Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumb… (NCT01290367) | Clinical Trial Compass
CompletedPhase 2
Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back Pain
United States100 participantsStarted 2011-08
Plain-language summary
The purpose of this study is to compare two doses of immunoselected, culture-expanded, nucleated, allogeneic adult MPCs when combined with hyaluronic acid to two control intradiscal injections in subjects with chronic low back pain due to moderate Degenerative Disc Disease (DDD) at one lumbar level from L1 to S1.
All investigational subjects in this study will undergo injection of either 6 million (M) or 18M cells in a hyaluronic acid carrier into the degenerated lumbar disc's nucleus pulposus. All control subjects will undergo an intradiscal control injection with either saline or hyaluronic acid only
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or females at least 18 years of age.
✓. 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) \[per Health Insurance Portability and Accountability Act (HIPAA) privacy ruling in the US\].
✓. Have chronic low back pain for at least 6 months.
✓. Have documented symptomatic diagnosis of DDD of one level from L1-S1 as determined by a change in disc hydration on MRI compared to normal disc with or without an annular fissure or a contained disc herniation.
✓. Have failed 3 months of non-operative low back pain management.
✓. 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.
Exclusion criteria
What they're measuring
1
To determine the overall safety of MPCs plus carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests (hematology, serum chemistry, inflammation, and immunology).
✕. Female subjects who are pregnant or nursing, or women planning to become pregnant during the first year (12 months) following surgery.
✕. 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.
✕. 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.
✕. Lumbar spondylitis or other undifferentiated spondyloarthropathy.
✕. Have undergone a previous surgery at the involved levels.
✕. 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.