Degenerative Disc Disease Clinical Trial
Official title:
A Prospective, Multicenter, Randomized, Open-Label, Controlled Study Evaluating Safety and Preliminary Efficacy of NeoFuse When Combined With Mastergraft Granules in Subjects Undergoing Posterolateral Lumbar Fusion With Instrumentation
Verified date | June 2020 |
Source | Mesoblast, Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate safety and preliminary efficacy of Neofusetm in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1 and undergoing posterolateral lumbar fusion.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Male or females at least 18 years of age, but not older than 70. 2. Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol. 3. 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]. 4. Have a documented symptomatic diagnosis of DDD at L1-S1 with or without stenosis and with or without up to and including Grade II degenerative spondylolisthesis 5. Have clinical symptoms of neurogenic claudication. 6. Have failed 6 months of non-operative low back pain management. 7. Are candidates for lumbar interbody fusion with autograft in combination with posterolateral fusion and require surgery at a 1 or 2 adjacent vertebral levels between L1 and S1 8. Have a stable screening electrocardiogram (ECG), as determined by the investigator that would not preclude surgery - Exclusion Criteria: 1. Female subjects who are pregnant or nursing, or women planning to become pregnant during the first year (12 months) following surgery. 2. Have a current or prior history within the last 3 years of neoplasm (excluding basal cell carcinoma) and/or any active neoplasm within the last 24 months, prior to screening. 3. Have osteoporosis as defined by a DEXA T score of = -3.5 or a history of fragility fractures or other significant bone disease contraindicating the use of spinal instrumentation. 4. Have a documented medical history or radiographic evidence of a metabolic bone disease or other condition which would negatively impact the bone healing process. 5. Have a positive screen for human immunodeficiency virus (HIV) antibodies 6. Have had treatment with any investigational therapy or device within 6 months of study surgery and/or plans to participate in any other allogeneic stem cell/progenitor cell therapy trial during the 3-year follow-up period. 7. Have been a recipient of prior stem cell/progenitor cell therapy for spinal fusion surgery. 8. Have a body mass index (BMI) > 35. 9. Have 20% or greater anti-human leukocyte antigen (HLA) antibody titer and/or has antibody specificities to donor HLA antigens. 10. 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. - |
Country | Name | City | State |
---|---|---|---|
United States | Texas Back Institute | Plano | Texas |
Lead Sponsor | Collaborator |
---|---|
Mesoblast, Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the safety of NeoFuse (allogeneic mesenchymal precursor cells [MPCs] when combined with MasterGraft Resorbable Ceramic granules as a carrier for posterolateral lumbar fusion (PLF) with instrumentation | 3 years | ||
Secondary | To evaluate the overall fusion success with NeoFuse plus carrier compared to autograft using CT scans and x-ray of the involved lumbar spine levels and access the change in outcomes (ODI, SF-36) and pain (VAS) | 3 years |
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