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New treatment option for Disc Degeneration
Official title MDT-0123 Japan Study
ClinicalTrials.gov ID: NCT07414745
What this study is testing
What is MDT-0123?
MDT-0123 is an investigational medicine, being studied as a potential treatment for disc degeneration.
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
- The purpose of this clinical trial is to compare the efficacy and safety of this investigational device with autologous iliac bone graft (ICBG) in patients who are deemed to require bone fusion through spinal fixation at two levels (ALIF or OLIF) due to disc degeneration or spinal deformity in the lumbosacral spine (L2-S1) for intervertebral support and correction with the aim of stabilizing the spine.
- 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 80
You may be able to join if
- Requirement for bone fusion via consecutive 2-level spinal fusion due to disc degeneration or spinal deformity in the lumbosacral spine (L2-S1)
- Symptomatic degenerative lesions from L2 to S1 confirmed by imaging (MRI or myelography within 12 months prior to enrollment) with neurological...
- Degenerative disc disease with discogenic back pain, with or without leg pain, supported by clinical history and radiographic findings (e.g., CT...
- Preoperative Oswestry Disability Index (ODI) score ≥35%
- Skeletally mature
You likely can't join if
- Prior spinal surgery at the target or adjacent intervertebral level, except for decompression procedures such as discectomy
- Inability to complete both investigational device implantation and posterior fixation in a single procedure
- Expected total rhBMP-2 dose greater than 12 mg
- Planned use of an internal or external bone growth stimulator
- Osteoporosis defined as T-score ≤ -2.5 within 12 months with fragility fracture
- Body mass index (BMI) \>40
See the full eligibility criteria
- Requirement for bone fusion via consecutive 2-level spinal fusion due to disc degeneration or spinal deformity in the lumbosacral spine (L2-S1)
- Symptomatic degenerative lesions from L2 to S1 confirmed by imaging (MRI or myelography within 12 months prior to enrollment) with neurological symptoms due to nerve root compression, including radiating pain, sensory...
- Degenerative disc disease with discogenic back pain, with or without leg pain, supported by clinical history and radiographic findings (e.g., CT, MRI, X-ray), with at least one of the following: instability (angular...
- Preoperative Oswestry Disability Index (ODI) score ≥35%
- Skeletally mature
- Age 18 to 80 years at the time of surgery
- Failure to respond to at least 3 months of non-operative treatment (e.g., bed rest, physical therapy, medication, nerve block, manipulation, or transcutaneous electrical nerve stimulation)
- Ability to provide written informed consent after receiving adequate explanation of the study
- Prior spinal surgery at the target or adjacent intervertebral level, except for decompression procedures such as discectomy
- Inability to complete both investigational device implantation and posterior fixation in a single procedure
- Expected total rhBMP-2 dose greater than 12 mg
- Planned use of an internal or external bone growth stimulator
- Osteoporosis defined as T-score ≤ -2.5 within 12 months with fragility fracture
- Body mass index (BMI) \>40
- Active malignancy
- Active local or systemic infection
- Use of bone formation promoting agents within 12 months prior to implantation
- Use of medications that may interfere with bone or soft tissue healing within 30 days prior to implantation, including corticosteroids, antitumor agents, or immunosuppressants
- History of autoimmune diseases affecting bone metabolism or the spine, including ankylosing spondylitis, inflammatory bowel disease, or rheumatoid arthritis
- History of endocrine or metabolic disorders affecting bone formation, including Paget's disease or osteodystrophy
- Prior exposure to modified proteins used for bone formation
- Known hypersensitivity or allergy to device materials or related substances, including titanium, collagen, or protein-based products
- History of severe allergic reactions such as anaphylaxis
- Mental or psychiatric conditions that may interfere with study participation
- Participation in another clinical study within 3 months or planned participation during this study period
- Inability or unwillingness to use appropriate contraception during the study period and for 12 months after implantation
- Presence of spinal tumors in adjacent vertebrae
- Existing or planned implantation of non-study implants in the lumbosacral spine
- Medical conditions that could interfere with evaluation of safety or how well it works, including significant vascular or anatomical abnormalities
- Contraindications to MRI
- Smoking within 12 weeks prior to implantation or unwillingness to abstain during the study period
- Alcohol or substance abuse
- Any condition that, in the investigator's judgment, makes the subject unsuitable for the study
The study team makes the final eligibility decision.
Where it's taking place
- Kobe, Hyōgo, Japan
- Isehara, Kanagawa, Japan
- Higashiosaka, Osaka, Japan
- Koshigaya, Saitama, Japan
- Hamamatsu, Shizuoka, Japan
- Adachi-Ku, Tokyo, Japan
- Minato-Ku, Tokyo, Japan
- Nakano-Ku, Tokyo, Japan
- Shibuya-Ku, Tokyo, Japan
- Shinjuku-Ku, Tokyo, Japan
- Kyoto, Japan
- Osaka, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kobe, Hyōgo, Japan; Isehara, Kanagawa, Japan; Higashiosaka, Osaka, Japan; Koshigaya, Saitama, Japan; Hamamatsu, Shizuoka, Japan; Adachi-Ku, Tokyo, Japan and 6 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.