Mesoblast (Adult Stem Cell) Disc Repair Clinical Trial Inclusion/Exclusion Criteria
Subjects who meet the following criteria will be included in the Mesoblast Adult Stem Cell disc repair study:
- Males or females at least 18 years of age and skeletally mature. If a woman is of childbearing potential (not amenorrheic for the previous 24 months or not surgically sterile), then she must:
- Have a confirmed negative serum pregnancy test result at screening and a negative urine pregnancy test result before procedure and the administration of the study product if performed more than 7 days of after screening.
- Agree to use a medically approved method of contraception for at least 1 year after procedure.
Male subjects with partners of childbearing potential must agree to use adequate contraception (barrier method or abstinence) from the time of procedure and for a period of at least 1 year after procedure.
- Have documented symptomatic diagnosis of moderate DDD at one level from L1 to S1. Symptomatic moderate DDD is defined as the following:
- Chronic low back pain for at least 6 months.
- Have failed 3 months of non-operative low back pain management. (These conservative treatment regimens may include initial rest, massage, acupuncture, chiropractic manipulations, activity modification, physical therapy, home-directed lumbar exercise program and non-invasive pain control treatments or procedures).
- Have undergone supervised physical therapy, such as daily walking routines, therapeutic exercises, and back education programs.
- Change from normal disc morphology as defined by MRI evaluation.
- Patients with a modified Pfirmann score of 3, 4, 5 or 6 (see Radiographic Evaluation Protocol for criteria and examples).
- Modic Grade II changes or less.
- With or without contained disc herniations up to a 3mm protrusion with no radiographic evidence of neurological compression.
- Disc height loss of <30% compared to a normal adjacent disc based upon radiographic evaluation.
- Pre-treatment baseline low back pain of at least 40 mm on a 100 mm visual analog scale.
- Leg pain, if present:
- Is no greater than 50% of low back pain as measured on a visual analog scale. If bilateral leg pain existed, the worst leg pain is no greater than 50% of low back pain.
- Is nonradicular origin, i.e., not due to stimulation of nerve roots or dorsal root ganglion of a spinal nerve by compressive forces.
- Does not extend below the knee
- Pre-treatment baseline Oswestry Disability Index Questionnaire score of at least 30 on the 100-point questionnaire.
- Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
- Have the ability to understand and provide written authorization for the use and disclosure of personal health information (PHI) [per Health Insurance Portability and Accountability Act (HIPAA) privacy ruling in the US or applicable regulations outside the US].
Subjects will be excluded from participating in the study if they meet any of the following
- Female subjects who are pregnant or nursing, or women planning to become pregnant during the first year (12 months) following procedure.
- Modified Pfirmann score of 1 & 2 or 7 & 8 (see Radiographic Evaluation Protocol for criteria & examples).
- Clinically significant nerve or sacroiliac joint pain.
- Clinically significant facet pain as determined by a diagnostic medial branch block or facet joint injection between 18 months and 2 weeks prior to the study procedure to rule out facet joint involvement.
- Symptomatic involvement of more than one lumbar disc level.
- Patients with compressive pathology due to stenosis or frankly herniated disc or sequestered discs are not candidates.
- Intact disc bulge/protrusion or focal herniation at the symptomatic level(s) > 3 mm or presence of disc extrusion or sequestration.
- Discs with full thickness tears with free flowing contrast through the annulus fibrosis that would allow the injected MPCs to extrude from the disc as confirmed through injection of contrast into the target disc.
- Lumbar intervertebral foraminal stenosis at the affected level(s) resulting in clinically significant spinal nerve root compression.
- Symptomatic central vertebral canal or lateral recess stenosis.
- Suspected symptomatic facet joints at the index level or adjacent segments.
- Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI > 40).
- Spondylolisthesis and spondylolysis.
- Lumbar spondylitis or other undifferentiated spondyloarthropathy.
- Clinically relevant instability on flexion-extension as determined by the investigator by overlaying films.
- Have undergone a previous surgery at the involved level that may have altered the target disc (e.g. discectomy, laminectomy, foraminotomy, fusion, intradiscal electrothermal therapy,intradiscal radiofrequency thermocoagulation etc.).
- Any lumbar intradiscal injection procedure (e.g., injection of corticosteroids, methylene blue, dextrose, or glucosamine and chondroitin sulfate). Discography may be performed, but must be done at least 2 weeks or more prior to the MPC injection procedure.
- Have an acute fracture of the spine at the time of enrollment in the study. Clinically compromised vertebral bodies at the affected level due to current or past trauma, e.g., sustained pathological fracture or multiple fractures of vertebrae.
- Have a history of epidural steroid injections within 1 week prior to study treatment.
- Have received chronic (more than 7 consecutive days) treatment with systemic corticosteroids at a dose equivalent to prednisone ≥ 10 mg/day within 14 days prior to injection procedure.
- Have received systemic or local nonsteroidal anti-inflammatory drugs (NSAIDS) injections into the index and/or adjacent vertebral levels within 48 hours prior to study procedure.
- Have a known history of hypersensitivity or anaphylactic reaction to murine or bovine products or dimethyl sulfoxide (DMSO).
- Have a known history of hypersensitivity or anaphylactic reaction to products from birds, such as feathers, eggs or poultry.
- Have a known history of hypersensitivity or anaphylactic reaction to Hyaluronan.
- Have a current or prior history within the last 5 years of neoplasm (excluding resected basal cell carcinoma) and/or any active neoplasm within the last 60 months, prior to screening.
- Have a positive screen for human immunodeficiency virus (HIV) by antibodies or nucleic acid test.
- Have had treatment with any investigational therapy or device as of 6 months of study procedure and/or plans to participate in any other allogeneic stem cell/progenitor cell therapy trial during the 3-year follow-up period.
- Have been a recipient of prior stem cell/progenitor cell therapy or other biological intervention to repair the target intervertebral disc.
- Are at higher risk for post-surgical bleeding (e.g., bleeding disorder or taking anticoagulants except low dose aspirin) or post-surgical infection (e.g., taking immunosuppressants, have a severe infection or a history of serious infection).
- Have a medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study or potentially decrease survival or interfere with ambulation or rehabilitation (e.g., histories of transient ischemic attack (TIA), stroke, uncontrolled diabetes, autoimmune disease, muscular dystrophy, rheumatoid arthritis or liver disease).
- Not a candidate for posterior injection of the intervertebral disc.
- Active malignancy or tumor as source of symptoms.
- Current infection or prior history of spinal infection at the treatment level (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection.
- Body habitus precludes adequate fluoroscopic visualization for the procedure or the procedure is physically impossible due to inability to inject the nucleus pulposus.
- Presence of ferromagnetic implants that would disallow MRI of the symptomatic disc(s).
- Abnormal lumbar neurological exam at baseline (e.g., chronic radiculopathy).
- Currently incarcerated (prisoners).
- Are transient or has been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an inpatient substance abuse program.
- Unable to complete follow-up according to the protocol.
- Have a mental illness that could prevent completion of the study or protocol questionnaires.
- Have a life expectancy of less than 5 years.
To apply for this stem cell study, complete our application form.