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Biologics Feature

Normal cells / Source: Wikimedia Commons and National Cancer Instititute
Normal cells / Source: Wikimedia Commons and National Cancer Instititute

Major Study Update: Stem Cells Ease Back Pain

Biloine W. Young • Thu, May 2nd, 2013

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Mesoblast, the highest value stem company in the world, released the latest in string of studies examining the ability of a certain type of stem cell to treat back pain.

In its earliest test of its stem cells (known as mesenchymal precursor cells – MPCs) the company injected its MPCs into three adjacent lumbar discs in 24 adult male sheep. The MPCs were injected intradiscally. The particular sheep model that was used (Journal of Neurosurgery: Spine May 2012; Vol. 16; No. 5; Pages 479-488) was one where some discs were injected with chrondroitinase in order to mimic disc degeneration and other discs were left alone to represent normal discs as a control arm in the study.

In the sheep test, the degenerated discs had 45-50% less height before treatment with Mesoblast’s MPCs. After MPC treatment the discs rehydrated and increased in height at rates that were statistically significant as compared to the controls. It was, in fact, a significant and highly important animal study and set up Mesoblast’s human study.

This past week, Mesoblast released its second round of preliminary results from this Phase 2 human study of MPCs as an intradiscal injection treatment for back pain.

In the study, researchers injected allogeneic mesenchymal precursor cells (MPCs) into damaged intervertebral discs in what is, essentially, a one hour outpatient procedure.

This is the six-month follow-up data. All 100 patients have been enrolled.

Researchers Kasra Amirdelfan, M.D. (IPM Medical Group, Walnut Creek, California), Hyun Bae, M.D. (The Spine Institute, Santa Monica, California, Domagoj Coric, M.D. (Carolina Neurosurgery & Spine, Charlotte, North Carolina), Tory McJunkin, M.D. (Arizona Pain Specialists, Phoenix, Arizona), Michael DePalma, M.D. (Virginia I-Spine Physicians, Richmond, Virginia) and William Beckworth, M.D. (Emory Orthopaedics & Spine Center, Atlanta, Georgia) report that a single low-dose injection of MPC significantly reduced low back pain in the treated patients and did so at a statistically significant way as compared to the control group.

The control group, by the way, received hyaluronic acid injections. In terms of safety, the researchers found no cell-related safety issues.

The study has enrolled 100 patients across 13 sites in the United States and Australia. Researchers are randomizing patients to receive direct intra-disc injection of saline (n= 20), hyaluronic acid (HA, n=20), 6 million MPCs in hyaluronic acid carrier (n=30) or 18 million MPCs in hyaluronic acid carrier (n=30).

The study participants received their injection in an outpatient setting and only patients with single level degeneration were admitted into the study. The investigators are evaluating the patients for safety and efficacy at 30 days, 3 months and 6 months.

Company officials say that researchers will continue to follow the patients for a total of 36 months to evaluate long-term treatment effects.

At six months, 71% of those patients who received a low dose of MPCs met the pre-specified treatment success criteria. By contrast, only 20% and 30% of the patients in the two control arms who received hyaluronic acid and saline met the pre-specified success criteria.

Mesoblast officials expect to have full trial results by the third quarter this year. Company officials report that confirmation of the interim results supports progression of the study to Phase 3 for MPC treatment of chronic discogenic low back pain.

Over 6 million patients in the United States alone are currently dealing with chronic back pain that has persisted for at least three month, according to Mesoblast’s accounting. The CDC’s National Center for Health Statistics reported in 2010 that low back pain was the leading cause of pain, affecting 28% of American adults. The United States lifetime prevalence of low back pain is estimated to be at least 60-84%.

Total costs of low back pain are estimated to be between $100 billion and $200 billion annually, two-thirds of which are due to decreased wages and productivity.

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26 Responses to “Major Study Update: Stem Cells Ease Back Pain”

  1. betty davis says:

    I am interested in participation of stem cell reseach for my lumbar.

    I live in Florida

    • Yes ,Science is there to start treating the patience that need to get there life back. The opportunity is what holding back thousand of patience. Its knot the money. If they start healing people. The corporation would loose billions of dollars in maintaining peoples pain. I would give every thing I have to get treated and cure of conic back pain. Living on opiates is know fun. Don’t ever give up. Don’t laid in bed. Try to keep your mind and body busy. Pain can be manage. Good luck

  2. Marilyn Rickman says:

    I have Degenerative Disc Disease, horrible pain for over 30 years, living on Percocet to allow myself any function at all.
    How do I get in on one of these trials? I am very interested in stem cell injections.
    I live near Orlando, FL

  3. Julia Hutchison says:

    I’m very interested in this study I’ve been waiting years for stem cell relief…I have nerve damage in all four extremities. Please contact me by email. So excited finally ,I have lived in severe pain since 1996.

    Thank you

  4. I suffer from degenerate disk disease and would like to receive more information on being a candidate for your study
    I am now and have been under the care of a pain management doctor for 16 years, my pain level on a good day is a7 to 8.

  5. L. Benson says:

    I would like information for your Stem Cell Back Injection study. I am a female age 51, I have three disks in my lower back that are paper thin. (MRI results from 2010 and 2013) I am a Florida resident.

  6. John Miller says:

    I am a 49 year old man. I have DDD. How do i get info on being a volunteer for your study. I have tryed everything for the pain with little or no help. My pain man. Doc is from England he told me this treatment is common there. He says it is very affective.

  7. rajbir says:

    what if the back pain due to lumbar disc degeneration is there for more than 7 months, will stem cell inoculation into the disc space be effective?

  8. rajbir says:

    is this system of disc regeneration now applicable on humans as an accepted method to treat a condition like LDD? if yes, i want to know the hospital or center where this treatment is given.
    thankyou.

  9. oh yea, i’ve been suffering from disk problelms for more than 50 years. are you going to do more trials??

  10. Cindy says:

    Please, I would desperately like to be included in your study.

  11. Anna says:

    I have arthritiis in both knees. Had microfracture done in one knee. Tried injection of hyaluronic acid but not very effective. Is there a study on stem cell therapy for arthritis that I can participate?

    • Tin says:

      Hi Anna
      For the knees the stem cell procedure already exists. See regenexx.com
      I had a procedure there with great success. I have back issues as well and waiting for a stem cell procedure on the back

  12. Kalem says:

    Hello, my mom suffers from DDD in her neck and I am trying to help her find a solution. I am very interested in this stem cell research. Please help me understand how we can get involved with any trials or research. She is 34 living in Orlando, FL.

  13. Pino says:

    I have had stem cell treatment for my back and it’s been 10 weeks and still have no relief. It was injected into my back not disc. I have 2 levels of ddd and I’m preying the next injections will be in the middle of my disc. Just need someone to do it.

  14. john berger says:

    Is there any way you can help?
    My name is john; I am 61 years of age,
    I have several vertebrae’s damaged. C 2/3 C 3/4 C 4/5 C 5/6 C 6/7 C 7/T 1 in cervical spine with a titanium plate C 3/4, still pending surgery in the future due to narrowing of the spinal cord and bone growth, in the thoracic spine T 10/11 which cannot be repaired, and in the lumbar spine, L 2-3, L 3-4, L 4-5, L 5-S 1 with a crushed disc pending on the sciatica nerve.
    I live with pain 24/7 from the top of my head, neck, both arms with some numbness, tingling, and in fingers, pain in chest and back, pain in lower spine, pain and numbness in right side of buttock, pain right side of hip, pain in both legs, more so in right leg with numbness and tingling, and pain, numbness and tingling in arch of right foot, and shooting pain into both feet and toes and arch of right foot. My whole body aches 24/7.
    I live with pain depression.
    On Thursday 24/10/2013 I bent down half way and felt sharp pain in my lumbar region, I have been in more pain since. When I lay down the pain subsides quite considerably and when getting up the weight of my body presses on the lumbar region resulting in sharp pain in lumbar spine, and in both hips, cold sensations in upper parts of both legs. Tightness around lumbar region and aching in lower abdomen.
    When sitting it is uncomfortable, I tolerate the pain, but after a while I need to stand up and walk around due to the pain can get quite severe. I do this all day long.
    Bladder control is about 50%, sometimes I can’t make it to the toilet and for number 2, and I have a problem now and then going.
    I have had two reviews from two hospitals. I have seen specialists, and a professor in pain management and they tell me that nothing can be done. I do not want a fusion in the lumbar region, but that is my last option. I have had injections in my lumbar spine. They work only for a short time. I know all my exercises. I have been to physio and hydro therapy. I go down to the ocean so I can float in the ocean and that does help a great deal but only for a short time.
    I have been on all kinds of pain medications but my body seems to react to each and every one of them. At present I am drug free. I do take panamax (up to 8 a day) for my headaches which I have every day, Celebrex 100 mg and 5 to 10 mg of antenex only when it is necessary for me to do so, because if I take them on a regular bases I end up having realistic nightmares. I do have marijuana only at night at home, and that helps me to relax, so I can control the pain, so I can sleep at night.
    I can no longer work due to the back injuries. I can only walk a short distance. I can only stand for a short time or sit for a short time. I need to lie down during the day so I can get of the nerve. The max weight I am allowed to carry is 3 kg only, but at present I can’t carry any weight. I live on a disability support pension.

  15. HD says:

    Florida Orthopaedics Institute in Tampa is offering regenerative medicine/stem cell therapy for those interested in treatment for degenerative disc disease. You’ll need to check to see if they’re participating in trials:
    http://www.floridaortho.com/specialties-services/regenerative-medicine

  16. Angie Nowak says:

    My son just turned 17 and has been involved in hockey, football, and wrestling. Over the years, he has “thrown out” his back and would get routine adjustments. He just had his first MRI, which revealed that he has 5 bulged discs with lots of tears around the sac around the cartilage. He is done with sports forever now and is in pain. His goal now is to lead a functional life. Therapy doesn’t seem to be relieving his pain. My husband and I want to know more about Stem Cell Therapy.

  17. R. Lee Brown says:

    I have suffered with degenerated discs for years with a burning right leg and pain shooting down the other. Along the way, I underwent four back surgeries but left the fusion option on the table, once fusion takes place, there is no return. Being tired of living on pain killers, I heard about, did some research and just this past Friday, traveled to Colorado and had 5 levels injected with my own stem cells taken from my hip bone marrow. It will be three to six months before I can expect any results but I am so sold on the concept, if I get just a little relief, I plan on having it done again. It just makes sense, what better way to heal a body than with your own body.

    • P. McGlone says:

      Lee,
      Have you noticed any results yet from your stem cell therapy you had in Colorado two months ago? I have DDD plus I also have stenosis and can’t stand for more than 10 minutes before I’m in unbearable pain. I’ve thought about checking with the Colorado group about stem cell therapy to see if it might help me.

      • Oscar says:

        Can someone please tell me where I can sign up for the stem cell injections for long term Chronic Pain in my lower back. I am sick of being in pain and taking pain meds!

        I live in the West Palm Beach Area (Florida). I also have good health Insurance that may cover it. Why can’t I find Doctors??

  18. Todd Alea says:

    We have been performing stem cell injections for 3 years…knees are most common, but also cervical and lumbar spine, hips, shoulders, and other joints are done. Success has been very significant.

    • Oscar says:

      I was wondering how your pain is after the injection? I have been living with chronic lower back pain for 10 years and I am sick of it and the pain meds. This IS my last hope.

      I live in West Palm Beach, FL.

      Good Luck!

  19. jeff says:

    my pain mgmt dr is going to do stem cell injections on my L1-L5 on monday. my neurosurgeon does not think fusion is a good idea so this seems like a good alternative…. I hope it works…

  20. debi lynch says:

    interested in any clinical trials open that may help with terrible low back pain right buttock numbness down leg into foot , had spinal fusion dec 2009 L2 w ould like to get back to being active in sports again. constant pain

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