Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back Pain

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd.
ClinicalTrials.gov Identifier:
NCT01290367
First received: February 3, 2011
Last updated: March 11, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Degenerative Disc Disease
Biological: Single Dose MPCs Injection
Procedure: Single injection of saline solution
Procedure: Single injection of hyaluronic acid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Mesoblast, Ltd.:

Primary Outcome Measures:
  • 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). [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the change of treated lumbar intervertebral discs using Magnetic Resonance Imaging (MRI) at 6 months post injection of MPCs. [ Time Frame: 6 - 36 Months ] [ Designated as safety issue: No ]
  • To evaluate the effectiveness of MPCs in reducing chronic lumbar back pain using the visual analog scale (VAS). [ Time Frame: 1 - 36 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: July 2015
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Dose MPCs
Injection of High Dose MPCs with Hyaluronic Acid
Biological: Single Dose MPCs Injection
Injection of High Dose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus.
Other Names:
  • Direct MPCs Lumbar Disc Injection.
  • Stem Cells
Experimental: Low Dose MPCs
Injection of Low Dose MPCs with Hyaluronic Acid
Biological: Single Dose MPCs Injection
Injection of Low Dose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus.
Other Names:
  • Direct MPCs Lumbar Disc Injection.
  • Stem Cells
Sham Comparator: Saline injection
Injection of saline solution.
Procedure: Single injection of saline solution
Intradiscal control injection with saline solution
Other Names:
  • Saline injection
  • Sham control
Placebo Comparator: Hyaluronic acid injection
Injection of hyaluronic acid solution
Procedure: Single injection of hyaluronic acid
Intradiscal control injection with hyaluronic acid
Other Names:
  • Hyaluronic acid injection
  • Vehicle control

Detailed Description:

This is a prospective, multicenter, double blinded, controlled clinical study comparing 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 (> 6 months) due to moderate DDD at one lumbar level from L1 to S1 and unresponsive to conservative therapy for at least 3 months (including physical therapy).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or females at least 18 years of age.
  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:

  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. 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290367

Locations
United States, Arizona
Arizona Pain Specialists
Scottsdale, Arizona, United States, 85258
United States, California
UC Davis Spine Center
Sacramento, California, United States, 95816
The Spine Institute
Santa Monica, California, United States, 90403
IPM Medical Group, Inc.
Walnut Creek, California, United States, 94598
United States, Colorado
Denver Spine
Denver, Colorado, United States, 80111
Rocky Mountain Associates in Orthopedic Medicine, P.C.
Loveland, Colorado, United States, 80538
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30329
United States, North Carolina
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States, 28204
United States, Texas
Central Texas Spine Institute
Austin, Texas, United States, 78731
Richmond Bone and Joint Clinic, Memorial Hermann Medical Group
Richmond, Texas, United States, 77469
United States, Virginia
Virginia Spine Research Institute, Inc.
Richmond, Virginia, United States, 23235
United States, Washington
Washington Center for Pain Management
Edmonds, Washington, United States, 98026
United States, West Virginia
The Center for Pain Relief, Inc.
Charleston, West Virginia, United States, 25301
Australia, Victoria
Monash Medical Center
Clayton, Victoria, Australia, 3168
Sponsors and Collaborators
Mesoblast, Ltd.
Investigators
Study Director: Roger Brown Mesoblast, Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Mesoblast, Ltd.
ClinicalTrials.gov Identifier: NCT01290367     History of Changes
Other Study ID Numbers: MSB-DR001
Study First Received: February 3, 2011
Last Updated: March 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mesoblast, Ltd.:
Chronic Lumbar Back Pain
Low back pain
Back pain
Degenerative Disc Disease
Injection of Degenerated Lumbar Disc
Stem Cells
Adult Stem Cells
Allogeneic Mesenchymal Precursor cells (MPCs)
Mesoblast

Additional relevant MeSH terms:
Back Pain
Intervertebral Disc Degeneration
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Pharmaceutical Solutions
Hyaluronic Acid
Therapeutic Uses
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on September 18, 2014