Biologic disc treatments

[Crystal33]

Does anyone follow this area of research and know of more treatments out there. Hopefully biologic approach will become common first line treatment in near future.

At present .....

1. nucleus regeneration

a. In use.... Disc Regenerative Therapy | Diagnosis & Treatments | Capitol Spine & Pain Centers®

b. In trial....Intradiscal rhGDF-5
Intradiscal rhGDF-5 Phase I/II Clinical Trial - Full Text View - ClinicalTrials.gov

c. Award winning compound
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2. a. Biologic Anular repair
Phase 3 trial to commence
Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System - Tabular View - ClinicalTrials.gov

Spinal Restoration - Products

(a patient's comments copied from another forum posted as follows. Name/details of person deleted by me.)
“ …I had my 2nd and hopefully last Fibrin injection the first part of February of this year (2009). I worked part time all summer at a hospital and have been working full time since the 2nd of September for ...................... I am doing well. The Fibrin seems to have held this second time. I never thought I would get out of bed again and it seems like a miracle to be working. I work for a bunch of great Spine Doctors. I would certainly try the Fibrin. You don't burn any bridges with it and I do know of people that have gotten relief from it even when their discs were less than 1/3. Some bone on bone almost. The docs I work for know Dr. Pauza and have talked to me a lot about it. I have shown some of them my films and they were amazed I am walking much less working full time. I don't get on here too much anymore because I work a lot but if I can answer any questions I would be more than happy too. I will try to set this up so I get notified if anyone writes. Best wishes and God bless.
XXXXXXXXXXX

10-02 - ProDiscs L4/5 and L5/S1 - FDA study - disks placed incorrectly which
caused problem at L3/4 and L2/3
01-05 - ProDiscs at C5/6 and C6/7 in Germany - seems to be working fine so far
Bedbound from 09-06 until 10-08 due to severe pain and weakness
09-08 - Had Fibrin sealant done at L3/4 and L2/3 After 6 weeks - much success!
Hoping and praying that the lumbar revision surgery that was scheduled with Dr. Regan can be indefinitely postponed ”


b. Mechanical anular repair (not biologic)
Good News For Aching Backs | Article Archive | M.D. News Bay Area Edition

[Crystal33]

Another biologic treatment in trial. Look forward to these approaches starting to replace surgery in near future.

Spine Wave, Inc.

".......Clinical investigations have been designed to demonstrate the potential benefits of the NuCore® Injectable Nucleus, which include pain relief and restoration of the spine’s biomechanics. Patient enrollment in clinical trials for the NuCore® Injectable Nucleus include patients in Switzerland, Germany, Australia and the United States."

[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