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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ISTO Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01771471
First received: January 14, 2013
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Degenerative Disc Disease
Biological: NuQu
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double Blind, Placebo Controlled Study Evaluating the Treatment of Degenerative Lumbar Discs With Allogeneic Cultured Chondrocytes

Resource links provided by NLM:


Further study details as provided by ISTO Technologies, Inc.:

Primary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subject Satisfaction as measured by subject's willingness to have the same procedure for the same condition [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    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".

  • MRI [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Visual Analog Scale [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: November 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NuQu treatment
single administration
Biological: NuQu
Allogenic juvenile chondrocytes (NuQu) in fibrin carrier.
Saline
single administration
Other: Placebo
0.9% w/v Sodium Chloride for Injection, USP

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771471

Locations
United States, Alabama
Alabama Orthopedic and Spine Center
Birmingham, Alabama, United States, 35235
United States, California
California Spine Diagnostics
San Francisco, California, United States, 94115
The Spine Institute, Center for Spinal Restoration
Santa Monica, California, United States, 90403
United States, Georgia
Ortho Georgia
Macon, Georgia, United States, 31210
United States, Massachusetts
Tufts University School of Medicine
Newton, Massachusetts, United States, 02458
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
United States, North Carolina
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States, 28204
United States, Oregon
The NeuroSpine Institute
Eugene, Oregon, United States, 79401
United States, Texas
Spine Team Texas
Southlake, Texas, United States, 76092
United States, Virginia
Spinal Reseach Foundation
Reston, Virginia, United States, 20190
Sponsors and Collaborators
ISTO Technologies, Inc.
Investigators
Principal Investigator: Domagoj Coric, MD Carolina Neurosurgery and Spine Associates
  More Information

No publications provided

Responsible Party: ISTO Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01771471     History of Changes
Other Study ID Numbers: ISTO-NUQ02-10-12-00
Study First Received: January 14, 2013
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by ISTO Technologies, Inc.:
back pain
intervertebral disc
lumbar spine

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 20, 2014