A Study Comparing the Safety and Effectiveness of Cartilage Cell Injected Into the Lumbar Disc as Compared to a Placebo

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT01771471

Run by

ISTO Technologies, Inc.

People needed

44

Starts

2012-11-01

Expected to finish

2020-09-01

Last updated by the study team

2017-08-31

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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 opinion may compromise subject participation and/or safety;
• Receiving any immune-suppressant therapies other than short term steroid preparations;
• BMI≥40;
• Diagnosed with any comorbid conditions including: abnormal bleeding, AIDS, diabetes, hepatic or renal disease, and cardiopulmonary disorders such as COPD, MI and CHF; active malignancy or history of malignancy, or diseases of bone metabolism, which in the investigator's opinion may compromise subject participation and/or safety;
• Has a history of alcoholism, medication or intravenous drug abuse, psychosis, is a prisoner, has a personality disorder(s), poor motivation, emotional or intellectual issues that would likely make the subject unreliable for the study, or 3 or more Waddell Signs of nonorganic Behavior or any combination of variables in the Investigator's judgment that should exclude a potential subject;
• Has pending litigation against a health care professional, except where required by the insurer as a condition of coverage, personal injury compensation or litigation claims;
• Has active or pending workers' compensation claims;
• Has contraindications for MRI.

Where it is running

• Alabama Orthopedic and Spine Center — Birmingham, Alabama, United States
• California Spine Diagnostics — San Francisco, California, United States
• The Spine Institute, Center for Spinal Restoration — Santa Monica, California, United States
• Ortho Georgia — Macon, Georgia, United States
• Tufts University School of Medicine — Newton, Massachusetts, United States
• Weill Cornell Medical College — New York, New York, United States
• Carolina Neurosurgery and Spine Associates — Charlotte, North Carolina, United States
• The NeuroSpine Institute — Eugene, Oregon, United States
• Spine Team Texas — Southlake, Texas, United States
• Spinal Reseach Foundation — Reston, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.