability to mobilize the stem cells and have healthy cell-to-cell signaling. Extracting your own stem cells and administering them back to your body by an SVF cell therapy procedure can aid in reestablishing and optimizing these functions.
When is the ideal time to start the treatment program and what do I need to do in preparation of the treatment:
INFUSIO® practices foundational medicine and sets the stage for the stem cells to be introduced. In order to provide a healthy terrain for the stem cells a ten-day comprehensive supportive therapy program is administered. This is designed to bring the body in an optimal health state. Therefore, the ideal time to start can be at any given time. If you have a major surgery planned or you are recovering currently from an acute (not chronic) condition and your body is temporary out of its usual state you may want to wait until you have recovered for these.
The treatment will take a total of 11 days, Monday through Saturday for the first week and Monday through Friday for the second week. Typically patients arrive on the Saturday or Sunday before treatment to get settled in and are able to leave Friday on the last day of treatment or the following day.
Can I fly home right after my treatment?
It is important to get sufficient rest and give the body time to regulate. We recommend to book your return flight for Saturday if Friday is your last treatment day.
We do not recommend changing any of your current prescription medication you are currently on unless told so by one of the INFUSIO® doctors.
Patients usually feel great after the initial few days after the procedure as the SVF cell therapy contains a lot of anti inflammatory factors. This immediate response lasts usually 2-5 days. The following 100 days post stem cell procedure your body undergoes a so-called adaptive phase in which we expect a lot of activity and regulation being initiated. As a result, your body will retain a lot of energy for these processes, which in turn will make you feel tired at times. You will also notice that your current symptoms may be amplified at times but you will also experience days in which you will get a glimpse of your healthy state. The end of the 100 days, mark the peak potential of the stem cell replication and activity. This does not mean that all processes are finished. On the contrary, at this point we are able to assess the progression of the regulation processes and which areas the body has been addressing. Healing processes especially related to nerve issues can take up to 12 months or longer.
Our medical team recommends an anti-inflammatory diet such as Paleo, Bulletproof or Low FODMAPs.
In preparation of the treatment we recommend an anti-inflammatory diet. We also recommend considering a psychologist support for the healing phase as well as establishing a healthy family and friends support group around you that can help you through your healing journey once you are back home.
The liposuction procedure is minimally invasive and lasts no longer than 20 min. Usually fat tissue is extracted from the side of your waistline. Two small incisions are made under local numbing. Saline along with more local numbing medication is flushed through this incision into the underlying fat tissue. After waiting for the numbing to take effect, a small amount of fat is removed using a fat harvesting needle. This process may cause some discomfort, but, in all, is relatively painless.
Various deployment methods can be used depending on the condition that is being treated. Generally the SVF solution is administered via an IV. Local injections into the abdomen, joints or facet joints may be used as well to deploy the stem cell locally. The medical team will decide which method may apply and be viable in your case.
Different conditions are treated in different ways and there are different degrees of success. If the goal is regeneration of joint cartilage, one may not see expected results until several months after treatment. Some patients may not experience significant improvement and others may see dramatic regeneration of damaged tissue or resolution of disease. Many of the disorders and problems that the physicians at INFUSIO® are treating represent pioneering work and there is a lack of data. FDA regulations prevent INFUSIO® from making any claims about expectations for success, however, if you are chosen for treatment, it will be explained that we believe stem cell therapy may be beneficial or in some cases that we are unsure and treatment would be considered investigational.
Stem cell therapy relies on the body’s own regenerative healing to occur. The regenerative process may take time, particularly with orthopedic patients, who may not see results for several months. In some diseases, more immediate responses are possible.
The clinic is located at Zum Laurenburger Hof 76, 60594 Frankfurt, Germany
INFUSIO® is able to provide a list of local hotels in the area, though most patients prefer to stay in an Airbnb.
While you will be seeing many specialists during your stay, the cell therapy programs are overseen by one doctor. This doctor is also responsible for the fat extraction procedure and oversees the stem cell processing. For more information on the team of doctors and their bios please visit the location specific website.
Phil studied medicine in England; he has a degree as a naturopathic doctor in Germany. This allows him to practice multi-disciplinary. He has additional certificates and diplomas in biological cancer therapy, ozone therapy, chelation therapy, hyperthermia, SVF cell therapy, sonographic imaging and orthopedic sonography. He is McKenzie trained and studied tropical medicine. He also trained with neuro surgeon Dr. Andrews performing the first DBS surgery in West Africa. He also contributed to the publication “Basics of Blood Management”.
Phil does not practice medicine or see patients in a doctor’s capacity in the States. He is INFUSIO®.s founder and trains doctors globally in the INFUSIO® concept. He also consults for his practice in Germany.
The following arrangements are in place to provide our patients with the best follow up care possible:
-INFUSIO® has a follow up phone call routine in place to make sure patients are regularly checked on after they leave us.
-Before patients leave the medical team conducts an exit talk to brief them what to expect during the next hundred days.
-During their stay at INFUSIO® patients are given instructions on diet, follow up and the dos and don’ts after stem cells before they leave.
-A physical follow up appointment is scheduled after 100 days. At this appointment usually a Global Diagnostics follow up scan is performed and a hormonal panel or other necessary blood work may be ordered. This follow up appointment helps to assess where things are and how the patient is progressing as it marks the peak potential of the stem cells.
-Our main phone number 888 605 6579 can be used for patients to call within normal business hours.
-The email email@example.com is dedicated for INFUSIO® patients to send us any questions they may have.
-Research study questionnaires are being sent out on a regular basis to collect data after your stem cell therapy. This program lasts for 5 years.
-INFUSIO® organizes a weekly Facebook Live Q&A with Philip Battiade where patients are able to post questions.
It is a major undertaking that requires good organization on our end but also patient compliance on the other end.
INFUSIO® performs SVF cell therapy and specialize in foundational medicine. We are happy to answer questions related to the therapy. For some issues and health concerns we may not be the right point of contact though. Your primary care physician may be able to help you better with some immediate symptom relief or short term medication. In case of an emergency, please call 911 and do not hesitate to admit yourself to the ER.