A Study Comparing the Safety and Effectiveness of Cartilage Cell Injected Into the Lumbar Disc as… (NCT01771471) | Clinical Trial Compass
TerminatedPhase 2
A Study Comparing the Safety and Effectiveness of Cartilage Cell Injected Into the Lumbar Disc as Compared to a Placebo
Stopped: Change in clinical strategy
United States44 participantsStarted 2012-11
Plain-language summary
This is a clinical study to collect safety and preliminary efficiency information on the use of NuQu chondrocytes (cartilage cells) delivered to the center of a lumbar spinal disc to treat low back pain.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject is able to provide informed consent and must sign the Institutional Review Board approved Informed Consent Form;
* Is at least 21 years of age;
* Have central low back pain aggravated by movement and or postural changes (standing/sitting);
* Have had back pain for at least 6 months, and have failed conservative management
* One Grade III or IV (Pfirrmann Scale) degenerated lumbar disc;
Exclusion Criteria:
* Current disc extrusion at any level in their lumbar spine; disc bulges or protrusions at any level in the lumbar spine resulting in nerve root compression;
* Severe disc narrowing (equal to or more than 50% loss of disc height at the targeted level);
* Type II or III Modic changes at any level;
* Type I Modic changes at any level other than the targeted level;
* Type I Modic changes at the treated level if maximum height of the changes is 25% or more of the vertebral body height;
* Osteoporotic compression fracture at any vertebral level;
* Lumbar Scheurmann's disease;
* Antero or retrolisthesis ≥ 3mm at any level;
* Currently experiencing chronic pain generating from any other source, which (in the judgment of the investigator) may interfere with the evaluation of back pain, and or disability;
* Infection at the planned treatment site, history of systemic or local infection, which (in the investigator's judgment) may compromise subject participation and/or safety;
* Currently diagnosed with immune-deficiency, which in the investigator's op…