Frequently Asked Questions
How is the Stem Cell Manila Procedure different from other stem cell procedures currently being offered for orthopedic conditions?
When we first began offering orthopedic stem cell therapy in 2005 as part of an IRB approved medical study, we were one of the few clinics in the world treating orthopedic problems with stem cells. When we began treating everyday patients in 2007, this was still the case. Now other clinics are beginning to offer basic cell therapies, most in plastic surgery and cosmetics, with a few clinics just starting to try orthopedic therapies. While we welcome the growth in cell based medicine, we also know that we're world leaders in this area. As leaders, we set a higher standard for ourselves in all of the cell-based procedures we offer our patients. We have 2 pages dedicated to explaining the substantial differences between Stem Cell Manila and other stem cell solutions:
What types of conditions can be treated?
Click on the body part that you are interested in below. While this is not a complete list, it will provide you with the most common treatments by body part. If you have a question about whether your condition can be treated, please call us at 888-525-3005, or contact your nearest Stem Cell Manila Network Provider Select a Problem Area If you have pain, we're here to help. Stem Cell Manila Procedures are patented stem cell and blood platelet procedures that are used to treat a wide range of joint and spine conditions.
Is a Stem Cell Procedure the same as PRP (Platelet Rich Plasma)?
No. PRP is concentrating platelets in the blood, not stem cell therapy. This is a more detailed discussion on the differences between PRP and stem cell therapy. In addition, while PRP is one component of the therapy, we use a very different �Super Platelet Mix' which we believe helps to produce many more stem cells. We do offer the Stem Cell Manila Super Concentrated Platelet Rich Plasma Procedure, which is a platelet procedure that is quite different from the bloody PRP commonly available using bedside centrifuges. To see a patient infographic on these differences, see this link for general info on the Stem Cell Manila platelet procedure and this one for a comparison between our process and typical bedside PRP machines.
Are the Stem Cell Manila procedures covered by insurance?
No, these procedures are too new to be covered yet. Don't let someone fool you, PRP and stem cell injections have no insurance coverage at this time. Some health insurance plans may cover the initial evaluation. If your plan does, and we are part of your insurance carrier network, we will bill the carrier. If not, there will be a consultation fee for the initial face to face consult. We recommend that you contact your insurance carrier for more information about your specific coverage details.
Price / Cost: How much do Stem Cell Manila procedures cost?
Because the procedure protocol will vary from person to person and because each person will have a unique condition to be treated, the pricing of procedures can vary considerably from patient to patient. An evaluation will give you a better idea of condition, treatment and costs specific to your condition. The chart below provides a general idea of the procedures and where they fall in terms of cost and severity of conditions treated. Platelet procedures cost considerably less than stem cell procedures.
Do mesenchymal cells stay localized to the injection site? Is there any risk of them traveling throughout the body?
MSC's do stay localized to the injection site across multiple studies. This is likely linked to the fact that they generally do not circulate in the blood stream like other adult stem cell types and are primarily found resident in the tissues they serve.
How will my stem cells know when to stop growing?
Unlike embryonic stem cells, adult stem cells do not generally keep growing, even in culture. For example, most patients whose stem cells we grow to bigger numbers in the lab will lose their ability for continued cell growth after just a few weeks. In addition, the same body signals that would tell these cells to stop growing in healing a normal fracture or ligament tear are still present in your body.
What triggers the cessation of cell growth during regeneration? Has regeneration ever surpassed expected optimal growth?
Mesenchymal stem cells will stop proliferating when they physically contact each other (otherwise known in cell culture lingo as �confluence�). Culturing these cells, it becomes obvious that once they reach that point, they refuse to continue to grow (proliferate). This is because they are repair cells and when an area in need of repair is fully covered, they get the signal to stop growing. In patients where we have ongoing MRI surveillance of the re-implant sites, there has been no evidence of overgrowth where the regeneration has surpassed �expected optimal growth�.
X-Ray vs. MRI
Because an x-ray will only show the condition of the bone, not the soft tissue, the doctor needs an MRI to accurately evaluate the condition of the whole area. If a patient is unable to have an MRI, a CT arthrogram is acceptable. We will review an x-ray for non-union fractures only. The doctor will need the most recent MRI available. The MRI should be without contrast and less than two years old. If you've had surgery or a scope done since having the MRI, we would need an MRI that was taken after the operation / procedure.
Are the Stem Cell Manila procedures performed in the U.S. approved by the FDA?
Yes � The Stem Cell Manila procedures performed in the United States are compliant with CFR 21 Part 1271 and fall under the same surgery exemption discussed in 1271.15 (b). All of the Stem Cell Manila Stem Cell and Blood Platelet Procedures performed in the U.S. today are same-day procedures that are compliant with CFR 21 Part 1271, falling under the same surgery exemption discussed in 1271.15 (b). Unfortunately, there still remains some confusion about Stem Cell Manila, largely as a result of a few individuals who have written about our case against the FDA throughout the last few years, but who did not fully understand that the case relates only to the Stem Cell Manila-C Procedure. This single procedure, which is different from the procedures now performed in the USA, is only available in the Cayman Islands through an independent vendor who has licensed the procedure and has not been performed in the U.S. since August of 2010. No � The FDA does not �approve� or �not approve� medical procedures (like gall bladder surgery for example). This is considered a medical procedure. We are in compliance with all procedure codes; the FDA does not have any issues with the procedures we offer in the U.S. All of the Stem Cell Manila Stem Cell and Blood Platelet Procedures performed in the U.S. today are same-day procedures that are compliant with CFR 21 Part 1271, falling under the same surgery exemption discussed in 1271.15 (b). Unfortunately, there still remains some confusion about Stem Cell Manila, largely as a result of a few individuals who have written about our case against the FDA throughout the last few years, but who did not fully understand that the case relates only to the Stem Cell Manila-C Procedure. This single procedure, which is different from the procedures now performed in the USA, is only available in the Cayman Islands through an independent vendor who has licensed the procedure and has not been performed in the U.S. since August of 2010. Stem Cell Manila FDA Clarification What's the Difference Between these Procedures? All of the procedures performed in Colorado and throughout our U.S. Stem Cell Manila Procedure Network are same-day procedures. This means that the patient's cells are harvested in the morning, isolated and processed, then re-injected into the patient's injured area � all within a period of a few hours. The Stem Cell Manila-C Procedure, which is only performed at Stem Cell Manila Cayman, involves harvesting the cells on the patient's first visit, growing them to larger numbers over approximately two weeks, testing the cells, then re-injecting the cells during the patient's second visit. [Disclaimer: The Stem Cell Manila same-day procedures are performed in the United States. The Stem Cell Manila-C cultured stem cell procedure is only offered outside the U.S. through independently owned and operated medical services providers operating exclusively in countries that allow autologous cultured cells to be used through their local regulatory structure. These service providers are not part of nor affiliated with the Centeno-Schultz Clinic nor any U.S. Stem Cell Manila Network provider. The Stem Cell Manila-C procedure licensed by these entities is not approved by the U.S. FDA for use in the United States.]
What complications have been experienced with the procedures?
Using the HHS OHRP guidelines for complications reporting, our complications to date have been in the mild to moderate category and rare. This means that either the complication (like transient swelling) required no medical treatment (Mild), or if it did require medical treatment, the treatment was simple (Moderate-like a patient who failed the procedure who ultimately decided to get the knee replacement that he or she was planning before the procedure). We have published the world's largest (to date) safety and complications tracking study of adult stem cell use in patients. This study did not show any serious stem cell related complications and it did not show that any patient developed a stem cell related cancer.
Can an adult stem cell re-implant cause cancer?
The basic science on adult stem cells shows that if the cells are kept in culture for short periods, there is no risk of the cells becoming cancerous. We have published the world's largest (to date) safety and complications tracking study of adult stem cell use in patients. This study did not show any serious stem cell related complications and it did not show that any patient developed a stem cell related cancer. Finally, we maintain an extensive complications tracking database with patient contacts at specified times. We have seen no evidence of significant complications at these re-implant sites. We also work with an outside lab for quality to clear each patient's cells before they are used in treatment as an additional safety check.
What has been the longest time period of observation that leads you to conclude there is no tumor risk?
Approximately 10 years.
Is a fat liposuction safer than a bone marrow aspirate?
No, an analysis of the published research shows that liposuction is more risky than a bone marrow aspirate.
Are there any medications or supplements I can take that will increase the activity or healing abilities of my stem cells?
We produced the Stem Cell Manila Advanced Stem Cell Support Formula to support healthy stem cell function and cartilage production.
Why can't I be on certain medications during the procedure?
Certain types of medications will negatively impact the stem cells. In addition, we generally see that many prescription medications will reduce stem cell number.
What if I take Coumadin, Plavix, or other blood thinners?
We generally recommend that you stop these before the procedure. For example, if you take Coumadin, you need to have the OK of your family doctor or cardiologist to come off this drug and an INR (blood clotting test) that is in the normal range before pursuing this procedure. If you take other blood thinners such as Plavix, you should be off this drug for 72 hours prior to the procedure. Your family doctor or cardiologist may also need to be consulted to ensure that it's safe to come off of this medication. If you take a daily baby aspirin, then you need to come off this one week before the procedure.
What if I have a blood clotting disorder?
If your clotting times are normalized by taking clotting factors, then there should be no problem performing the procedure.
Where Can I Get a Stem Cell Manila Procedure?
We've been working hard for several years growing our provider network and are continuously training doctors to perform the Regnexx procedures. We have very high standards for our network doctors and are extremely selective in allowing doctors to join the network. Please visit our Locations page for a complete list of Stem Cell Manila Providers to find the one nearest you.
Phone review of your condition
While we prefer to see someone in person to review their condition and evaluate whether they would be a good candidate for Stem Cell Manila, many of our network doctors offer an initial phone review of your condition if it's inconvenient for you to drive to your nearest provider for an office visit. The doctor can look at your films, history, and speak to you on the phone about whether he or she believes this may help your problem. It's important to note that this is not the formation of a traditional doctor�patient relationship until you actually visit the doctor. Rather, this is just an opportunity for the doctor to determine if you're a reasonable candidate for the procedure and for you to ask addition questions. The doctor will require an MRI on CD / DVD or an uploaded version of your MRI in order to review your imaging. Check with your local Stem Cell Manila provider on how to deliver your MRI to them. There is a charge for phone reviews with a Stem Cell Manila doctor, so check with your local Stem Cell Manila Provider to learn more. If you are determined to be a qualified candidate and choose to have a procedure, this fee will be applied to the cost of a stem cell treatment. The fee is not applied to the cost of treatment for our platelet procedures, which are lower cost.
What should I know about the bone marrow aspirate?
Patients often confuse a bone marrow aspirate with a more involved and more painful bone marrow biopsy. We only perform the less involved and much more comfortable bone marrow aspirate. This is a short (20 to 40 minute) in office procedure where the skin and tissues are numbed and a needle is used to withdraw marrow blood, which contains the stem cells. One site on each will be numbed and three samples are taken from each site. Because the area is extensively numbed, 88% of our patients report that the procedure is very comfortable and would do it again. To better access how our patients feel about this procedure, we ran questionnaires on 44 consecutive patients undergoing marrow draws (primarily in Jan-Feb 2009). 86% said they had no to mild discomfort. 88% said that the procedure was either less uncomfortable or about what they thought it would be. 88% also said they would do it again without hesitation. A properly performed marrow aspirate procedure should not be uncomfortable to the vast majority of patients.
How painful is the procedure for implanting stem cells?
About as painful as a typical shot in a doctor's office.
How do you know where to place the cells?
We use real time x-ray known as fluoroscopy or musculoskeletal ultrasound. Your MRI images are used to help plan that injection.
How long do I have to stay for the procedure?
There is virtually no down time with this outpatient procedure. The entire process will take anywhere from 2-8 days depending on the doctor's recommendation. You can walk right out of the clinic the same day any procedure is completed. For all blood-derived procedures (SCP, PL), you will only need to come in for one day for treatment.
Do I need to have someone drive me?
All of our patients walk out of the clinic. However, having someone drive you for a medical procedure is never a bad idea. On occasion a local nerve block may be used, which could impair your ability to drive safely, so you should consult with your doctor or clinic about your specific treatment and protocol to ensure that it will be safe for you to drive if you wish to do so.
What basic science or published clinical data exists that show that these concentrated stem cells from bone marrow can help heal orthopedic injuries?
Stem Cell Manila stem cell procedures have been studied extensively for more than a decade and our patients are part of the world's largest human mesenchymal stem cell re-implantation database for orthopedic purposes. We regularly publish outcome data from this patient registry and make it available to the public.
Can a Second Procedure Be Helpful?
Our analysis of patients who have had a second procedure shows that very often a second procedure can help continue and improve the success a patient has from our regenerative treatments.
When can I expect to feel better?
The results should become apparent over 1-3 months, but sometimes can take as long as 6-9 months.
Will I need a second procedure?
Should I take specific supplements after my procedure?
Yes, we have developed our own supplement based on lab tests with human mesenchymal stem cells and their response to various nutritional supplements.
When can I return to normal activity?
This depends on the type of procedure. However, all of our procedures are designed to promote as much early activity as possible. Here is a general guide: Bone healing procedure (for fracture non-union or avascular necrosis): You must be off the area on crutches until the pain from the procedure subsides. You can then move toward slowing increasing activities over the next few weeks. Total time off the area for most patients is 1-3 weeks with normal activities at about 6 weeks. The only exception is when there is an existing rod or plate stabilizing the fracture site, in these cases you will be allowed more activity more quickly. Joint procedure. If there is more minimal cartilage loss, low impact activities would be encouraged immediately after the procedure. Full high impact activities would be expected at 4-6 weeks. Partial tendon/ligament/muscle tear: Low impact activities would be encouraged immediately after the procedure. Full high impact activities would be expected at 4-6 weeks.
Is physical therapy needed after the procedure?
In general, we always try to look at more than one injured part. As a result, it's very likely we will recommend other types of conservative care to restore normal biomechanics. This might include physical therapy, different types of myofascial release, or specific home exercises.