Clinical trial NCT01771471: A Study Comparing the Safety and Effectiveness of Cartilage Cell Injected Into the Lumbar Disc as Compared to a Placebo
Official title: A Phase II, Randomized, Double Blind, Placebo Controlled Study Evaluating the Treatment of Degenerative Lumbar Discs With Allogeneic Cultured Chondrocytes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Degenerative Disc Disease
Keywords: back pain
intervertebral disc
lumbar spine
Lead sponsor: ISTO Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-18
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: 12 months
Secondary outcomes:
measure: Subject Satisfaction as measured by subject's willingness to have the same procedure for the same condition
timeFrame: 24 Months
measure: MRI
timeFrame: 24 Months
measure: Visual Analog Scale
timeFrame: 24 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Orthopedic and Spine Center
state: Alabama
city: San Francisco
country: United States
facility: California Spine Diagnostics
state: California
city: Santa Monica
country: United States
facility: The Spine Institute, Center for Spinal Restoration
state: California
city: Macon
country: United States
facility: Ortho Georgia
state: Georgia
city: Newton
country: United States
facility: Tufts University School of Medicine
state: Massachusetts
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Charlotte
country: United States
facility: Carolina Neurosurgery and Spine Associates
state: North Carolina
city: Eugene
country: United States
facility: The NeuroSpine Institute
state: Oregon
city: Southlake
country: United States
facility: Spine Team Texas
state: Texas
city: Reston
country: United States
facility: Spinal Reseach Foundation
state: Virginia
Study officials:
affiliation: Carolina Neurosurgery and Spine Associates
name: Domagoj Coric, MD
role: PRINCIPAL_INVESTIGATOR
References: