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)
Has a diagnosis of mild to moderate, symptomatic, single-level degenerative disc disease (DDD) from L3-S1.
Has a target disc that meets Modified Pfirrmann Grade 3-7, as determined by a central radiologist.
Is ≥18 and ≤75 years of age, skeletally mature, and has a body mass index (BMI) ≥18 kg/m2 and ≤38 kg/m2 at Screening.
Has been experiencing chronic low back pain for at least 6 months prior to Screening.
Has low back pain that in the Investigator's opinion is predominately myofascial in nature.
Has constant, unchanging low back pain that is not improved in any spinal position.
Has radiculopathy resulting from nerve compression.
Has non-radicular unilateral or bilateral leg pain with intensity greater than 50% of the intensity of the low-back pain, as measured by VAS.
Parallel
IDCT (rebonuputemcel)
Biological/VaccineSingle intradiscal injection of 1 mL of 9,000,000 cells/mL IDCT in a single target disc.
Sham (No Treatment)
Other interventionSingle Sham needle insertion up to the annulus of a single target disc.
Visual 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
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).
Adverse Events
Incidence of grade 2 (moderate) or greater AEs and SAEs
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.
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
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).
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".
Disc Volume
MRI assessment of Disc Volume though Week 104
MRI Based evaluations
MRI Evaluation of the lumbar spine will be reported as an aggregate in one report to assess of disc height, Modified Pfirrmann grade, Modic changes, annular tears/fissures, endplate integrity, herniation, and any additional noteworthy observations at 12, 26, 52, 78, and 104.
X-ray evaluation of the lumbar spine
X-ray evaluation of flexion/extension will be assessed and measure in degrees of angles.
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