Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back Pain
A Prospective, Double Blind, Controlled Study Evaluating Safety and Preliminary Efficacy of a Single Injection of Adult Mesenchymal Precursor Cells (MPCs) Combined With Hyaluronan in Subjects With Chronic Discogenic Lumbar Back Pain
1 other identifier
interventional
100
2 countries
14
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2011
Typical duration for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2011
CompletedFirst Posted
Study publicly available on registry
February 7, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedJune 26, 2020
June 1, 2020
1.9 years
February 3, 2011
June 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
3 years
Secondary Outcomes (2)
To evaluate the change of treated lumbar intervertebral discs using Magnetic Resonance Imaging (MRI) at 6 months post injection of MPCs.
6 - 36 Months
To evaluate the effectiveness of MPCs in reducing chronic lumbar back pain using the visual analog scale (VAS).
1 - 36 Months
Study Arms (4)
High Dose MPCs
EXPERIMENTALInjection of High Dose MPCs with Hyaluronic Acid
Low Dose MPCs
EXPERIMENTALInjection of Low Dose MPCs with Hyaluronic Acid
Saline injection
SHAM COMPARATORInjection of saline solution.
Hyaluronic acid injection
PLACEBO COMPARATORInjection of hyaluronic acid solution
Interventions
Injection of Low Dose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus.
Intradiscal control injection with saline solution
Intradiscal control injection with hyaluronic acid
Eligibility Criteria
You may qualify if:
- 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.
- Low back pain greater than leg pain.
- Pre-treatment baseline Oswestry Disability Index Questionnaire score of at least 30 on the 100-point questionnaire.
You may not qualify if:
- 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.
- Have a history of epidural steroid injections within 1 week prior to study treatment.
- Have a known history of hypersensitivity or anaphylactic reaction to murine or bovine products or dimethyl sulfoxide (DMSO).
- Have a positive screen for human immunodeficiency virus (HIV) antibodies.
- Have a known history of hypersensitivity or anaphylactic reaction to Hyaluronan.
- 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.
- Have been a recipient of prior stem cell/progenitor cell therapy or other biological intervention to repair the target intervertebral disc.
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mesoblast, Ltd.lead
Study Sites (14)
Arizona Pain Specialists
Scottsdale, Arizona, 85258, United States
UC Davis Spine Center
Sacramento, California, 95816, United States
The Spine Institute
Santa Monica, California, 90403, United States
IPM Medical Group, Inc.
Walnut Creek, California, 94598, United States
Denver Spine
Denver, Colorado, 80111, United States
Rocky Mountain Associates in Orthopedic Medicine, P.C.
Loveland, Colorado, 80538, United States
Emory University School of Medicine
Atlanta, Georgia, 30329, United States
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, 28204, United States
Central Texas Spine Institute
Austin, Texas, 78731, United States
Richmond Bone and Joint Clinic, Memorial Hermann Medical Group
Richmond, Texas, 77469, United States
Virginia Spine Research Institute, Inc.
Richmond, Virginia, 23235, United States
Washington Center for Pain Management
Edmonds, Washington, 98026, United States
The Center for Pain Relief, Inc.
Charleston, West Virginia, 25301, United States
Monash Medical Center
Clayton, Victoria, 3168, Australia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Roger Brown
Mesoblast, Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2011
First Posted
February 7, 2011
Study Start
August 1, 2011
Primary Completion
July 1, 2013
Study Completion
July 1, 2015
Last Updated
June 26, 2020
Record last verified: 2020-06