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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2020-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Degenerative Disc Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NuQu treatment

single administration

Group Type EXPERIMENTAL

NuQu

Intervention Type BIOLOGICAL

Allogenic juvenile chondrocytes (NuQu) in fibrin carrier.

Saline

single administration

Group Type OTHER

Placebo

Intervention Type OTHER

0.9% w/v Sodium Chloride for Injection, USP

Interventions

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NuQu

Allogenic juvenile chondrocytes (NuQu) in fibrin carrier.

Intervention Type BIOLOGICAL

Placebo

0.9% w/v Sodium Chloride for Injection, USP

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No