Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back Pain
NCT ID: NCT01290367
Last Updated: 2020-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2011-08-31
2015-07-31
Brief Summary
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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
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Detailed Description
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After the screening and injection visits, each subject will be evaluated clinically and radiographically at 30 days, and again at 3, 6, 12, 24 and 36 months after injection.
Subjects will be evaluated at the same time points for safety.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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High Dose MPCs
Injection of High Dose MPCs with Hyaluronic Acid
Single Dose MPCs Injection
Injection of Low Dose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus.
Single Dose MPCs Injection
Injection of HighDose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus.
Low Dose MPCs
Injection of Low Dose MPCs with Hyaluronic Acid
Single Dose MPCs Injection
Injection of Low Dose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus.
Single Dose MPCs Injection
Injection of HighDose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus.
Saline injection
Injection of saline solution.
Single injection of saline solution
Intradiscal control injection with saline solution
Hyaluronic acid injection
Injection of hyaluronic acid solution
Single injection of hyaluronic acid
Intradiscal control injection with hyaluronic acid
Interventions
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Single Dose MPCs Injection
Injection of Low Dose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus.
Single injection of saline solution
Intradiscal control injection with saline solution
Single injection of hyaluronic acid
Intradiscal control injection with hyaluronic acid
Single Dose MPCs Injection
Injection of HighDose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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) \[per Health Insurance Portability and Accountability Act (HIPAA) privacy ruling in the US\].
4. Have chronic low back pain for at least 6 months.
5. 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.
6. Have failed 3 months of non-operative low back pain management.
7. Disc height loss of \<30% compared to a normal adjacent disc based upon radiographic evaluation.
8. Pre-treatment baseline low back pain of at least 40 mm on a 100 mm visual analog scale.
9. Low back pain greater than leg pain.
10. Pre-treatment baseline Oswestry Disability Index Questionnaire score of at least 30 on the 100-point questionnaire.
Exclusion Criteria
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. Patients with compressive pathology due to stenosis or frankly herniated disc or sequestered discs are not candidates.
4. Intact disc bulge/protrusion or focal herniation at the symptomatic level (s) \> 3 mm or presence of disc extrusion or sequestration.
5. Lumbar spondylitis or other undifferentiated spondyloarthropathy.
6. Have undergone a previous surgery at the involved levels.
7. 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.
8. Have an acute fracture of the spine at the time of enrollment in the study.
9. Have a history of epidural steroid injections within 1 week prior to study treatment.
10. Have a known history of hypersensitivity or anaphylactic reaction to murine or bovine products or dimethyl sulfoxide (DMSO).
11. Have a positive screen for human immunodeficiency virus (HIV) antibodies.
12. Have a known history of hypersensitivity or anaphylactic reaction to Hyaluronan.
13. 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.
14. Have been a recipient of prior stem cell/progenitor cell therapy or other biological intervention to repair the target intervertebral disc.
15. 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.
16. Currently incarcerated (prisoners).
18 Years
ALL
No
Sponsors
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Mesoblast, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Roger Brown
Role: STUDY_DIRECTOR
Mesoblast, Ltd.
Locations
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Arizona Pain Specialists
Scottsdale, Arizona, United States
UC Davis Spine Center
Sacramento, California, United States
The Spine Institute
Santa Monica, California, United States
IPM Medical Group, Inc.
Walnut Creek, California, United States
Denver Spine
Denver, Colorado, United States
Rocky Mountain Associates in Orthopedic Medicine, P.C.
Loveland, Colorado, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States
Central Texas Spine Institute
Austin, Texas, United States
Richmond Bone and Joint Clinic, Memorial Hermann Medical Group
Richmond, Texas, United States
Virginia Spine Research Institute, Inc.
Richmond, Virginia, United States
Washington Center for Pain Management
Edmonds, Washington, United States
The Center for Pain Relief, Inc.
Charleston, West Virginia, United States
Monash Medical Center
Clayton, Victoria, Australia
Countries
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Related Links
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Sponsor Website
Other Identifiers
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MSB-DR001
Identifier Type: -
Identifier Source: org_study_id
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