Health Facts

Back pain is often caused by obesity

Most people know that obesity contributes to the development of various diseases. However, did you know that obesity is a contributing factor to back pain? It is true. Being overweight or obese can significantly contribute to  osteoporosis, osteoarthritis, rheumatoid arthritis, degenerative disc disease, spinal stenosis, and spondylolisthesis.

Introduction to Regenerative Biologic Therapies

Low back pain caused by damaged discs in the spine affects millions of people every year.  In most instances, discogenic pain is treated with conservative therapies such as bed rest, physical therapy and pain medications. When these treatments are no longer effective, patients may undergo a surgical procedure such as fusion or artificial disc replacement. There are no widely accepted, non-surgical therapies for treating discogenic chronic low back pain.

Leaders in the field of spinal and disc disorders are now changing their focus towards regenerative biologic therapies for these damaged discs.  These therapies are tested through FDA studies.

Dr. Hyun Bae of The Spine Institute in Santa Monica and The Spine Center at Cedars Sinai Medical Center is the primary investigator for FDA studies for injectable biologic therapies to treat damaged discs in the spine.

Active enrollment is occurring for the studies listed below:

Clinical Trial:
Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System.

Active enrollment status: OPEN

Investigator(s):  

Website: http://clinicaltrials.gov/ct2/show/NCT01011816?term=biostat&rank=1

Description:    The Biostat System is a combination product combining a resorbable biologic product with a delivery device system used to prepare and insert the biologic material into a lumbar intervertebral disc.

Regenerative Biologic Therapies

Above is an illustration of the Biostat System applied to a Degenerated Disc

Symptomatic IDD is defined as a painful disruption of the internal architecture of a lumbar intervertebral disc, which appears as fissures, cracks or tears within the internal structures of the disc. Pain arising from a lumbar disc may not only be perceived as pain located in the low back (axial pain) but also as somatic referred pain involving the posterior hips, buttocks, lateral hips, groin, or posterior thighs.

x-ray of an L5-S1 Disc Pre Biostat injection, and Post Biostat injection

The image above is an x-ray of an L5-S1 Disc Pre Biostat injection, and Post Biostat injection.  The yellow line identifies the change in volume of the disc before and after the injection.

Clinical Trial:
Intradiscal rhGDF-5 Phase I/II Clinical Trial Discs

Active enrollment status: OPEN

Investigator(s):  

Website: http://clinicaltrials.gov/ct2/show/NCT00813813

Description:    The study drug is called rhGDF-5, a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and it influences the growth and differentiation of various tissues, including the intervertebral disc.  Participants in the study will be followed for approximately 36 months (visits for the first 12 months post-treatment and via annual telephone contact at months 24 and 36 post-treatment).

Regenerative Biologic Therapies

Injection of rhGDF5 into a degenerating spinal disc to study the treatment of lumbar level degenerative disc disease

Are you a Candidate?

These studies are currently recruiting participants.

To find out if you are a candidate, please call 310 828-7757 to schedule an appointment with one of our spine specialists.