A Study Comparing the Safety and Effectiveness of Cartilage Cell Injected Into the Lumbar Disc as Compared to a Placebo
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ClinicalTrials.gov Identifier: NCT01771471 |
Recruitment Status :
Terminated
(Change in clinical strategy)
First Posted : January 18, 2013
Last Update Posted : August 31, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Degenerative Disc Disease | Biological: NuQu Other: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 44 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase II, Randomized, Double Blind, Placebo Controlled Study Evaluating the Treatment of Degenerative Lumbar Discs With Allogeneic Cultured Chondrocytes |
Study Start Date : | November 2012 |
Estimated Primary Completion Date : | September 2020 |
Estimated Study Completion Date : | September 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: NuQu treatment
single administration
|
Biological: NuQu
Allogenic juvenile chondrocytes (NuQu) in fibrin carrier. |
Saline
single administration
|
Other: Placebo
0.9% w/v Sodium Chloride for Injection, USP |
- Oswestry Disability Index [ Time Frame: 12 months ]
- Subject Satisfaction as measured by subject's willingness to have the same procedure for the same condition [ Time Frame: 24 Months ]Success to be measured by the response of "Definitely True" or "Mostly True" to the following: "All things considered I would have the treatment again for the same condition".
- MRI [ Time Frame: 24 Months ]
- Visual Analog Scale [ Time Frame: 24 Months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771471
United States, Alabama | |
Alabama Orthopedic and Spine Center | |
Birmingham, Alabama, United States, 35235 | |
United States, California | |
California Spine Diagnostics | |
San Francisco, California, United States, 94115 | |
The Spine Institute, Center for Spinal Restoration | |
Santa Monica, California, United States, 90403 | |
United States, Georgia | |
Ortho Georgia | |
Macon, Georgia, United States, 31210 | |
United States, Massachusetts | |
Tufts University School of Medicine | |
Newton, Massachusetts, United States, 02458 | |
United States, New York | |
Weill Cornell Medical College | |
New York, New York, United States, 10065 | |
United States, North Carolina | |
Carolina Neurosurgery and Spine Associates | |
Charlotte, North Carolina, United States, 28204 | |
United States, Oregon | |
The NeuroSpine Institute | |
Eugene, Oregon, United States, 79401 | |
United States, Texas | |
Spine Team Texas | |
Southlake, Texas, United States, 76092 | |
United States, Virginia | |
Spinal Reseach Foundation | |
Reston, Virginia, United States, 20190 |
Principal Investigator: | Domagoj Coric, MD | Carolina Neurosurgery and Spine Associates |
Responsible Party: | ISTO Technologies, Inc. |
ClinicalTrials.gov Identifier: | NCT01771471 |
Other Study ID Numbers: |
ISTO-NUQ02-10-12-00 |
First Posted: | January 18, 2013 Key Record Dates |
Last Update Posted: | August 31, 2017 |
Last Verified: | September 2016 |
back pain intervertebral disc lumbar spine |
Intervertebral Disc Degeneration Spinal Diseases Bone Diseases Musculoskeletal Diseases |