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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose MPCs | Experimental | Injection of High Dose MPCs with Hyaluronic Acid |
|
| Low Dose MPCs | Experimental | Injection of Low Dose MPCs with Hyaluronic Acid |
|
| Saline injection | Sham Comparator | Injection of saline solution. |
|
| Hyaluronic acid injection | Placebo Comparator | Injection of hyaluronic acid solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Dose MPCs Injection | Biological | Injection of Low Dose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger Brown | Mesoblast, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Pain Specialists | Scottsdale | Arizona | 85258 | United States | ||
| UC Davis Spine Center |
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|
| Single injection of saline solution | Procedure | Intradiscal control injection with saline solution |
|
|
| Single injection of hyaluronic acid | Procedure | Intradiscal control injection with hyaluronic acid |
|
|
| Single Dose MPCs Injection | Biological | Injection of HighDose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus. |
|
|
| 1 - 36 Months |
| 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 |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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