Biocellular Regenerative Medicine®
“Using Your Own Tissues to Heal”
What is Biocellular Regenerative Medicine?
The term “Biocellular” refers to the combination of important biological chemicals (such as growth factors, signal proteins and chemicals important to wound healing) & the primitive "undesignated" cells within our body which participate in tissue repair and regeneration. Science and Medicine have entered into what is termed “translational medicine” where proven laboratory science has demonstrated important contributions and joins the clinical application of the science in humans. There has been much controversy concerning the use of “stem cells” in the current practice of medicine. Unfortunately, this usually is interpreted as being “embryonic” or fetal stem cells, implying destruction of embryo’s or fetus tissues. WE USE ONLY ADULT CELLS!
What is used in Biocellular Regenerative Medicine at this time is limited to a person’s own ADULT (non-embryonic) cells capable of participating in healing and regeneration. Derived from your own tissues (usually adipose (fat) tissues or bone marrow aspirates), the small nucleated cells found closely associated with the small vascular tissues are now recognized as serving important roles in maintaining normal tissue content (homeostasis) PLUS have the ability to respond to injury or disease processes in a constant effort to heal or repair damaged cells (as in aging, arthritis, musculoskeletal tissues, neurological disorders, etc.). The remarkable design of the human body uses these reservoirs of available, non-differentiated cells as the first responders in the situations of major or micro-trauma and aging. By secretion of certain chemicals from an injured site, these multipotent (i.e. can become various types of cells) cells can be called upon to participate in the repairs needed to restore tissues and functions. We will explain the cells involved in this process in the content of this information
The “biological” components refer specifically to the need for a variety of growth factors and signal proteins which interact with the cells of the injury or damaged site to help recruit needed repair cells and materials to repair the area. There are two major “biological” components in common use at this time. First, is using contents of platelets, whose most important role is not in clotting, but rather to serve as a "storehouse" which contain and release a wide variety of needed growth factors and proteins capable of acting on available cells in a damaged site to both start and maintain the entire wound healing processes.
For many years, we thought the only important roles of platelets (PRP) were to become “sticky”, adhere to each other and participate in clotting mechanisms. We now realize that this may be their LEAST important contribution to wounds and wound healing. Platelets represent a storehouse of small granules, which release these important growth factors and signal proteins that serve to “quarterback” the entire healing cascade, and do this for a prolonged time during the healing phase. For example, an important chemical available from these granules are essential for blood vessel replacement and repair in order to improve the circulation ability critical to healing of all wounds. Without adequate blood flow, needed oxygen cannot reach the area of damage, nor permit migration of a variety of cells from nearby and far cell sites.
The second source of biological contributors are found in bone marrow aspirates. Bone marrow has been used for many decades, and are in common use in blood related disorders. Although bone marrow does have some undesignated cells (stem/stromal cells), they are in very small numbers when compared to fat tissues. In order to become a cell contributor, it is required that bone marrow aspirates must be isolated, concentrated, and cultured (expanded) in order to achieve meaningful numbers considered essential in regenerative and healing applications. In addition to these more rare cells, however, is a very large store of hematopoietic stem cells (blood forming cells) and many platelets. When combined with the adipose stroma, bone marrow is primarily of value for the ability to provide concentrated platelets, and can be used as discussed in the previous paragraph as an important additive to cells to work together to provide optimal healing conditions and abilities. Many prefer to avoid the costs, discomfort, and invasive risks of doing bone marrow aspiration
Understand the “Workers and Bricks” analogy:
A simple analogy is helpful in understanding the importance of both the biological and the cellular elements to achieve more rapid and complete healing and repair. As an example:
If you have a brick wall that is beginning to break down, some of the mortar holding the bricks together is lost or crumbling. What is needed to repair the wall would be hiring WORKERS to come in, clean up the site, and repair and replace the damaged mortar. Once completed, the wall is repaired and functions as originally intended. These workers are found in great quantities in platelet concentrates, and comprise the “biological” contribution of the Biocellular Regenerative treatments.
In the event, however, that your wall is not only losing mortar holding the bricks in place, imagine if you have lost or broken many of the bricks in the wall. This would require NOT ONLY the ‘workers”, but would also require “BRICKS” to replace the lost and damaged ones. The “bricks” in this analogy come from the cellular source (fat tissues). It is now very well established that there are many more of these undifferentiated cells located in the largest micro-vascular organ of your body, the adipose (fat) matrix. Therefore, the readily available and safely accessible “cellular” contributor of choice has become adipose tissue retrieved from subdermal fat deposits in the abdomen and thigh areas. These are gently removed via closed syringe lipoaspiration, compressed by centrifugation, and mixed the platelet concentrates (>4-6 times your own circulating platelets) to form the therapeutic mixture known as “Biocellular Regenerative Matrix”. Lipoaspirations (suction) have been done for more than 30 years in Aesthetic Surgery, and has an incredible safety record.
This mixture is in current use in aesthetic (plastic), reconstructive, sports & pain medicine, orthopedic medicine and surgery, neurological disorders, musculoskeletal and arthritic applications, and a wide area of overlapping disorders.
What are “adult stem/stromal cells”?
These are a diverse group of “non-designated” cells found throughout the tissues of our bodies. They serve as a reservoir of replacement and repair cells, which react to injury, aging or disease. “ADULT” cells in this category are often referred to as “stem/stromal cells” or “stromal” cells, and should be clearly separated from embryonic cells. They are also called “progenitor” cells, which means they have the capability to differentiate into different types of cells, responding to growth factors and signal proteins within the site where they are located.
For example, if you have a muscle or ligament tear, these cells might participate in healing or repairing the damage providing replacement muscle or ligament tissues, rather than turning into scarified tissue. Scar tissue is not as functional or tolerant of future stresses, and is NOT the ideal goal in wound healing, contributing to re-injury or tearing under "load". By providing the needed elements to such a site, the body is given the opportunity to fully repair damaged areas, often by cellular and biological events.
There are many experiences in such cases over the past 7 years in the musculoskeletal area, and for nearly 20 years in aesthetic surgical practice. These are often reported on small case series or case reports of treatment and outcome, and are being further studied in many clinical trials. These trials include both guided placement of stem/stromal elements and biological agents in orthopedic medicine and surgery, but also intravenous and intrathecal placement in a variety of complex disorders which do not respond to conventional therapy (such as diabetes, multiple sclerosis, altzheimer’s disease, parkinson’s disease, severe limb ischemia (loss of blood flow), etc.). Early reports of improvement in chronic conditions, including arthritis are driving many to select this option to improve surgical outcomes or avoid surgical interventions and shorten the demands for physical therapy.
Many are confused about the potentials or best source of stem/stromal cells, often believing this only refers to use of embryonic tissues. In the past 10-15 years, much evidence has led us to understand that your own fat may be an ideal source of needed cells, avoiding the need to destroy fetal or embryonic tissues to acquire cells of great potential.
With the ready availability, minimal invasive access (using closed syringe lipoaspiration for example), and long-term safety profile, fat has become an optimal source for these cells. Fat is the largest micro-vascular organ in the body, and as such, have become well recognized as the largest depository of undifferentiated stem/stromal cells in the entire body.
All cells reside in tissue micro-environments, where they comprise tissues and organ systems. These are also called “niches”, and are the locations where injury or disease must be addressed to permit the body to repair or regenerate itself. It is believed that when that process is underway, addition of needed cell types and biological elements specifically targeted (via ultrasound guidance for example), can effectively utilize your own tissues to heal themselves.
What is involved in Biocellular Regenerative Therapy?
First, the platelet concentrates are created in an FDA approved, sterile, closed device from a peripheral blood draw (like you have when your physician tests blood). Thousands of patients have undergone treatments using these concentrates with quality results in many inflammatory or aging conditions.
Next, the CELLULAR sample is harvested from subdermal fat deposits under sterile protocols, using the FDA approved and patented closed syringe system for minimal tissue disruption. This is often referred to as "microcannula liposuction" or harvesting. This fat is cleaned, compressed and unwanted liquid separated by centrifugation. This process not only helps with removal of unwanted liquids, but also compresses the adipose cellular components to provide a more effective cell and bioactive matrix. BIOLOGICALS, such as high-density platelet concentrates are then added via closed syringe transfer to create a mixture of cells and the important growth factors and signal proteins provided by the concntrated platelets (known as HD PRP).
In some cases, a portion of the fat is separated into another syringe, exposed to digestive agents, warmed and shaken to permit further isolation and concentration of the mononuclear undifferentiated cells gathered. This is termed “cell-enriched”, and the isolated cells are simply added back to your own adipose tissue, mixed with HD PRP, and carefully guided into identified target sites to assist your own tissue healing using only your own tissues. This is commonly performed in many areas outside of the United States, but at this moment, the FDA regulations prohibit the addition of the digestive chemical. Many sites are able to provide these services in the United States, but are completed within controlled Institutional Research Based (IRB) studies. We are currently offering both options within the United States following International Cellular Medicine Society (ICMS) IRB guidelines plus providing the full protocols in accredited sites outside the continental United States.
Who should consider having Biocellular Regenerative Treatment?
If you and your doctor (e.g, primary care health care provider, orthopaedic surgeon, sports medicine specialist, pain management specialists, wound care centers, etc.) believe you have a condition which has good potential to be improved through use of biologic or stem/stromal cellular treatment, we can coordinate a procedure specific to your needs. Once you, or your Doctor, recommends exploring Biocellular options, we establish a consultation which permits history, physical examination, diagnostic evaluation with MRI or high definition ultrasound studies, and treatment plan formation. Routine appointments are then arranged to provide treatment by qualified, licensed providers at the appropriate medical-surgical center serving your case needs.
In addition to providing the guided Biocellular Regenerative treatment, we carefully document your specific treatment, provide appropriate follow up examinations and enter the data into a confidential database which will only be used to provide evidence of clinical outcomes using these procedures. As they are termed “translational” at this time, this data will directly contribute to scientific basis and testing needed to contribute to “evidence-based” studies for future patients.
It is very encouraging after several year’s experiences globally that use of the Biocellular Regenerative protocols represent one of the newest and most exciting advancements within Medicine. We are actively documenting and publishing case data which evaluate the safety and efficiency of such treatments. Since these ONLY use your own cells and DNA tissues (termed “autologous”), there cannot be “rejection” or contamination from any other individuals.
In our Affiliated Centers, we use approved equipment and devices in order to acquire, prepare, and administer treatments using sterile and safe conditions. It is typical to meet with one of our licensed physicians to have a full review of your health records, undergo examination and treatment planning. Assuming you are a good candidate, the procedure may be scheduled and any needed laboratory work or medical clearance deemed appropriate in your case will be requested. Important detailed instructions will be provided (verbal and written) to you prior to your scheduled treatment.
Many times these procedures are completed under local anesthesia, nitrous oxide, or light sedation depending on your needs and desires. This will be decided on the date of your formal consultation. These cases are designed and planned to be completed within the same day. Your tissues will be carefully handled under sterile conditions and prepared for guided placement to the areas of concern. In the event you are selected as a candidate for the “cell-enriched” procedures in one of our International Institutes, you will harvested in the morning, and by afternoon the preparation will be available to complete treatment. Cell-enriched treatments are currently termed: "Biocellular Regenerative Medicine PLUS"
How much do these treatments cost?
Within the United States, and compliant with current regulatory FDA guidelines, these treatments are offered on an outpatient basis in a single visit. Typical costs ranges from $2500-$5000 USD depending on the recommended treatment suitable to your area(s) of concern. This requires a scheduled diagnostic appointment after you provide your medical records (physical, surgical history, reports of MRI or CT scans, etc.). You will be professionally examined via physical examination and high-definition ultrasound to fully evaluate your situation and confirm your candidacy for having Biocellular Regenerative Treatment.
Internationally, medical “tourism” is becoming very common. This means that in the event you select use of the cell-enriched options, you will need to travel to a licensed and approved Affiliated Hospital facility for treatment. There are multiple centers in Asia and Europe that offer these types of treatment, often with very high costs. Some of these often require cell culture and expansion to achieve enough cells, and involve much longer term stays on location than with the Biocellular Regenerative treatment and are much more costly due to having to stay up to one month at the location or make two trips to complete your treatment.
We offer a MUCH less complicated and time consuming alternative. We now provide Biocellular Regenerative Medical and Cell Therapy within the continental United States & in our affiliated clinic in Roatan (HN) (in Western Caribbean). Cell Therapy is being offered in Institutional Review Board (IRB) studies within the United States in the Caribbean Countries, Europe, Asia, South and Central America. Today, advanced Cell Therapy & freeze storage (cryopreservation) is also offered in one of our International Institutes, an additional outlet about one hour South of the United States on Roatan Island. Costs vary according to case and problems, and typically are accomplished on the same day, allowing for much shorter stay requirements. This savings for avoiding two travel sessions, or waiting long periods of time outside the country, are much less complicated and expensive. Unlike the more expensive bone marrow harvesting and requirement for culture expansion, we do not require two trips to the destination in order to treat you. Typically we anticipate approximately a 2-3 day stay, which would include the time for evaluations, performance of the minimally invasive procedures, and follow up after treatment the following day.
You will be provided an estimate prior to scheduling, and an exact one following examination. We will make every accommodation possible to arrange a mutually acceptable appointment and treatment date. We request routine follow ups and tracking, and will keep you apprised of your progress. This monitoring of your personal situation will help us determine your return to normal activity and function. Our group of doctors and staff have extensive experience with such treatments, and will do everything in our power to provide you will the safest and highest quality care possible. Your decision to have Biocellular Regenerative treatment will need to be made between you, your family and doctor, understanding as in any medical procedure no specific guarantee of success is possible. Using your OWN tissues to help heal yourself is a major health care paradigm change, and is one of the most exciting minimally invasive options currently available.
We look forward to answering your questions. Please click on the Contact Us link on the website to submit your information or specific questions.