Biologic disc treatments

[Crystal33]

2 year outcome of nucore trial

SpringerLink - Journal Article

An injectable nucleus replacement as an adjunct to microdiscectomy: 2 year follow-up in a pilot clinical study

Journal European Spine Journal
Publisher Springer Berlin / Heidelberg
ISSN 0940-6719 (Print) 1432-0932 (Online)
Issue Volume 18, Number 11 / November, 2009
Category Ideas and Technical Innovations
DOI 10.1007/s00586-009-1136-0
Pages 1706-1712
Subject Collection Medicine
SpringerLink Date Tuesday, August 18, 2009

An injectable nucleus replacement as an adjunct to microdiscectomy: 2 year follow-up in a pilot clinical study

Ulrich Berlemann1 Contact Information and Othmar Schwarzenbach1
(1) Spine Center Thun, Bahnhofstrasse 3, Thun, 3600, Switzerland

Received: 9 April 2009 Revised: 21 July 2009 Accepted: 4 August 2009 Published online: 18 August 2009

Abstract Literature indicates that loss of disc tissue from herniation and/or surgery can accelerate degeneration of the disc. The associated loss of disc height may correspond with recurrent back and/or leg pain. A novel hydrogel has been developed to replace lost nucleus pulposus and potentially restore normal disc biomechanics following herniation and surgery. A single-center, non-randomized, prospective feasibility study was undertaken to investigate the use of NuCore® Injectable Nucleus hydrogel (Spine Wave, Inc., Shelton, CT, USA) as a replacement for nuclear tissue lost to herniation and microdiscectomy. Fourteen patients were enrolled at the authors’ hospital as the initial site in a worldwide multicenter pilot study. Subjects who were entered into the study suffered from radicular pain due to single-level herniated nucleus pulposus and were non-respondent to conservative therapy. Following a standard microdiscectomy procedure, the hydrogel material was injected into the nuclear void to replace what tissue had been lost to the herniation and surgery. Leg and back pain, function and disability scores were monitored pre- and post-operatively through 2 years. Neurologic and physical evaluations, blood and serum analyses, and radiographic evaluations of disc height and implant stability were also performed.

Results showed significant improvement for leg and back pain, as well as function scores. No complications or device related adverse events were observed. MR controls confirmed stable position of the implants with no reherniations. Radiographic measurements indicated better maintenance of disc height compared to literature data on microdiscectomy alone. The NuCore® material appears to protect the disc from early collapse following microdiscectomy; and therefore, may have the potential to slow the degenerative cascade of the spinal segment over time.

Keywords Nucleus replacement - Herniation - Hydrogel - Microdiscectomy - NuCore®

Contact Information Ulrich Berlemann
Email: uberlemann@hotmail.com
Email: u.berlemann@dasrueckenzentrum.ch

[Crystal33]

Beginning of oral medication approach to treating disc degeneration....

Diffusion of Human Lumbar Intravertebral Discs can be Enhanced Pharmacologically
With Oral Nimodipine
S. Rajasekaran, Ph.D., J. Naresh Babu, MS K.S. Murugan, MD Ajoy Prasad Shetty, MS
Introduction: Histological studies have documented that Calcium channel antagonist
Nimodipine increases vascularity of end plates in rats. However, there is no corresponding data
for humans and whether endplate hypervascularity leads to increase in diffusion. This prospective
study in human volunteers reports for the first time in literature an increase in diffusion following
Nimodipine by serial post contrast MRI study.
Methods: Forty lumbar end plates of four young healthy male volunteers formed the study
material. The pre-drug diffusion levels were studied by pre and post contrast MRI (0.3 mmol/kg
of gadodiamide) at 10 minutes, two, four, six, 12 and 24 hours. After a gadodiamide wash out
period of 10 days, a plain MR examination was performed to ensure return of signal intensity
values to the base line. Oral Nimodipine was administered (30 mgs QID) for five days following
which diffusion studies were performed by a similar MRI sequence. Enhancement was calculated
at different regions of interest (ROI) - vertebral body- VB; subchondral region-SCB; Endplate
Zone-EPZ and at superior and inferior peripheral nucleus pulposus-PNP and central nucleus
pulposus-CNP, using appropriate cursors by a blinded investigator. Paired sample t-test and area
under curve (AUC) measurements were performed to compare the pre and post-drug signal
intensities.
Results: Nimodipine was found to increase the signal intensity for all ROI significantly pre and
post contrast at all time intervals (p>0.01). The maximum difference in enhancement was at 10
minutes at VB; two hours for SB and EPZ; four hours for PNP and 12 hours for CNP. There was
also a significant increase for AUC at all ROI pre and post nimodipine showing that nimodipine
increases diffusion(p>0.01).
Conclusion: This is the first study to document an increase in diffusion of human lumbar discs
by oral nimodipine and poses interesting possibility of pharmacological enhancement of lumbar
disc diffusion.

[Crystal33]

A current phase III biologic trial is enrolling, if apprpriate for your disc location and pathology.
http://www.lowbackstudy.com/

[Crystal33]

Considering these trials were done on chronic patients, including some with failed backs, you would think that there would have been many follow up double blind placebo trials to confirm the outstanding results from these minimal treatment approaches.
Much more money to be made in open surgery and selling pieces of metal I suppose.
Biochemical injection treatment for discogenic low... [Spine J. 2003 May-Jun] - PubMed result
Treatment of painful advanced internal lumbar disc... [Pain Physician. 2006] - PubMed result

[Crystal33]

Vitamin D anyone?
Back Pain? Vitamin D is a Surprising Champion of Pain Relief, Research Shows - PR.com

[wilsonrob]

Don't forget The Regenexx? Procedure
Dramatic Reduction in Disc Bulge with Disc Stem Cell Injection
LM is a 39 year old male with a 16 year history of severe low back and leg pain. He underwent injection of his own cultured stem cells into his disc bulge. His bulge was very large, so he barely met the study criteria and frankly I wasn’t optimistic about his possibilities, but he was entered into the study largely on the optimism of my partner, Dr. Schultz. Well, LM proved me wrong this week. He is now 7 months post procedure and is 80% better. His films are above. Note the very large disc bulge at the tip of the red arrow on both the before images (top is a saw you in half axial view, bottom left is a side view sagittal). Then note the marked reduction in the size of the disc bulge seen at the tip of the yellow arrow in both matching slices on the right. I have also highlighted the S1 nerve on the axial films (the before and after on the top)-red dot on the before, yellow dot on the left. Note how the disc was pressing on this nerve in the before image and is now far away from the disc in the after. This also corresponds to a reduction in his leg symptoms related to this S1 nerve. Realize all of this was accomplished with only an injection and without surgery. Since this disc bulge had been there for a long time and was worsening before treatment, it’s unlikely this represents spontaneous resolution of this disc.

[BPrice]

Here is info on fibrin injections. This info came from Spine Journal published proceedings (2009; 10S:105S) that are mentioned on the SpinalRestoration website:

This study used pig lumbar spines. To damage the discs, a 19G needle was used to remove 1 ml of nucleus material.

"Nucleotomy produced transient increases in IL-6 and TNF- at 3 weeks that were prevented by fibrin injection. For the no-treatment and fibrin-treated discs, stiffness and leakage pressure were less than control at 3 weeks. Stiffness returned to normal at 6 weeks for the fibrin-treated levels and at 12 weeks for the no-treatment levels. Disc proteoglycan content was less than controls at 3 and 6 weeks for the no-treatment and fibrin-treated levels. GAG content returned to normal at 12 weeks for the fibrin-treated levels, but not for degenerate discs. No adverse cellular reaction to fibrin injection was noted by histology."

I wonder how much less proteoglycan content was in the fibrin-treated levels, and I wonder how the fibrin treatment would fare against a torn disc (as the website states, Biostat "occludes annular fissures"). I don't believe such a claim can be substantiated by this trial.

The SpinalRestoration website mentions an unpublished document named "Fibrin sealant modulates the inflammatory response in intervertebral disc cells." If anyone can find this or any good info on this mode of treatment, please let me know. Thanks.

[lugar]

Hello,

The first thing I must do is apologise for my bad english. I am in Madrid and I have suffered from low back pain for two years. I have intervertebral disc degeneration in L5-S1. I had a treatement with my own cultured stem cells on June 2010. My back and leg pain has improved about 40%, maybe a little more, but I have still problems. My question is about where is possible to get this kind of treatments. For example, where LM did he get it? Do you know which clinics in Europe are doing the treatments? And do you know if they are getting good results?

Thank you. You can ask everything about my treatment if it interests you.

Luis

Originally Posted by wilsonrob

Don't forget The Regenexx? Procedure
Dramatic Reduction in Disc Bulge with Disc Stem Cell Injection
LM is a 39 year old male with a 16 year history of severe low back and leg pain. He underwent injection of his own cultured stem cells into his disc bulge. His bulge was very large, so he barely met the study criteria and frankly I wasn’t optimistic about his possibilities, but he was entered into the study largely on the optimism of my partner, Dr. Schultz. Well, LM proved me wrong this week. He is now 7 months post procedure and is 80% better. His films are above. Note the very large disc bulge at the tip of the red arrow on both the before images (top is a saw you in half axial view, bottom left is a side view sagittal). Then note the marked reduction in the size of the disc bulge seen at the tip of the yellow arrow in both matching slices on the right. I have also highlighted the S1 nerve on the axial films (the before and after on the top)-red dot on the before, yellow dot on the left. Note how the disc was pressing on this nerve in the before image and is now far away from the disc in the after. This also corresponds to a reduction in his leg symptoms related to this S1 nerve. Realize all of this was accomplished with only an injection and without surgery. Since this disc bulge had been there for a long time and was worsening before treatment, it’s unlikely this represents spontaneous resolution of this disc.