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 range
21 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.