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

NCT01771471 | Terminated Phase 2 DMC

• 1 other identifier: ISTO-NUQ02-10-12-00
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 10

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.

Conditions

Degenerative Disc Disease

Keywords

back pain; intervertebral disc; lumbar spine

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index

  12 months

Secondary Outcomes (3)

• Subject Satisfaction as measured by subject's willingness to have the same procedure for the same condition

  24 Months

• MRI

  24 Months

• Visual Analog Scale

  24 Months

Study Arms (2)

NuQu treatment

EXPERIMENTAL

single administration

Biological: NuQu

Saline

OTHER

single administration

Other: Placebo

Interventions

NuQu BIOLOGICAL

Allogenic juvenile chondrocytes (NuQu) in fibrin carrier.

NuQu treatment

Placebo OTHER

0.9% w/v Sodium Chloride for Injection, USP

Saline

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• ISTO Technologies, Inc.: lead

Study Sites (10)

Alabama Orthopedic and Spine Center

Birmingham, Alabama, 35235, United States

Location

California Spine Diagnostics

San Francisco, California, 94115, United States

Location

The Spine Institute, Center for Spinal Restoration

Santa Monica, California, 90403, United States

Location

Ortho Georgia

Macon, Georgia, 31210, United States

Location

Tufts University School of Medicine

Newton, Massachusetts, 02458, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Carolina Neurosurgery and Spine Associates

Charlotte, North Carolina, 28204, United States

Location

The NeuroSpine Institute

Eugene, Oregon, 79401, United States

Location

Spine Team Texas

Southlake, Texas, 76092, United States

Location

Spinal Reseach Foundation

Reston, Virginia, 20190, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Domagoj Coric, MD

  Carolina Neurosurgery and Spine Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 18, 2013
• Study Start: November 1, 2012
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: August 31, 2017

Record last verified: 2016-09

Locations

US (10)