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Regenexx Licensed Disc Technology Gets FDA Approval for Phase 2 Trial for Stem Cell Back Treatment

POSTED ON IN Back/lumbar Latest News BY Chris Centeno

stem cell back treatment

Many years ago we were the first physicians on earth to enter the world of stem cell back treatment by injecting stem cells into low-back discs. We eventually learned what did and didn’t work and licensed our technology to a small publically traded company called BioRestorative Therapies (BRTX). That group spent about 18 months performing extensive preclinical trials using our disc stem cell technology and was just granted permission by the US FDA to begin in phase 2 trials (skipping phase 1). I’d like to share with you some history of how all of that came about as we’re excited here at Regenexx that one of our procedures is entering FDA trials.

The BRTX Press Release

BioRestorative Therapies Receives FDA Clearance to Initiate Phase 2 Clinical Trial for the Treatment of Patients with Degenerative Disc Disease

MELVILLE, N.Y., February 8, 2017 – BioRestorative Therapies, Inc. (“BRT” or the “Company”) (BRTX), a life sciences company focused on stem cell-based therapies, today announced that it has received clearance by the U.S. Food and Drug Administration (FDA) to commence a Phase 2 clinical trial using its lead cell therapy candidate, BRTX-100, to treat chronic lower back pain due to degenerative disc disease related to protruding/bulging discs.

The Phase 2 clinical trial is a 72 patient, randomized, double-blind, controlled, multi-center study designed to evaluate safety and efficacy of a single dose of BRTX-100 in treating chronic lower lumbar disc disease. BRTX-100 will be administered via intradiscal injection into one disc of a subject with chronic lumbar disc disease and whose pain is not responsive to conservative treatment measures (e.g., oral medication, epidural injections and physical therapy).  The primary goal of the treatment is to both reduce pain and increase function in these patients.

In January 2017, the Company had submitted an Investigational New Drug Application (IND) to the FDA to obtain clearance to commence this clinical trial using BRTX-100. BRTX-100 is a product formulated using a patient’s own cell population (autologous), which consists of hypoxic (low oxygen) cultured mesenchymal stem cells (MSCs) that are optimized for specific use for a non-surgical, conservative intradiscal procedure that can be performed in a physician’s office.

“We are excited to be able to begin our clinical development of BRTX-100 with this Phase 2 clinical trial,” said Mark Weinreb, President and Chief Executive Officer of BioRestorative Therapies. “This treatment has the potential to positively impact millions of Americans suffering from chronic lumbar disc disease as an alternative to surgery.  We believe that this technology can be truly transformative and addresses a large market underserved by current therapies.”

Our Experience with Stem Cell Back Treatment

When we began our stem cell injection work in 2005, it was due to animal research showing that mesenchymal stem cells injected into a degenerated disc could significantly heal that disc. That was exciting enough to get us into regenerative medicine when no other physician in the US even knew what it was. However, when we met with experts who were treating athletic horses at the time, they had no insights in how to deal with low-back discs as horses didn’t get such treatments in 2005. Hence, we began treating both low-back discs and joints in the same way. The low-back-disc patients were almost uniformly a complete failure, while the joint stem cell treatments were working. We then went back to the drawing board on discs and dramatically changed how we culture expanded cells and our technique for implanting them.

In 2007–2008 we had a stem cell back treatment breakthrough. A novel culture method for stem cells and our new procedure that we used to place the cells into the right spot began to show that we could reduce the size of disc bulges on follow-up MRI. By 2013 we had enough experience to license this technology to a new publically traded company called BioRestorative Therapies. The company worked diligently to raise funds and then ultimately began pre-IND work with the FDA in 2014. Their most recent press release is above.

The fact that BRTX got FDA approval to skip phase 1 trials is both a testament to the incredibly detailed preclinical animal work they were able to perform as well as the fact that this autologous cell therapy has been used in humans since 2006. The paper I covered on this blog a few weeks ago allowed the company to show the FDA that the issue with this therapy wasn’t likely to be safety.

The upshot? I’m incredibly proud to have pioneered a stem cell back treatment that is finally beginning phase 2 FDA trials. Congrats to Mark Weinreb and Franciso Silva and the rest of the BRTX team! My colleague Greg Lutz, MD, from H.S.S. has been chosen to lead their clinical research team for these trials, and I have full confidence that Greg will be able to bring “my baby” home to full FDA approval!

    *DISCLAIMER: Like all medical procedures, Regenexx® Procedures have a success and failure rate. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else.
    Providers listed on the Regenexx website are for informational purposes only and are not a recommendation from Regenexx for a specific provider or a guarantee of the outcome of any treatment you receive.

    comments

    Robin says

    Great news. Congrats all!
    One question I have though is why is that all the trials / studies focus on lumber discs and that they are none (that I've seen) addressing the cervical (or even thoracic) regions. I realize that the lumber disc is larger and easier and safer to access but can you point to any current trials / studies outside the lumber area. Also, is it safe to assume that if the procedure shows promise in reducing lumber disc bulges , will it also reduce cervial disc bulges as well and why or why not.

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    Chris Centeno says

    Robin,
    Yes, we are slowing moving into treating cervical discs as well.

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    Sarah Klein says

    Where are you with the hip treatment that is done out the US?? My husband is interested but unwilling to fly out of the country

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    Chris Centeno says

    Sarah,

    That will continue to be done in Grand Cayman.

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    David Karris says

    Boy I wish I could have this treatment done to me, I have been suffering from low back pain for over 10 years. I just had another MRI and cat scan going Monday 02/13/17 for xrays. Even had a spinal ablation which did not work. Currently on Celecoxib 200mg. and after working 43 out 60 year's of my lift I am now on disability.

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    Chris Centeno says

    Sorry to hear that, David. This particular treatment is specifically for certain types of bulging low back discs and uses your own "cultured" stem cells, which is why it requires FDA approval. The good news is, we use a wide array of same day stem cell procedures to treat back pain successfully that don't require FDA approval, because your stem cells are not cultured. Please see: http://www.regenexx.com/the-regenexx-procedures/back-surgery-alternative/

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    Donna Manning says

    Congrats! As a stockholder and patient I am proud of your advances.

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    Chris Centeno says

    Thanks Donna!

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    DIANE FAY says

    Congratulations !!!
    and Thank you! As a Patient... I can't tell you enough times how glad I am ...to have found you all.

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    Chris Centeno says

    Thanks Diane!

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    Darren says

    Where do you get the stem cells

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    Chris Centeno says

    Darren,
    The bone marrow stem cells are harvested from your Iliac crest, which is the back of your hip. Please see: http://www.regenexx.com/doctor-stem-cell-expert-or-novice-bma/

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    Lydia Pineiro says

    Is this available in So. Florida? If so, where? Thanks

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    Chris Centeno says

    Lydia,

    We have a Regenexx provider in South Florida that does all our other spinal procedures. http://ocyonregenerative.com/ However this particular procedure is done only in Grand Cayman.

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    Tabitha says

    Hello,
    Would love to be a part of this trial. Can you direct me where to apply?

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    Chris Centeno says

    Tabitha,
    Don't have that information but The Hospital for Special Surgery In New York City might have some information.

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    Kimberly Armstrong says

    Are stem cells a viable option for severe debilitating back pain after 2 spinal fusions? My husband has failed all conservative treatments to include injections and ablations and now he is being offered a third fusion plus the surgeon wants to fuse 2 areas in his cervical spine. We want to avoid surgery and just manage the pain. Thank you

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    Chris Centeno says

    Kimberly,
    Generally, the answer is not another fusion, as that becomes an ongoing cycle. Because a fusion prevents movement in the fused area, the lack of movement puts more stress on and overloads the vertebrae above and below the fused levels causing pain, breakdown, bone spurs and degenerative arthritis. Please see: https://www.regenexx.com/pain-after-back-fusion-adjacent-segment-disease/ Abalation (RFA) kills the nerve which is needed to stabilize the area, so it too complicates the situation. https://www.regenexx.com/burn-nerves-in-low-back/ We'd need a current MRI and an exam to see if we can help. To do that, please submit the Candidate form.

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    Chris says

    Congratulations! Thank you for your continued dedication to producing high quality evidence based data in this field with many "Murky" unscrupulous players!

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    About the Author

    Chris Centeno

    Christopher J. Centeno, M.D. is an international expert and specialist in regenerative medicine and the clinical use of mesenchymal stem cells in orthopedics. He is board certified in physical medicine as well as rehabilitation and in pain management through The American Board of Physical Medicine and Rehabilitation.…

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