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I'll be the EDITED Stem Cell Therapy Guinea Pig!

Mike86MMike86 Posts: 27
edited 06/11/2012 - 7:40 AM in Lower Back Pain
Hello everybody.

As a background, I have an L4/L5 herniated disc and slight DDD at that same level. I have pain in both legs. Here is my current MRI: http://i.imgur.com/lUqk7.png

After failing to follow instructions correctly during the DRX-9000 spinal decompression treatment and playing the nintendo Wii like a mad-man after 75% of the treatment sessions had been completed, I had another pain crisis and I've decided to look ahead and try out some other treatments. I think that the disc collapsed again after failing to heal completely. I swear the pain was 100% gone, but I had to go ahead and be an idiot and Edited it all up. I guess this is all a learning process. I now know what to do next time.

I've decided to go along with the next treatment: edited stem cell therapy for the lumbar spine. Since I haven't read any real testimonials online regarding the results of the treatment (except for this one lady Edited), I've decided to go forth and try the Regenexx stem cell therapy for the lumbar spine and let you all know on how it goes. I've been researching them for quite a while now and I've decided that their process is legitimate enough to give it a try.

I called them up and they told I need to mail the MRI in CD-format alongside the MRI report. I also needed to complete an online questionnaire which basically asked me what I had been diagnosed with and what I've been doing to try and heal it. You then have to call them again and pay $200 with a credit card for a 30-minute phone interview with one of the main doctors. I, personally, have an phone interview appointment scheduled for this wednesday January 13th at 8:30AM with Dr. Edited. When that time comes, I'll post all the details, SO IF YOU HAVE ANY QUESTIONS THAT YOU WOULD LIKE ME TO ASK, SEND ME A MESSAGE OR POST IT HERE PLEASE! Here's a list of questions that I am currently planning on asking:
-Won't the stem cells die off if the disc has disc degenerative disease?
-What kind of therapy should I be doing alongside the treatment?
-What is the success rate with the lumbar disc stem cell treatment?
-How soon should I EXPECT to see results?

So I guess I'll be the guinea pig here! If this doesn't work, I'll be going to the Stenum Hospital in Germany for the M6 Lumbar Artificial Disc Replacement. It looks too awesome to be left out! In any case, I will have another MRI done after the treatment.. you know, for comparison purposes. I will also post graphs with pain levels and other stuff.

In case you don't know what Regenexx is, look it up on google and go to their website. What they do is they take stem cells from your bone marrow in the first session. They then reproduce them and three weeks later they inject them directly into your disc. A week later they do it again. The clinic is near Denver, Colorado.



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Please note that Spine-Health reserves the right to edit any messages posted or submitted or e-mailed to the Company and use them for content on the website or in other company materials. No e-mail solicitation or advertising of other companies, products, services, or web sites is permitted in the Spine-Health.com forums.

Post Edited by Authority Member haglandc
Successful ADR patient with a Spinal Kinetics M6-L on L4/5. Details, photos, surgery pics here: http://healingmyback.blogspot.com


  • I just did an internet search on this company, and I found a lot of negative comments about this procedure and about the Doc that is head of this company. If I was you (unless you have money to throw away), I would not give them $200.00 until you talk to patients, (if it works, they would allow you to do that), and until I read everything that is out there about this company and why is it that the FDA has not given them the green light to do this experimental procedure.

    Another thing that comes to mind.... If this treatment is experimental and if they are doing trials, they should be perform for free, they should not be charging patients for their services. I'm just saying......


    Standards agreement and posting rules
    Please note that Spine-Health reserves the right to edit any messages posted or submitted or e-mailed to the Company and use them for content on the website or in other company materials. No e-mail solicitation or advertising of other companies, products, services, or web sites is permitted in the Spine-Health.com forums.

    Edited by moderator paulgla

  • I find that these negative comments online are merely speculation, and not from actual patients. This procedure is being done in Europe, and I don't wanna go all the way over there just for an injection! And I don't really have money to throw away, but I do have money to invest in my health. Thanks for caring though..

    If anyone else has any experience with the company, let me know ASAP.

    I'll make my decision this wednesday!

    Cheers everyone.
    Successful ADR patient with a Spinal Kinetics M6-L on L4/5. Details, photos, surgery pics here: http://healingmyback.blogspot.com
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  • When you do your online search, look for the letter that the FDA wrote to the Doctor that runs this company, it was very easy to find, I found it with a simple google search.
    If after reading the letter you still think that this is a legitimate place to receive treatment, go ahead.

    I know that this type of treatment is been done in Europe, but the methodology is completely different. This Doctor does not even have approval to be doing this type of treatment in the USA, so some food for thought.......
  • Tipper, you may want to do more homework on the FDA issue. The FDA has as much authority over the practice of medicine as the FAA or IRS. This is a copy/paste from their FAQ's:

    When a physician performs a stem cell therapy in the ordinary course of his or her medical practice, must that therapy be FDA-approved?

    The Food and Drug Administration’s (FDA) power to regulate in the public interest must always be grounded in a valid grant of authority from Congress. Between 1906 and today, Congress has granted authority to the FDA on dozens of occasions to regulate food, drugs, cosmetic products, biological products, radiation-emitting products, and veterinary products. Congress has never, however, granted the FDA the authority to regulate the practice of medicine. Indeed, it is well settled that the individuals retain the power to regulate professions, including the practice of medicine.

    EDITED consists of two physicians who operate a small medical facility in Broomfield Colorado and treat patients there. Both of edited’s physicians are licensed to practice medicine in the State of Colorado and all of edited’s patients are treated exclusively inBroomfield. edited’s surgical procedure involves the use of autologous stem cell therapies (ACTs) which involve the in vivo use of a patient’s own stem cells, following in certain circumstances, ex vivo processing for the treatment of the patient’s injuries. The procedures performed by RSI, including surgery and bone marrow re-implants, are not performed as part of any research intended for FDA approval of a product that is under the jurisdiction of the FDA. Rather, edited’s physicians perform these procedures exclusively as part of their medical practice and in a one-on-one capacity with their patients. Consequently, these procedures are considered the “practice of medicine,” and left up to individual surgeons’ judgment and experience and oversight by the Colorado Board of Medicine. Consequently, because the FDA does not have the jurisdiction to regulate the practice of medicine, it likewise lacks the jurisdiction to regulate these procedures.

    A simpler Explanation:

    The restaurants at which we dine on a daily basis are not regulated by the FDA. Why? First and foremost, the United States Congress has not given such jurisdiction to the FDA. Instead, Congress has left the regulation of restaurants to the departments of health in the states where the restaurants are located.

    Congress has made this choice for a variety of reasons. First of all, the departments of health of the independent states are perfectly competent to regulate the services we receive on a one-on-one basis. This applies equally at your local barbershop, restaurant, hospital, and doctor’s office. At a restaurant, the public health risk of tainted food is a one on one risk. At worst, a restaurant with a substandard kitchen might make a few people ill. For this reason, both the restaurant and the doctor are regulated at the state level.

    Now let’s say our restaurant has a popular menu item that it wants to place in jars and ship across state lines to customers placing orders. All of a sudden the public health risk escalates dramatically. The food in jars shipped nationwide has the potential to make huge numbers of people ill with just one tainted batch. In such circumstances, the restaurant is no longer just a restaurant. Instead, the restaurant has become a food production facility, the public health risk has become a federal one, and the FDA thus has the jurisdiction to regulate it. The same holds true if a doctor’s office decides to place stem cells in a vial and ship those to other doctors in other states. Indeed, just like the restaurant mass producing food and shipping it around the country, the public health risk is much larger and involves potentially all 50 states.

    While there is no doubt that we would all want the FDA to have regulatory authority over stem cells shipped in a vial, what would happen if we had FDA regulate restaurants? Since every kitchen would need cGMP kitchen (meaning up to the standards of mass food production) the cost of eating out would become prohibitively expensive. A ten thousand dollar prime rib anyone? Similarly, what would happen if FDA regulated your doctor? The cost of delivering medical care would skyrocket in cost but plummet in speed and effectiveness. Indeed, if the FDA did in fact regulate your physician, every time you visited him for a treatment, that treatment would have to undergo a 7-10 year FDA approval before you could receive it. Just as there is no public health rationale for having FDA regulate restaurants, there is also no public health reason for FDA to regulate your doctor’s medical practice.

    Standards agreement and posting rules
    Please note that Spine-Health reserves the right to edit any messages posted or submitted or e-mailed to the Company and use them for content on the website or in other company materials. No e-mail solicitation or advertising of other companies, products, services, or web sites is permitted in the Spine-Health.com forums.

    Edited by moderator paulgla

  • Greetings everyone.

    And thank you for your comments!

    Regarding the discussion above, I agree with Shawton3. I think people should have more freedom to try out new stuff. Going to europe is way too expensive.. Plus, we have excellent doctors in the US that need to catch up to world health standards and progress!

    Btw, I had a terrific phone conversation with Dr. Edited this morning.

    First he gave me his diagnosis, which was professionally done. He told me I lost some height on my disc and that the left-leaning bulge (note that it hasn't yet leaked out) he diagnosed was consistent with my intense left-side pain. He then went into explaining how candidacy for this type of treatment works:

    **Good Candidate**
    MRI imaging that shows single level disc degeneration
    with disc height maintained at greater than 50%. Disc
    protrusions and posterior longitudinal ligament are
    intact. No previous lumbar spine surgery. Patient age is
    less than 50 years with radicular symptoms that
    correspond anatomically with disc pathology.
    Transforaminal injections eliminated radicular pain.
    These patients are in the same general category of
    patients who have shown consistent pain/functional
    changes with the Regenexx procedure.

    **Fair Candidate**
    MRI imaging shows one or more lumbar discs that are
    degenerative in nature with disc height reduced by 50%
    or more. Disc protrusions and posterior longitudinal
    ligament are intact. No previous lumbar spine
    surgeries. Radicular symptoms may not directly
    correlate anatomically with disc pathology.
    Transforaminal injections afforded only partial relief of
    radicular pain. These patients may have a higher risk of
    failure with Regenexx procedure to change their

    **Poor Candidate**
    MRI imaging shows multiple levels of disc degeneration,
    disc height of affected levels reduced by move than
    50% and protrusions are not contained. Reactive
    endplate changes noted along with advanced reduction
    in disc signal. History of prior lumbar surgery. Patient
    age over 50 years. It is unlikely that the Regenexx
    procedure will be helpful for this patient.

    He sent me a report with this information after the conversation was done. I fell into the FAIR candidate category. He recommended I go ahead with the treatment given his past patient's success with this type of condition.

    He says the first phase of the treatment involves a bone marrow extraction. The second visit involves them injecting me with a PTP (Platelet Rich Plasma). He says he wants to increase circulation and hydration in the disc using this (I assume this is so the stem cells work in an adequate environment). The third visit involves the actual injecting of stem cells into the damaged disc. This is repeated two more times for a total of 5 visits.

    Also, I asked him a couple of questions:
    -Won't the stem cells die off if the disc has disc degenerative disease?
    -What kind of therapy should I be doing alongside the treatment?

    I'll post more details tonight as I have a flight to catch right now. If you guys want a copy of the report send me a message with your e-mail address and I'll e-mail it back.

    Thanks for listening people! I sure hope this works.

    Post Edited by Authority Member haglandc to remove name of medical professional
    Successful ADR patient with a Spinal Kinetics M6-L on L4/5. Details, photos, surgery pics here: http://healingmyback.blogspot.com
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  • I too prefer freedom of choice.
    Mike, best wishes for you on this tretment! I hope it goes great and you benefit greatly from it. Will be watching your story.
    On the sunny and mild Central Coast of California

    L4-L5 endoscopic transforaminal microdiscectomy June, 2007
    L5-S1 endoscopic transforaminal microdiscectomy May, 2008
  • Well if people get preyed upon the market will dictate the success of the treatment. They can't go on forever if they're scamming everyone. That's why I prefer a free choice.. sure, somebody will get burned, but it sure in heck beats waiting 10 years for a treatment to get approved given that a treatment is legitimate.

    Anyways, I'm posting some more details from the phone conversation here:

    Negatives for me:
    One of the negatives is that there is a herniation. Also, a high intensity zone, a tear in the outside fibers of the discs. I would put you in the 'Fair' because of the extent of the herniation or bulge. But I think you would do well.

    Other comments:
    Part of our therapy isn't only putting cells in your disc, but also some growth factors from platelets to attempt to increase the blood flow.

    Do they have a chance of restoring the disc if it is diseased?
    Yes. Darkness on the MRI indicates that the proteins in the disc are not holding any water, so it is degenerative. The disc should turn white in the MRI, which means it is restoring its moisture. We've also had patients that have had reduction in their disc protrusion as well.

    Any physical therapy alongside the treatment?
    Well, NO WEIGH-LIFTING. Back strengthening and core stabilization is always useful. An inversion machine is great. You don't have to stand on your head with an inversion table. Just get used to lying parallel to the floor and teeter a little, 5 degrees. Don't engage your cord too much.. up to 10 or 15 degrees.. maybe take a nap on it if you're talented.

    How have people been doing in general?
    "people have done well. We continue to evolve our techniques, and I would say you have a good chance of reducing your back and leg pain."
    Successful ADR patient with a Spinal Kinetics M6-L on L4/5. Details, photos, surgery pics here: http://healingmyback.blogspot.com
  • Hello everybody.

    In regards to paulgla, I understand your skepticism. I'm skeptical as well. However, my impressions of a 'scam' were pretty much put to rest today with the welcome packet they sent me by e-mail. Boy it's exhaustive and thorough! I too have read many things on the company online, but they're not reviews, they are just skeptics writing blogs. They were never patients so they will never know. I know I am taking a risk here, but given my condition anything is worth a try. I have the financial fitness to do it and the mental maturity to realize whether this is a scam or not, and form what I've read and heard, it's a legitimate procedure that doesn't involve a simple injection. I'll show you why.

    This comes from the pre-op packet they sent me:

    Bone Marrow Draw
    During the marrow draw, the medical provider places a needle in the back of the hip area to obtain what is called whole marrow (looks like thick blood). The procedure can cause soreness in the low back for several days to a week. The amount of soreness will vary, but will usually starts once the numbing medicine wears off (a few hours). Do not take a bath, sit in the hot tub, or swim for 3 days. A shower 12 hours after the procedure is fine. If you have a history of low back pain, it is common to have more soreness from the marrow draw. If you have redness, pus, fever, chills, sweats, or any other symptoms that look like an infection, please contact the doctor.

    Fluid and Food Status
    Air travel and change in elevation can predispose patients to dehydration. Please drink plenty of clear liquids or water 48 hours prior to and following bone marrow aspirate and blood draw (approximately 64 ounces a day). Avoid or minimize caffeinated products such as coffee or soda 24 hours prior to the procedure. Eat a full breakfast on the morning of the procedure. Avoid strenuous activity or heavy lifting for at least 5 hours after you donate blood.

    On the day of your initial appointment, you will be asked to complete some paperwork. You will meet with the doctor. Please be sure to bring any pertinent or requested information, including imaging and paperwork, if not sent previously.

    Steroids, NSAIDs (ibuprofen, aspirin, naproxen, COX-2 drugs such as Celebrex), certain asthma and allergy medications, statin medications for high cholesterol, as well as other medications and supplements described in the medication information sheet should be discontinued 2-4 weeks prior to the bone marrow draw through 6-12 weeks after the re-injection of cells. It is your responsibility to discuss this with the doctor who has ordered these medications for you. Please inform the doctor of all medications you are currently taking. Please review medication restriction list. Disregarding the recommended medication restrictions may significantly decrease the success of your procedure.
    Approximately 1 week prior to the bone marrow and blood draw appointment, you will come in for a blood draw of a small amount of blood (6 small tubes). This will be used for an epidural in the disc area at the time of the blood marrow draw.

    For the blood, epidural, and marrow draws please be sure to have eaten a light meal 1-2 hours prior to the procedure. It is very important that you drink plenty of fluids and are well hydrated prior to the procedure. If you come from a lower altitude, it is especially important to drink plenty of fluids (approximately 64 ounces a day). To have the best results from your bone marrow draw we recommend mild, low-impact exercise 2-4 weeks prior to the procedure. Eat a healthy, well balanced diet. Dieting at this time is not recommended.

    The blood draw is about the same as donating blood. During this appointment, you will have blood drawn from your arm – approximately 2 cups. This is approximately the amount you would give if you were donating blood.

    You will be taken back to the procedure room where you will be prepared for the epidural and bone marrow aspiration. The epidural consists of an injection to the back using cells from your blood. The bone marrow procedure will require you to have a bone marrow sample taken from the back of each of your hips (iliac crest). You will lie on your stomach on the procedure table where an area at the back of your hip will be numbed. A special needle will be used to draw marrow blood out of the back of your hip (back of the iliac crest). X-ray will be used to assure the optimum location. This will be done on both sides of your hips. If you have pre-arranged to take Valium prior to the procedure, you must have a driver with you. This will be discussed with you when you schedule your appointment. Please refer to the post-operative instructions for activities after this procedure. A pre-injection to the disc area will be performed during this appointment.

    You will come back for the next set of appointments which are scheduled several weeks later. You will have the re-injection of cells and epidural using cells from your blood. Follow up epidurals using cells from your blood will be at 2 weeks and 4 weeks after the re-injection of cells. Please understand that it is not possible to make a an absolute pre-determination of the treatment plan that will be most appropriate for your condition and that only after being evaluated can the doctor determine the best plan for you.

    You will be asked to remain still in the medical office for approximately 1 hour after the procedure. After the procedure you may eat and drink as tolerated. Please refer to the post operative instructions for activity after your procedures.

    Myofascial Treatment: Many of our patients have significant problems with their ability to move through a full range of motion because of trigger points in the surrounding muscles. These are portions of the muscles that go off line and prevent movement. These problems tend to significantly increase forces in the areas where we want to regenerate tissue matrix. As a result, we recommend that the patient use this time to identify a good myofascial trigger point therapist and to initiate treatment before the cells are placed back. If you are in Colorado, we can take care of these needs. If you are from out of town, here are some resources on the web:

    Finding a therapist and working on eliminating these trigger points while increasing range of motion will help your chances of success.

    Nutrition: We recommend that you take Collagen Type II Supplement. We offer Collagen II Joint Formula through our office. You can get this medication in the office or we can send it to you. Unfortunately, this particular brand is only available to medical professionals. Take 4 pills orally with breakfast and 4 at bedtime (without food) for the first 2 weeks after your marrow draw, and then 2 pills a day and then 2 at bedtime (without food) for the next 6 weeks. If you wish to take your own supplements, they must at a minimum contain:
    • Collagen Type II (Collagen II Joint Supplement 4 pills contain 1500 mg) • Hyaluronic Acid (Collagen II Joint Supplement 4 pills contain 50 mg) • Manganese (Collagen II Joint Supplement 4 pills contain 10 mg) • Vitamin C (Collagen II Joint Supplement 4 pills contain 120 mg)

    You should supplement this collagen formula with Glucosamine and Chondroitin. The dose is 1500 mg of glucosamine and 1200 mg of chondroitin daily for 2 months. You can purchase these at a drug store. We also recommend Cosamin DS as a great source of these joint supplements Edited. Realize that if you are allergic to sea food, this may be a problem with Glucosamine products. In addition, they can change your bleeding times if you on being monitored on Coumadin.

    Since you have a tissue matrix problem and we want to support healthy maintenance of this tissue matrix, you should be on these supplements long-term.
    Inversion Table: Please discuss with the doctor recommendations regarding the use of an inversion table – both prior to and after the procedure. Here is one resource with information: Edited

    Helping Cells Grow – Blood Flow: You will be asked to use an infra-red unit while you’re sitting at work or home after the re-injection procedure. You should be instructed on how to use this unit on check out. Use up to 30 minutes twice a day for 6 weeks. Please be cautious not to exceed 30 minute intervals! Infra-red units are available for purchase Edited. They are available in several sizes; please review what would be appropriate for you.

    Post-Op Instructions for Disc Procedure
    Immediately After Your Cell Transplant Procedure
    Activity: The goal is to allow the stem cells to attach and then to protect them while they differentiate into disc tissue matrix. For this reason, you’ll be asked to keep remain as still as possible for 30-60 minutes after the procedure. Do not take a bath for three days, but a shower 12 hours after the procedure is fine.

    1st – 3rd Day: For the first day, you should limit activity. If you have post-op soreness this may be easy to do, as your body does this to reduce pressure on the area to allow healing. Avoid all contact sports as well as jogging, running, or sports that involve impact on the spine.
    4th Day - 2nd Week: You can start to walk normally, no more than 30-60 minutes a day. Avoid all contact sports as well as jogging, running, or sports that involve impact on that spine. Bike riding is fine as are stationary bikes, elliptical machines, and swimming.
    3rd-6th Week: Avoid all contact sports as well as jogging, running, or sports that involve impact on the spine. You can walk as much as you like. Bike riding is fine, as are stationary bikes, elliptical machine, and swimming.
    After the 6th Week: Start integrating back all desired activities, adding back 20% per week. For example, if you were used to running 10 miles a week, you would start at 2 miles a week, then the next week add back another 2 miles, and so on...

    If recommended, continue traction 3-5 times a week for 4-6 weeks after the stem cell re-injection.

    Medications: You can’t take anti-inflammatory drugs such as Motrin, Alleve, Ibuprofen, or similar NSAID’s. These need to be avoided for 6-12 weeks after the procedure. In addition, any other drugs you have been asked to avoid, should also be stopped for the same time period. Please review the Medication Restriction sheet sent previously. Most statin cholesterol lowering drugs will move stem cells toward producing bone, which is not what we want here, so these need to be avoided for 6-12 weeks. Steroid medications (such as steroid based asthma inhalers, oral steroids, or steroid injections into a joint) will dramatically impair stem cell function, so these are to be avoided as well.

    Pain: If you have pain from the procedure, this should resolve within the first 1-3 weeks. If it does not, contact your clinic doctor. During those 3 weeks, take your post-op pain medications. If you need to get more post-op pain medication, please contact your clinic doctor. Tylenol is acceptable to take as well.

    Alcohol and Marijuana:
    Alcohol can have profound negative impacts on stem cell function, so this should be avoided for the same 12 weeks. A glass of red wine or white wine with dinner is not a problem, but more than that could pose a risk to the cells. Cannboids such as Marijuana can also promote bone formation over tissue matrix (not what we want in this case), so should be avoided.

    Complications: Call your clinic doctor if you have excessive swelling, fevers, chills, sweats, local hardness, redness, or pus at the injection site. Please contact us if you have any concerns about infection or any other concerns.

    Taking Medications to Help Disc Nutrition
    We'd all accept at face value that if you wanted seeds to grow into healthy plants, the quality of the soil would make a difference. The same holds true for placing stem cells into your low back discs. Research has shown that one medication in particular may help improve the nutritional environment in the low back discs. This medication is ********. In higher doses than we prescribe for discs, it's used for high blood pressure or in patients with stroke or brain injury.

    NOTE: They also gave me a HUGE list of medications I shouldn't be taking. I erased a few details given that they may be proprietary to their procedure.

    They also sent me some paperwork that i'll be filling out and sending in, alongside payment instructions and an invoice, which I'm supposed to pay a small deposit of when I schedule the appointment. The rest is due in parts during each of the sessions.

    I also assisted to one of their webinars.. Dr. C answered everyone's questions thoroughly. I can't imagine all the time these guys are putting into this clinic, especially with the amount of misinformation online.

    It seems the procedure is being perfected. Also, it seems that they have had some problems with some patients before, especially with adverse reactions to certain medicines. In any case, I'll be giving it a try and you guys can follow the whole thing..

    Wish me good luck!


    Standards agreement and posting rules
    Please note that Spine-Health reserves the right to edit any messages posted or submitted or e-mailed to the Company and use them for content on the website or in other company materials. No e-mail solicitation or advertising of other companies, products, services, or web sites is permitted in the Spine-Health.com forums.

    Post Edited by Authority Member haglandc
    Successful ADR patient with a Spinal Kinetics M6-L on L4/5. Details, photos, surgery pics here: http://healingmyback.blogspot.com
  • Thanks Mike86!
    I am very interested in this type of treatment.
    Please keep us updated! :)
  • Personally I would never take any stem cell treatment; unless I was guaranteed that the stem cells did not come from aborted fetus's, and came from umbilical cord blood instead. This issue has as much to do with morality and ethics of the patient and doctor as it does of whether or not it is a legitimate treatment.
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