Degenerative Disc Disease
Conditions
Keywords
back pain, intervertebral disc, lumbar spine
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.
Interventions
BIOLOGICALNuQu
Allogenic juvenile chondrocytes (NuQu) in fibrin carrier.
OTHERPlacebo
0.9% w/v Sodium Chloride for Injection, USP
Sponsors
ISTO Technologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oswestry Disability Index | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction as measured by subject's willingness to have the same procedure for the same condition | 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 | 24 Months | — |
| Visual Analog Scale | 24 Months | — |
Countries
United States
Outcome results
None listed