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

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ClinicalTrials.gov Identifier: NCT01771471
Recruitment Status : Terminated (Change in clinical strategy)
First Posted : January 18, 2013
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
ISTO Technologies, Inc.

Tracking Information
First Submitted Date  ICMJE January 14, 2013
First Posted Date  ICMJE January 18, 2013
Last Update Posted Date August 31, 2017
Study Start Date  ICMJE November 2012
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2013)
Oswestry Disability Index [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2013)
  • Subject Satisfaction as measured by subject's willingness to have the same procedure for the same condition [ Time Frame: 24 Months ]
    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 ]
  • Visual Analog Scale [ Time Frame: 24 Months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing the Safety and Effectiveness of Cartilage Cell Injected Into the Lumbar Disc as Compared to a Placebo
Official Title  ICMJE A Phase II, Randomized, Double Blind, Placebo Controlled Study Evaluating the Treatment of Degenerative Lumbar Discs With Allogeneic Cultured Chondrocytes
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Degenerative Disc Disease
Intervention  ICMJE
  • Biological: NuQu
    Allogenic juvenile chondrocytes (NuQu) in fibrin carrier.
  • Other: Placebo
    0.9% w/v Sodium Chloride for Injection, USP
Study Arms  ICMJE
  • Experimental: NuQu treatment
    single administration
    Intervention: Biological: NuQu
  • Saline
    single administration
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 16, 2013)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01771471
Other Study ID Numbers  ICMJE ISTO-NUQ02-10-12-00
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ISTO Technologies, Inc.
Study Sponsor  ICMJE ISTO Technologies, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Domagoj Coric, MD Carolina Neurosurgery and Spine Associates
PRS Account ISTO Technologies, Inc.
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP