Dr. Berman talks about his research in fat stem cells.
Most people (doctors included) believe that stem cell therapy is still several years away from being available to the public. However, since 2010, in association with my partner, urologist Elliot Lander, MD, FACS, we have been conducting stem cell deployment as part of an ongoing investigative project collecting data on thousands of treated patients. After several successful outcomes in the orthopedic arena that I obtained in collaboration with orthopedic surgeon, Dr. Tom Grogan, Elliot and I formed the California Stem Cell Treatment Center followed a year later by the Cell Surgical Network – the world’s largest network of stem cell physicians utilizing technology we developed with renown Korean plastic surgeon, Dr. Lee Hee Young. We currently teach doctors from the USA and worldwide our techniques using the CSN Time Machine® to effectively harvest and process fat into stromal vascular fraction (SVF) rich in stem cells. Starting with a 10 minute mini-liposuction painlessly done under local anesthesia, this 1 ½ hour process has yielded results that have been successfully recapitulated all over the world. Currently, there are about 100 CSN centers in the US and many more throughout the world, including dozens in China in association with our partners, RE Stem Biotech.
We are now in a new era of medicine. Our bodies are made up of dozens of trillions of cells. Up until now, medicine was predominantly aimed at keeping our cells healthy and alive through diet, exercise, medications to eradicate disease, or supplements to help our cells stay healthy, but now, going forward, we have the opportunity to replace injured or dying cells with our own DNA coded stem cells. These cells can not cause an allergic response or be rejected. While many people consider this experimental, we really consider it investigational but not really experimental. This may be a NEW era in medicine, but it really reflects perhaps the OLDEST form of intervention. Before we had any kind of medical intervention we had to rely on our body’s natural cell defense to keep us healthy. We now have the ability to unlock and harvest huge quantities of these repair cells for immediate use and, further, we can send samples to our lab where they can be cryopreserved and expanded as millions of stem cells for later use. Indeed, we have coined the term CRT – Cell Renewal Therapy – to describe how we foresee the future of medicine whereby your natural “spare parts” in the form of your own DNA cultivated stem cells will be made available to keep your body healthy and extend longevity for years beyond anything ever imaginable.
Stem cells are basically unspecialized cells that can replicate and differentiate (i.e. turn into other specialized cells). They tend to have three basic properties: 1) anti-inflammatory; 2) immune-modulatory and 3) reparative or regenerative. Most people think an embryo is the most common source for stem cells. While most stem cell studies started by using embryos, there are a number of issues and problems associated with their use. Not only are there ethical concerns, embryonic stem cells can sometimes form tumors (i.e. teratomas).
There are also a lot of stem cells naturally found in our body. Most people are aware of bone marrow derived stem cells. In recent years, bone marrow has been a source for stem cells particularly for orthopedic conditions. However, stem cell yields in bone marrow tend to be between 50,000 and 200,000 with some of the newer technology. Adipose (fat) tissue also houses vast quantities of stem cells. In fact, just 30 cc’s (2 tablespoons) of fat can yield between 10 and 30 million stem cells.
Our fat derived stem cells have a tremendous capacity to turn into a large variety of tissues. Originally, because of their “mesenchymal” origin we thought they could only turn into fat, cartilage, bone, muscle, connective tissue, blood vessels and nerve tissue, but now we have studies showing they’ve turned into practically every kind of cell in the body. While the “bone marrow” proponents will sing the virtues of bone marrow stem cells for cartilage repair, it turns out that fat derived cells are an even greater source for cartilage repair and production. Compared to a bone marrow harvest, it’s so simple to harvest a little fat and the yields are generally very high making fat an ideal source for stem cells.
When we started our studies in 2010 the critics suggested it might not be safe. Our initial study made SAFETY the primary objective and the clinical outcomes a secondary objective. Our safety study of over 1500 patients has shown that there are no significant adverse events related to the deployment of SVF. Indeed, the only real issues have been some mild discomfort around the liposuction site – something we naturally expect. We’ve submitted this paper for publication.
While there are a growing number of doctors claiming to provide stem cell treatments, we believe the most ethical approach is to do it under the umbrella of IRB approved research protocols. An IRB is an Institutional Review Board or an organization of members responsible for approving and overseeing research on humans. IRBs are approved under the auspices of the U.S. Department of Human Research Protection. As such, our patients understand the investigational nature of our activities, are provided appropriate informed consents, and are followed continuously on an online database to chart their progress or any issues of concern. This will allow us to not only accumulate safety data but demonstrate effectiveness of treatments and help us to improve treatment programs going forward.
We already have a number of very innovative treatments in progress. For example, one of our approved studies involves deployment of cells via an Ommaya reservoir. This is a device that connects a port under the scalp via a tube directly into the ventricle of the brain where cells can be added to the cerebral spinal fluid. This concept evolved by working with renown Brain Surgeon, Christopher Duma, MD, FACS. It was preceded by safety studies on laboratory rats and 30 patients later is showing some significant progress.
As you can imagine, with “new” technologies, patients often come to you when they’ve exhausted most other traditional treatments. We’ve now had a lot of experience to understand how well cell therapy can work even though we’re continuing to gather data and look for ways of optimizing treatments. So, for example, most patients with arthritic knees will consider stem cell deployment after they’ve tried pain medication, steroids, hyaluronan injections and even arthroscopy. None of these are actually treatments that repair the problem but rather mask the pain or temporize the situation. If there’s cartilage in the knee then it can potentially signal your stem cells to repair the joint. We now understand that acute injuries probably respond better than chronic ones because there are more messages (cytokines) directing and instructing the stem cells into action and repair. Still, until we have enough data and publish enough articles to support these positions our concepts remain “conjecture” awaiting to be proven.
Patients are also concerned about whether these procedures are FDA approved. Technically, the FDA only approves drugs and devices. We’re actually performing a surgical procedure and the FDA does not approve surgery. However, we are working with the FDA to have our system evaluated for potential FDA approval. Our initial FDA studies will be aimed at knee arthritis with the goal to show autologous SVF is more effective than a placebo. This will be done with a “double blind controlled study.” I doubt we will do FDA studies for every potential condition rather, doctors will ultimately gather data and/or do their own research and accumulate results to support the positive use of SVF for a large host of inflammatory and degenerative conditions.
Since starting our investigative network in 2012, we’ve not only gone to the animal lab for the Ommaya reservoir program, we’ve expanded our research into areas of cancer, paralysis, and most recently, concussion. My son, Sean, in fact, has been doing some terrific animal research in the area of concussion where he’s been able to first, induce reproducible concussions in trained animals and show that they generally take two weeks to get better and re-learn their memory and motor skills; and second, by giving SVF via a tail vein injection after concussion, the rats get better so quickly that they regain their memory and motor skills right away. The implications for athletes, football especially, and the military are extraordinary.
There is a lot more information about our program that can be found at our website – stemcellrevolution.com. Still, while this currently remains an area of investigation, it also represents one of the most exciting transitions in the field of medicine with tremendous potential now and in the future.
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