Biocellular Regenerative Medicine
Information about "Biocellular Regenerative Medicine":
Regenerative medicine is an evolving new field of medicine, which may enhance a patient’s own healing mechanisms to induce therapeutic results. Over the past 30+ years, injection therapies have increased and improved. Originally, procedures known as "prolotherapy", was performed with use of injections of concentrated dextrose into damaged tissues led to stimulation of inflammatory capabilities and often improved the sites. Next, use of platelet concentrates (PRP) were injected into wound and injury sites to take advantage of the important healing factors contained in platelets.
Now, there are advances that suggest these precise guidance into damaged sites can be improved with use of adipose-derived stromal vascular fraction elements may also participate in directly stimulating the wound healing processes, PLUS, may provide needed cells that have the ability to change into the types of cells to actually repair an injury site (shown in tissue culture, in vitro). This group of cells are commonly referred to as "adult stem-stromal cells", and are found in bone marrow and fat deposits, and essentially every tissue and organ in our bodies. These tissue-based cells, and blood-based contents of platelets have been concentrated and very carefully placed via guided ultrasound directly into many tissues (like wounds, surgical sites, ligaments, tendons, muscle, joints, nerve injury, etc. to amplify the healing capabilities and lead to repair and return to comfort and function. Note, that these are taken from an individual and returned to that individual (known as autologous tissue), and have nothing to do with use of embryonic stem cells or use of any other person’s tissues, cells or perinatal liquids.
Basic understanding Of Adult Stem & Stromal) Cells:
The adult "progenitor" (Stem and Stromal) cells are found in fat, bone marrow, and, to a lessor extent in muscle, skin, and every organ of the body. Our body uses them for self repair and maintenance of our tissues. Without them, we would not be able to heal a wound, repair a fractured bone, maintain working organs, or a myriad of other basic functions. These undifferentiated cells are concentrated around our extensive blood vessel networks, and can be called upon in times of injury and damage, such that needed fibrous, muscular, neurological, fat, bone and cartilage to change into the types cells needed to heal the site. The signals that decide what cell type is needed come from damaged tissues, and can be amplified by addition of platelet concentrates which contain the major growth factors and signal proteins. This activates, recruits and stimulates cell change (differentiation) to control the healing processes. As previously described, for many years, platelets were recognized as important in helping clot bleeding areas, but are now known to be much more important, serving to control the entire series of inflammation and healing changes we know as “wound healing”.
Through many scientific advances, we now have the ability to separate and concentrate the cells from various areas, and carefully targeted (ultrasound) placement is rapidly gaining experience and offering help, many times in cases which have no other options for cure, or inadequate medication (drug) improvements. The safety and potency of using a person's OWN tissues is showing encouraging recovery or repair, and delivery does not expose patients to allergic reactions to the cells since they are of the same person (self). These are the SAME cells that we sometimes consider as an option for use daily in maintaining our body's health, and repair in cases of injury or degeneration with age.
The cells are important, but they are not the only reason that the changes and improvements have been reported in peer-reviewed medical publications, and seen as a VERY important factor in the actual secretions made from these cells which are important to recruit and secure needed healing or repair components and influencing many different kinds of cells. This effect is known as "paracrine" effects, and which are now believed to be the most important of all factors in cellular and biocellular interactions in healing, maintaining, and repair within our bodies throughout our lives. Some published studies suggest that the impact may be widespread if given in a vein, but most are felt to be potentially more important when placed locally, as a very powerful influence on your own healing and repair. Through very small particles associated with these cells, tiny structures known as exosomes and microvesicles are felt to be the way in which these cells influence many cells and tissues requiring the information to initiate the regenerative processes and cause the repair processes to increase. This, in turn, directly impacts your own body to respond and react to the needed regenerative effects. Much research is being done at this point in time, and more detailed information is streaming to us at a very rapid rate. Regulatory changes are developing such that standardization, safety and efficacy from FDA and its agencies. So far, primary Regulations are in the form of "Guidelines" at this time.
Mechanisms Of Action For Stromal Vascular Fraction & Platelet Concentrates:
In review, when there is an open or surgical injury, one of the first responses is the attraction of platelets, the blood component that is responsible for clotting. The platelets “plug” the hole, if there is bleeding. After the bleeding is stopped, they begin to release important compounds held inside them in structures called “alpha granules”. These granules provide powerful growth factors and signal proteins (cytokines) which target undifferentiated cells to begin to activate and change, or recruit other cells critical to healing the particular site.
As an alternative to traditional surgery or drug uses, is the combination of stromal vascular fraction (usually taken from subdermal fat) with, or without, platelet concentrates, may be placed under high-definition ultrasound guidance directly into the areas of identified damage. Once placed, the components enter into the actual “micro-environment” of injury and become active to believed to help the site begin to heal itself without requiring open surgical intervention and shorten the required rehabilitation period and therapy. This combination is also often recommended in areas of previous surgery which has incompletely healed, and to precede the plan for necessary open surgery to prepare the site for maximal response following surgery.
These therapies are still considered investigational, with more than 15 years of use and clinical reporting in respected medical journals and books. For this reason, Medicare and some third-party insurance carriers are hesitant to provide coverage, preferring to make it the patient responsibility to reimburse for the treatments. Thousands of such treatments have proven the safety and effectiveness of this form of regenerative therapy, using a patient’s own tissues to help in the healing processes. Some private insurance and State operated coverage is evolving at this time, mostly waiting on creation of a national insurance "code" which permits for specific site and treatment coverage of this type.
Patients have been treated for a wide variety of musculoskeletal problems, ranging from needs of padding, (scaffolding, degenerative changes, etc. (plantar faciitis, tendon, ligament, joints ;ike shoulders, elbows, hips, knees, ankles, neck-back, etc), muscle, and scar limitations of range of motion. In addition, it is well proven as effective for filling contour irregularities or augmentation of lost structural fat, nerve pain problems, and in skin trauma and chronic wound healing situations for decades within Plastic & Reconstructive Surgery..
How is this done on me?
As previously outlined, first, an accurate evaluation and diagnosis is completed by detailed history, physical examination, internal evaluations (X-ray, MRI, CAT scan, High-Definition Ultrasonography, etc.), and review of records of surgical care (if done). Based on a combination of these findings, a treatment plan is developed for each individual case and situation. This treatment plan may include traditional medication treatment, open surgical interventions, or alternative methods of addressing the specific issues each patient may have.
If no other traditional methods have proven feasible or effective, if the patient does not want open surgical intervention, and physical therapy not improving, then alternative methods may be indicated and recommended. Previous discussion of how small disposable cannulas (tubes) are used to acquire the SVF and blood draw to concentrate your platelet may be recommended.
Providers using these alternative methods In the early post-treatment period, often recommend to avoid use of anti-inflammatory medications (such as Mobic, Meloxicam, Aleve (Anaprox), Rolafan, etc.). Use of these drugs may slow or limit your ability to fully heal the problem area. Use of Advil is permissible, and recommended to take two (200 mg over the counter) motrin/advil 3-4 times per day. At this time, only the Advil products have been examined in tissue culture (low dose) to not interfere with the proliferation and, presumably, effectiveness of this combination.
You will be provided a general outline of post-treatment care. As part of this process, you may be asked to carefully move the involved areas in order to limitedly maintain range of motion and weight-load of the problem area(s). No casting or splinting is typically required, as wound healing under controlled work load is considered important to accomplish a full recovery. In some cases, use of moist, cold compresses to the treated site is recommended, which may help reduce swelling and limit some post-treatment discomfort. In addition, later in the process the patients may be asked to use a moist electric heating pad (low to medium settings) to help with the reduction of swelling and encourage circulation. Patients often are asked to carefully “listen” to their body, and avoid excessive or potentially harmful activities in the early post-treatment period.
In some more complex or extensive post-surgical cases, it may be recommended that a supplemental treatment may be of value in the 6-12 month timeframe to further enhance the final wound healing processes. This is often true in the more extensive or multiple sites which are not treated at the same time cases (example: if bilateral foot or knee problems, often have to split the treatments into two separate sessions to allow for a degree of normal ambulation. Secondary treatments may involve only the use of platelet concentrates only, or our treating Physician may recommend PRP and progenitor cells within your fat. Reportedly, secondary treatments are often less bothersome in the post-treatment period than the first time.
These cases are usually performed on outpatient basis, under local anesthesia, with good tolerance remembering the sites treated are often already somewhat painful and inflamed prior to treatment. Oral pain medication is often prescribed to help for the first 2-3 days of discomfort, and some oral sedation for anxiety or and reduction of reaction to guided placements.
Most patients have some degree pain with this procedure, but this is minimized with local anesthesia and mild sedation, if needed. Because this treatment is directed to areas that may be painful, there is often discomfort for the first 2-3 days. For many patients, this is minimal. It is normal to have intermittent tenderness off and on for the first few weeks and after heavy use of the problem area. This is not typically as much compared with open surgical procedures and during the prolonged or uncomfortable rehabilitative process.
Known Risks or Complications: Very Uncommon Incidence
Incidence of complications are considered relatively rare, but as in any medical or surgical procedure they are possible. Although wound healing may be enhanced, it remains out of either the physician OR patient control. It is considered very important to carefully follow the verbal and written instructions to optimize your care and safety. As in ANY medical or surgical option, there cannot legitimately be promised outcomes or success provided by reputable practitioners.
1- Allergic Reaction: This would be Reaction to local anesthesia, latex, or tape adhesive or medications in most cases.
2- Infection: This risk is very low, and the procedures are done under standard sterile surgical skin preparation, isolation and sterile protocols. There is a extremely low risk of infection, and only patients with artificial joints or heart valve/stents are usually prophylactically covered with antibiotics.
3- Excessive Bleeding or Clot Formation: Very unlikely, and no known report of hematoma formation in use of the microcannula system.
4- Irregularity At Fat Donor Site: Very unlikely due to small volumes (usually only 4-8 teaspoons) needed and to our knowledge has not been reported as a common factor in micro-lipoharvesting procedures the current medical literature.
5- Fat or Blood Embolism: Extremely unlikely events, patients are often ask to continue taking a “child’s” aspirin (81 mg). At this dose, aspirin will not materially impact the inflammatory processes. to our knowledge, this has not been reported using micro-cannula use in the Aesthetic Plastic Surgical or medical-surgical literature at this time.
6- Incomplete Improvement Of Problem: Although many patients are significantly helped, complete wound healing is not within the control of the patient or the physician, therefore, no promises or guarantees can be given
7- Worsening Of Condition: This has been extremely unusual, and is thought to be a subjective patient response, or, advancement of disease or injury processes.
8- Temporary or Permanent Injury To Nerves: Any injection may injure nerve structures in the path of the needle used to inject, however, use of Ultrasound and Doppler in use to avoid this issue. This is typically transient, with gradual improvement over time and healing.
9- May Not Eliminate The Need For Open Surgery: Even if invasive surgery is required after regenerative therapy, often patient’s outcomes are believed to be improved based on more effective healing response.
10- There is almost always at least some temporary discomfort or occasionally significant pain following treatment, and appropriate medication can be prescribed.
11- If sedation is used for the procedure, the risk of sedation (very rare) and reactions to these medications is possible.