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Tests treatment safety and results for Degenerative Disc Disease
Official title A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease
ClinicalTrials.gov ID: NCT07254806
What this study is testing
What is IDCT (rebonuputemcel)?
IDCT (rebonuputemcel) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for degenerative disc disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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 had low back pain that is unresponsive to at least 3 months of conservative care (nonoperative treatment) to include at least one...
You likely can't join if
- Physical/ Medical History Exclusion Criteria
- 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.
- Leg pain that is of radicular origin, i.e., due to stimulation of nerve roots or dorsal root ganglion of a spinal nerve by compressive forces.
See the full eligibility criteria
- 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 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...
- 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.
- Has pre-treatment ODI score of 35 to 90 at Screening and Day 1.
- 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.
- 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.
- Female-born people 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...
- Physical/ Medical History Exclusion Criteria
- 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.
- Leg pain that is of radicular origin, i.e., due to stimulation of nerve roots or dorsal root ganglion of a spinal nerve by compressive forces.
- Has frequent leg pain that extends below the knee.
- Has severe unilateral or bilateral osteoarthritis of the knee or hip.
- Severe spinal arthritis
- Has cauda equina syndrome.
- Has had previous lumbar spine surgery.
- Has had previous disc invasive treatment procedures (i.e., intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation) or intradiscal injections (i.e., injection of corticosteroids, methylene blue...
- people who have had basivertebral nerve ablation at L3-S1.
- Has clinical suspicion of facet pain as the primary pain generator.
- Has current infection at the planned procedure site, active systemic infection, or current or prior history of lumbar spinal infection (i.e., discitis, septic arthritis, epidural abscess).
- Has a history of fibromyalgia.
- Has tested positive for Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human Immunodeficiency Virus (HIV).
- Has presence of an active malignancy or tumor, or a prior history of malignancy within the last five years (except for basal cell carcinoma of the skin).
- Has presence or prior history of a spinal malignancy.
- Has significant systemic disease, such as unstable angina or autoimmune disease, such as rheumatoid arthritis. Has a history of congenital or acquired coagulopathy or thrombocytopenia. 31\. Is currently taking...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Santa Monica, California, United States
- St. Petersburg, Florida, United States
- Tampa, Florida, United States
- Boise, Idaho, United States
- Post Falls, Idaho, United States
- Carmel, Indiana, United States
- St Louis, Missouri, United States
- Wilmington, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Eugene, Oregon, United States
- Memphis, Tennessee, United States
- Austin, Texas, United States
- Salt Lake City, Utah, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Santa Monica, California, United States; St. Petersburg, Florida, United States; Tampa, Florida, United States; Boise, Idaho, United States; Post Falls, Idaho, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.