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

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

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.

Study Overview

• Status: Terminated
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Biological: NuQu; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Orthopedic and Spine Center
  • California
    • San Francisco, California, United States, 94115
      • California Spine Diagnostics
    • Santa Monica, California, United States, 90403
      • The Spine Institute, Center for Spinal Restoration
  • Georgia
    • Macon, Georgia, United States, 31210
      • Ortho Georgia
  • Massachusetts
    • Newton, Massachusetts, United States, 02458
      • Tufts University School of Medicine
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolina Neurosurgery and Spine Associates
  • Oregon
    • Eugene, Oregon, United States, 79401
      • The NeuroSpine Institute
  • Texas
    • Southlake, Texas, United States, 76092
      • Spine Team Texas
  • Virginia
    • Reston, Virginia, United States, 20190
      • Spinal Reseach Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: ISTO Technologies, Inc.
• Investigators: Principal Investigator: Domagoj Coric, MD, Carolina Neurosurgery and Spine Associates

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: January 14, 2013
• First Submitted That Met QC Criteria: January 16, 2013
• First Posted (Estimate): January 18, 2013

Study Record Updates

• Last Update Posted (Actual): August 31, 2017
• Last Update Submitted That Met QC Criteria: August 29, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: back pain; intervertebral disc; lumbar spine
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: ISTO-NUQ02-10-12-00

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No