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The condition being studied is chronic low back or leg pain in patients with internal disc disruption (IDD). The intervention to be studied is the intradiscal delivery of autologous Platelet Rich Plasma (PRP) or bone marrow concentrate (BMC) into the nucleus pulposus of the disrupted disc(s).
This multi-center randomized controlled pilot trial will be the first to evaluate the response of PRP and BMC for discogenic pain by direct comparison. The investigators propose to incorporate a crossover design that compares placebo to two treatment modalities (i.e. Neutrophil-Poor PRP [NP-PRP] and BMC).
If the investigators can demonstrate statistically significant and clinically meaningful improvements in study's primary and secondary outcome measures, this study will have identified a natural, effective and sustainable treatment for discogenic back pain that currently accounts for the highest level of disability in US. This will help guide physicians in the choice of care between surgical and conservative treatment options when treating patients.
Internal Disc Disruption
Intradiscal PRP & BMC Injections
Comprehensive Spine & Sports Center
Comprehensive Spine & Sports Center, Campbell, CA
Published on BioPortfolio: 2019-09-30T07:07:00-0400
A Multicenter, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration
Study to show the safety and tolerability of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration
Study to show the effectiveness and safety of a single injection of rhGDF5 into a degenerating single spinal disc in treating lumbar level degenerative disc disease
Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration.
The purpose of this study is to compare the safety and preliminary efficacy of intradiscal injections of two doses of IDCT (Discogenic Cells + Sodium Hyaluronate vehicle) and one sham cont...
The purpose of this study is to compare two doses of immunoselected, culture-expanded, nucleated, allogeneic adult MPCs when combined with hyaluronic acid to two control intradiscal inject...
Low-pressure Lumbar Provocation Discography According to Spine Intervention Society/International Association for the Study of Pain Standards Does Not Cause Acceleration of Disc Degeneration in Patients with Symptomatic Low Back Pain: A 7 Year Matched Cohort Study.
MINI: This study investigated if low-pressure provocation discography results in accelerated disc degeneration, disc disruption, and disc herniation at long-term follow-up in patients with low back pa...
Discogenic pain is a common cause of disability and is assumed to be a major cause of nonspecific low back pain. Various treatment methods have been used for the treatment of discogenic pain. This stu...
Different transforaminal endoscopic approaches have been developed for the surgical treatment of lumbar disc herniations: Kambin (intradiscal), Yeung (intraforaminal intra-discal), Ruetten (extreme la...
In this case report, we present a novel stabilization technique of the pubic symphysis using an internal spinal fixator in a 78-year-old morbidly obese woman having a pelvic disruption type B1.1 (AO c...
The dissolving of the NUCLEUS PULPOSUS, the semi-gelatinous tissue of a displaced INTERVERTEBRAL DISC. It is usually achieved by the direct injection of a proteolytic enzyme, especially CHYMOPAPAIN, into the herniated disc.
Fibrocartilage inner core of the intervertebral disc. Prolapsed or bulged nucleus pulposus leads to INTERVERTEBRAL DISC DISPLACEMENT while proliferation of cells in the nucleus pulposus is associated with INTERVERTEBRAL DISC DEGENERATION.
Injections into the lymph nodes or the lymphatic system.
Injections introduced directly into localized lesions.
Injections made into a vein for therapeutic or experimental purposes.
An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells. In vertebrates, it is composed of blo...
Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...