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

Phase 2

Terminated

• Conditions: Degenerative Disc Disease
• Interventions: Other: Placebo; Biological: NuQu

• Registration Number: NCT01771471
• Lead Sponsor: ISTO Technologies, Inc.

Brief 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.

Detailed Description

This is a Phase II clinical study to collect additional safety data and preliminary efficiency of juvenile chondrocytes, delivered in fibrin carrier (NuQu®) to the nucleus of lumbar intervertebral discs for the treatment of discogenic pain. This to be accomplished through a double blinded, placebo-controlled study of clinically meaningful endpoints including validated, subject reported outcomes of pain and disability, health related quality of life and subject satisfaction with treatment.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-01-14
• Study First Submitted QC: 2013-01-16
• Study First Posted: 2013-01-18
• Status Verified: 2016-09
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-31
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Placebo	single administration
NuQu treatment	NuQu	single administration

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index	12 months

Secondary Outcome Measures

Name	Time	Method
MRI	24 Months
Subject Satisfaction as measured by subject's willingness to have the same procedure for the same condition	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".
Visual Analog Scale	24 Months

Trial Locations

Locations (10)

Ortho Georgia; 🇺🇸 Macon, Georgia, United States

Carolina Neurosurgery and Spine Associates; 🇺🇸 Charlotte, North Carolina, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Tufts University School of Medicine; 🇺🇸 Newton, Massachusetts, United States

The Spine Institute, Center for Spinal Restoration; 🇺🇸 Santa Monica, California, United States

California Spine Diagnostics; 🇺🇸 San Francisco, California, United States

The NeuroSpine Institute; 🇺🇸 Eugene, Oregon, United States

Spine Team Texas; 🇺🇸 Southlake, Texas, United States

Spinal Reseach Foundation; 🇺🇸 Reston, Virginia, United States

Alabama Orthopedic and Spine Center; 🇺🇸 Birmingham, Alabama, United States