Regenerative Medicine: Stem Cell Injections
Regenerative Medicine: A New Approach to Old Problems
Regenerative medicine is a burgeoning new field where cells from one place in your body are harvested, concentrated and used to repair damage or cure disease in another part. Currently the active cells of interest that are harvested are commonly known as stem cells. This more natural way of repairing damage and curing disease does not rely on medications or surgery.
What are Stem Cells?
Stem cells are found in many places in the body in varying amounts. They are cells that haven’t quite decided what they want to be when they “grow up”, undifferentiated cells that under the right stimulus can turn into a variety of well differentiated cells such as a muscle cells, bone cells, cartilage, blood cells, etc. The cells we use for regenerative medicine treatments are adult stem cells that reside in the fat where there is a particularly high concentration of them. When we treat a patient with stem cells, we use the adult stem cells derived from his or her own fat. Because they are the patient’s own cells, they are termed autologous and as such there is no rejection of them or any allergic responses. Embryonic or fetal derived stem cells are not autologous and we do not use them.
What Do Stem Cells Do?
While we don’t know the whole story entirely, there is good evidence that injected stem cells along with the other cells that accompany them, home in on areas of inflammation and damage and initiate tissue repair. We highly suspect that when stem cells are injected into an arthritic joint, they not only reduce inflammation, but also turn into new cartilage forming cells. There is also good evidence that stem cells injected intravenously can mitigate certain systemic diseases. They have been used with some success on people suffering from a variety of chronic neurological diseases such as Parkinson’s disease and multiple sclerosis and other chronic arthritic and autoimmune disorders.
What Types of Diseases and Problems Are Treated with Stem Cells?
Stem cell injections into osteoarthritic joints such as the knees, elbows, shoulders, hips have shown to be very effective. Patients with variety of chronic neurological, autoimmune, rheumatological, gastroenterological diseases have benefited from stem cell injections, sometimes dramatically so. We carefully assess each patient on an individual basis before recommending and undertaking stem cell injections. Again, there is no evidence to date that stem cells cure any disease. However, as the results to date have been encouraging, likely, more and more physicians will try to treat many different diseases and problems with them.
Who Have Been Shown to Benefit the Most from Stem Cell Injections?
Probably the most common condition that has been treated with stem cells and the one that has done the best is osteoarthritis or “wear and tear” arthritis of the joints, particularly the knees. Those who have tried everything for their knees and still have pain, for whom the only treatment left is surgical knee replacement, have experienced the best results with stem cells. Of course, the more advanced the arthritis is, the less improvement with stem cells. Other joints such as shoulders, elbows, hips have also shown excellent improvement. The results of stem cell injections on chronic systemic conditions have been variable. Some patients with fibromyalgia and multiple sclerosis have seen good improvement in their overall condition with these injections. There just aren’t any long-term multicenter double blind placebo studies to date examining whether or not stem cells are beneficial for any condition.
How are Stem Cells Obtained? How Are They Used?
We harvest a small amount of fat (100-200cc or 3-6oz) from your body, usually your abdomen, thighs, or flanks using liposuction. Because the amount of fat needed is small, this can be considered “mini liposuction”. This procedure, performed using local tumescent anesthesia, is a very easy and painless one to undergo. While the procedure is quite comfortable under local alone, for those who request it we offer mild conscious sedation to make the procedure entirely painless.
Immediately after harvesting, this fat is minimally manipulated (washed and centrifuged) in a special manner using strict sterile technique to isolate the stem cells. Along with stem cells are a variety of other cells that help activate the stem cells and aid in the regenerative process. These cells collectively are known as adipose derived regenerative cells (ADRCs) or stromal vascular fraction (SVF). The ADRCs containing the stem cells are then either injected into a specific joint or tendon and/or administered back to you intravenously.
To reiterate, the ADRCs containing the stem cells are derived from your own fat and therefore are autologous. The harvested fat is minimally manipulated to isolate the ADRCs with the stem cells, and then given immediately back into you either by direct injection of a joint, tendon, or other soft tissue, and/or given to you intravenously.
How Long Does This Procedure Take?
The entire procedure, harvesting the fat, isolating and concentrating the ADRC containing the stem cells, and finally injecting this back into the patient takes about 2-3 hours. Everything is done in one session and in one place, our accredited in-office surgical suite. With preoperative preparation and post procedure recovery, the patient can expect to be in our facility for a total of 4-5 hours.
Where is the Procedure Performed? Where are the Stem Cells Prepared?
The harvesting of the fat by “mini liposuction”, the preparation of ADRCs that contain the stem cells, and the injection of them back into the patient, either into a joint, tendon or soft tissue, and/or intravenously, all take place in our AAAHC accredited in-office surgery suite. We have devoted a section inside our surgery suite itself for preparation of the stem cells from autologous fat that includes a laminar flow hood, Moxi flow cytometer and other specialized equipment to insure the utmost in sterility and viability of ADRCs. Our procedure for preparing the stem cells complies with Good Tissue Practice set forth in the Public Health Service Act Sec 361 and 21 CFR 1271.
What is the Immediate Recovery from A Stem Cell Injection Like? How Much Down Time?
There are two areas that have to heal in patients receiving stem cell injections: the site from which the fat was harvested and the injection sites. The harvest site is usually a small area where we perform “mini” liposuction. While this site can be anywhere there is a suitable fat deposit, the most common areas are the abdomen, flanks or thighs. Patients may experience some mild swelling, bruising, and pain in these areas for one to two weeks, but this will not interfere with normal activities. Patients can return to work in a day or two after the procedure and resume light activity almost immediately. The injection sites, if joints or tendons may also be sore or slightly swollen, but more often than not, they are pain free. Again, normal activity within reason can be resumed within a day. Intravenous injection sites heal usually overnight. Overall down time from this procedure is almost nil.
How Long Before the Beneficial Effects of Stem Cells Are Noticeable?
While is not uncommon for many patients to obtain immediate relief from pain in an affected joint or other area, the regenerative effects usually take about three to six months to occur, peak at about one year and last for two or more years. It must be understood that every patient is different and the benefits from stem cell injections vary.
If the Effects of Beneficial Stem Cell Injections Wears Off, Can They Be Repeated?
Yes. Stem cell injections can be repeated if the initial beneficial effects wear off. There is no known limit to the number of stem cells injections that a person can receive. If desired, excess fat harvested by liposuction can be stored by one of the companies that specialize in banking human fat for future use by carefully freezing it. That fat can be restored and stem cells prepared from it, eliminating the need for further liposuction.
What are the Risks of Stem Cell Injections? Can they Cause Cancer?
The risks of stem cells injections into a joint, tendon, specific soft tissue, or intravenous include the general risks of any injection into any of these areas: localized pain, tenderness, bruising, infection, limitation of movement of the affected joint, localized venous phlebitis. Should one of these adverse consequences occur they are usually short term, easily treated, and rarely result in any long-term problems. There have been no long-term adverse effects of stem cells injections reported to date and absolutely no evidence whatsoever that stem cell injections cause cancer.
The only potential major downside from stem cell injections is that the treatment does not have the desired beneficial effect, either short-term or long-term. There can be no guarantees that stem cell injections will achieve the desired effect.
Can Stem Cells Be Used in Those That Have Had Cancer?
Yes. Those patients that have had cancers and are now considered cured or in remission can undergo stem cell treatment. Those with active cancer cannot undergo these injections.
Are Stem Cell Injections FDA Approved?
No. Stem cell injections are not approved by the FDA. This modality of treatment is entirely investigational. We physicians have the right to administer non-FDA approved treatments as long as we do not advertise them as a cure for any disease. Stem cell injections are not considered the standard of care for any condition nor have been proved to cure any disease. The FDA does have guidelines regarding the treatment and manipulation of a patient’s own tissues. By preparing the stem cells with minimal manipulation and treating our patients in the same session, in the same place, and with their own stem cells, we fall within those guidelines.
Are Embryonic or Fetal Stem Cells Used?
No. Only a patient’s own adult stem cells are harvested and injected back into them. No embryonic or fetal stem cells are ever used.
Does Health Insurance Cover the Cost of Stem Cell Injections?
No. At this time, stem cell injections are not covered by health insurance and must be paid for “out of pocket”.
What is the Cost of Stem Cell Injections?
While individual needs vary and can affect the amount of fat that is needed to insure an adequate number of stem cells to be of benefit, the average cost of stem cell injections in our facility is $5000. This is an all inclusive charge covering the initial consultation, pre operative clearance with blood tests if needed, the harvesting of the fat, the isolation of the ADRCs with the stem cells, and the redeployment of the stems cells into a joint or joints and/or intravenously, and all necessary follow-up visits.