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

Study Overview
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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.

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.

Official Title
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A Phase II, Randomized, Double Blind, Placebo Controlled Study Evaluating the Treatment of Degenerative Lumbar Discs With Allogeneic Cultured Chondrocytes

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Biological: NuQu
* Other: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NuQu treatment<br>single administration | Biological: NuQu<br>* Allogenic juvenile chondrocytes (NuQu) in fibrin carrier.<br>|
| Other: Saline<br>single administration | Other: Placebo<br>* 0.9% w/v Sodium Chloride for Injection, USP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Satisfaction as measured by subject's willingness to have the same procedure for the same condition | 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. | 24 Months | 
| MRI |  | 24 Months | 
| Visual Analog Scale |  | 24 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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back pain, intervertebral disc, lumbar spine