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

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01771471
• Other study ID #: ISTO-NUQ02-10-12-00
• Status: Terminated
• Phase: Phase 2
• First received: January 14, 2013
• Last updated: August 29, 2017
• Start date: November 2012
• Est. completion date: September 2020

Study information

• Verified date: September 2016
• Source: ISTO Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Biological:
• NuQu
Allogenic juvenile chondrocytes (NuQu) in fibrin carrier.

Other:
• Placebo
0.9% w/v Sodium Chloride for Injection, USP

Locations

Country	Name	City	State
United States	Alabama Orthopedic and Spine Center	Birmingham	Alabama
United States	Carolina Neurosurgery and Spine Associates	Charlotte	North Carolina
United States	The NeuroSpine Institute	Eugene	Oregon
United States	Ortho Georgia	Macon	Georgia
United States	Weill Cornell Medical College	New York	New York
United States	Tufts University School of Medicine	Newton	Massachusetts
United States	Spinal Reseach Foundation	Reston	Virginia
United States	California Spine Diagnostics	San Francisco	California
United States	The Spine Institute, Center for Spinal Restoration	Santa Monica	California
United States	Spine Team Texas	Southlake	Texas

Sponsors (1)

Lead Sponsor	Collaborator
ISTO Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index		12 months
Secondary	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
Secondary	MRI		24 Months
Secondary	Visual Analog Scale		24 Months