This is a Phase III, randomized, double-blinded, Sham-controlled, multi-center study in subjects with single-level, symptomatic lumbar (L3- S1) intervertebral disc degeneration. The study will have a 52-week primary period followed by 52 week Follow-up Period (total of 104 weeks). The study protocol will be approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC), and the study will be conducted in accordance with Good Clinical Practice (GCP). All subjects will provide written informed consent prior to Screening. Approximately 162 subjects will be enrolled in the study. Up to 45 days prior to treatment, subjects will be screened for study inclusion, which includes obtaining baseline MRI and X-ray imaging. Imaging results for subjects initially eligible for study participation will be sent to a central imaging vendor for review and confirmation of eligibility, including the number of levels with degeneration. Subjects meeting all inclusion/exclusion criteria will be assigned to the corresponding treatment arm group and subsequently randomized to IDCT or Sham. Randomization will occur approximately 7 to 14 days prior to the scheduled treatment administration date. Overall, 162 subjects will be enrolled and randomized to IDCT or Sham in a 2:1 ratio. * IDCT (n=108) * Sham (n=54)
Adult subjects with a diagnosis of single-level, mild to moderate, symptomatic lumbar (L3-S1) intervertebral disc degeneration that give consent and meet all the inclusion criteria and none of the exclusion criteria will be enrolled in this study. The disease, single-level disc will be known as the 'target disc' and will be either L3/L4, L4/L5, or L5/S1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
162
Single intradiscal injection of 1 mL of 9,000,000 cells/mL IDCT in a single target disc.
Single Sham needle insertion up to the annulus of a single target disc.
Injury Care Family Care Research
Boise, Idaho, United States
RECRUITINGAxis Spine Center
Post Falls, Idaho, United States
RECRUITINGThe Orthopedic Center of St. Louis
St Louis, Missouri, United States
RECRUITINGWake Research
Wilmington, North Carolina, United States
RECRUITINGCarolinas Pain Institute/ Center For Clinical Research
Winston-Salem, North Carolina, United States
RECRUITINGSemmes Murphey Neurological Clinic
Memphis, Tennessee, United States
RECRUITINGVisual Analogue Scale (VAS) for low back pain
VAS is a sliding visual scale of 0 being "no pain" and 100 being "worst pain Imaginable' to assess changesfrom baseline in low back pain compared to Sham
Time frame: Week 52
Oswestry Disability Index (ODI)
ODI is a 10-item questionnaire used to measure functional disability in people with low back pain. It is a self-administered tool that assesses how back pain affects daily activities like walking, sleeping, and personal hygiene, with scores ranging from 0% (no disability) to 100% (maximum disability).
Time frame: Week 52
Adverse Events
Incidence of grade 2 (moderate) or greater AEs and SAEs
Time frame: Day 1 to Week 52 in each treatment group.
Adverse events of special interest
Incidence of Adverse Events of Special Interest (AESI) to include any symptomatic injury of the target disc including annular tear, disc herniation/extrusion/prolapse as well as discitis.
Time frame: Day 1 to Week 52 in each treatment group
Visual Analogue Scale (VAS)
VAS is a sliding visual scale of 0 being "no pain" and 100 being "worst pain Imaginable' to assess changes from baseline in low back pain
Time frame: Week 4, 12 and 26, 78 and 104
Oswestry Disability Index (ODI)
ODI is a 10-item questionnaire used to measure functional disability in people with low back pain. It is a self-administered tool that assesses how back pain affects daily activities like walking, sleeping, and personal hygiene, with scores ranging from 0% (no disability) to 100% (maximum disability).
Time frame: Week 4, 12 and 26, 78 and 105
EQ-5D
EQ-5D is a validated too consisting of a set of questions covering five dimensions, with each dimension having a different severity level. 1. Mobility: Ranging from "no problems walking about" to "confined to bed". Self-care: Ranging from "no problems with self-care" to "unable to wash or dress myself". 2. Usual activities: Ranging from "no problems doing my usual activities" to "unable to do my usual activities" (e.g., work, study, housework). 3. Pain/discomfort: Ranging from "no pain or discomfort" to "extreme pain or discomfort". 4. Anxiety/depression: Ranging from "not anxious or depressed" to "extremely anxious or depressed". 5. Visual Analog Scale (EQ VAS): A scale (typically 0-100) where respondents mark their overall health from "worst imaginable" to "best imaginable".
Time frame: Enrollment through Week 104
Disc Volume
MRI assessment of Disc Volume though Week 104
Time frame: Day 1 to Week 104
Pain Medication Use
Concomitant pain medication use for low back pain related to the target disc
Time frame: Enrollment to Week 104
Concomitant Therapy
Concomitant medical therapy for low back pain (physical therapy, acupuncture, chiropractic manipulation, massage, and at-home, medically supervised exercise program etc.) use for low back pain
Time frame: Enrollment to Week 104
Treatment Failure Rate
Treatment failure rate (defined as an invasive non-surgical or surgical intervention) directly related to the target disc.
Time frame: Enrollment to week 104
Adverse Events
The incidence of grade 2 (moderate) or greater AEs and SAEs
Time frame: Enrollment to Week 104
Adverse Events of Special Interest (AESI)
The incidence of Adverse Events of Special Interest (AESI) observed defined as any one of the followings symptomatic injury of the target disc including annular tear, disc, herniation/extrusion/prolapse or any case of discitis.
Time frame: Enrollment to Week 104
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