Degenerative Disc Disease
Conditions
Keywords
DDD, low back pain, degenerative disc disease
Brief summary
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)
Detailed description
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.
Interventions
BIOLOGICALIDCT (rebonuputemcel)
Single intradiscal injection of 1 mL of 9,000,000 cells/mL IDCT in a single target disc.
OTHERSham (No Treatment)
Single Sham needle insertion up to the annulus of a single target disc.
Sponsors
DiscGenics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
All parties in this trial will be blinded with the exception of the unblinded injecting sub-investigator and their team.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Has a diagnosis of mild to moderate, symptomatic, single-level degenerative disc disease (DDD) from L3-S1. 2. Has a target disc that meets Modified Pfirrmann Grade 3-7, as determined by a central radiologist. 3. 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. 4. Has been experiencing chronic low back pain for at least 6 months prior to Screening. 5. Has had low back pain that is unresponsive to at least 3 months of conservative care (nonoperative treatment) to include at least one non-pharmacological intervention which may include physical therapy, acupuncture, chiropractic manipulation, massage, and at home medically supervised exercise program and two pharmacological interventions which may include NSAIDs, acetaminophen, duloxetine, and/or injectable therapy. 6. Has pre-treatment low back pain score of 45 to 90 on VAS (Visual Analogue Scale) for low back pain at Screening and Day 1. 7. Has pre-treatment ODI score of 35 to 90 at Screening and Day 1. 8. Is willing to voluntarily sign the informed consent form and agrees to the release of previous medical history for purposes of this study (i.e., HIPAA authorization) at Screening. 9. Is physically and mentally able to comply with the protocol, able to understand and complete the required forms, and willing and able to adhere to the requirements of the protocol in the opinion of the Investigator. 10. Female-born subjects of childbearing potential must agree to and comply with using highly effective methods of birth control for the duration of the study (e.g., oral contraceptive, implant, injectable, indwelling intrauterine device, sexual abstinence, condoms, or a vasectomized partner).-
Exclusion criteria
Physical/ Medical History
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) for low back pain | Week 52 | 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) | Week 52 | 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 | Day 1 to Week 52 in each treatment group. | Incidence of grade 2 (moderate) or greater AEs and SAEs |
| Adverse events of special interest | Day 1 to Week 52 in each treatment group | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) | Week 4, 12 and 26, 78 and 104 | 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) | Week 4, 12 and 26, 78 and 105 | 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 | Enrollment through Week 104 | 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 | Day 1 to Week 104 | MRI assessment of Disc Volume though Week 104 |
| Pain Medication Use | Enrollment to Week 104 | Concomitant pain medication use for low back pain related to the target disc |
| Concomitant Therapy | Enrollment to Week 104 | 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 |
| Treatment Failure Rate | Enrollment to week 104 | Treatment failure rate (defined as an invasive non-surgical or surgical intervention) directly related to the target disc. |
| Adverse Events | Enrollment to Week 104 | The incidence of grade 2 (moderate) or greater AEs and SAEs |
| Adverse Events of Special Interest (AESI) | Enrollment to Week 104 | 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. |
Countries
United States
Contacts
STUDY_DIRECTORLisa Flood
DiscGenics, Inc.
Outcome results
None listed