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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
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This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or combined with hyaluronic acid (HA) in participants with chronic low back pain (> 6 months) associated with moderate radiographic degenerative changes of a disc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rexlemestrocel-L | Experimental | Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with saline on Day 0 (Visit 2). |
|
| Rexlemestrocel-L + HA | Experimental | Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with hyaluronic acid (HA) solution on Day 0 (Visit 2). |
|
| Placebo | Placebo Comparator | Participants received saline solution as matching-placebo on Day 0 (Visit 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rexlemestrocel-L | Drug | Rexlemestrocel-L injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Treatment Success: Bayesian Estimated Response Rate | Overall treatment success was determined based on number of responders who had composite response at both months 12 and 24 evaluated per specified criteria. A treatment responder with treatment success was defined as a participant who met the 3 criteria of a composite responder analysis as: 50% or greater reduction in the lower-back pain visual analogue scale (VAS) score; 15-point or greater reduction in the Oswestry Disability Index (ODI) score; and lack of post-treatment interventions at the treated level as of the study visit (Visits 6 [12 months post-treatment] and 8 [24 months post-treatment]). The average response rate (proportion of participants with response presented as Bayesian estimate[BE]) was based upon the average of multiple Bayesian simulations. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness Based on Pain Responders: Bayesian Estimated Response Rate | A participant was defined as a pain responder for a given study visit if they achieved at least a 50% reduction from Baseline in the lower-back pain VAS score (average pain over 24 hours), as reported during in-clinic assessment. The participant should be qualified as a pain responder at both 12 and 24 months post-treatment, and must not have received a post-treatment intervention through 24 months' follow-up. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Low Back Pain Visual Analog Scale (VAS) Score at 1, 3, 6, 12, 18, 24, and 36 Months | Pain intensity was recorded on a horizontal 100 mm VAS and measured as the distance in millimeters from the left origin of the horizontal VAS line and the point indicated by the participant as representing their level of pain. A horizontal 100 mm VAS anchored on the left with the words "No Pain" and on the right with the words "Worst Possible Pain", was used to measure low back pain intensity. Scores were obtained by measuring the distance in millimeters from the left origin of the line (0) to the point indicated with a slash placed by the participant to indicate the participant's level of pain. VAS ranges from 0 to 100, with higher scores indicating worst possible pain. A negative change from baseline indicates improvement. |
Inclusion Criteria:
Male and female participants 18 years of age and older
If female of childbearing potential, participant is non-pregnant, non-nursing, and agrees to use highly effective methods of contraception for a minimum of 24 months post-treatment
Signed informed consent and country-appropriate privacy forms indicating participant is willing to undergo treatment and willing to be available for each examination scheduled over the study duration
Have documented diagnosis of moderate radiographic degeneration of an intervertebral disc from L1 to S1, with a disc suspected of causing chronic low back pain (CLBP) associated with moderate radiographic degeneration at a lumbar disc is defined as the following (participant must meet all of the listed conditions):
A modified Pfirrmann score of 3, 4, 5 or 6 on magnetic resonance imaging (MRI) at the index disc
Modic Grade II changes or less on MRI at the index disc
With or without contained disc protrusion at the index disc on MRI
e. Low back pain of at least 40mm and not more than 90mm of 100mm on low back pain visual analogue scale (VAS) (average pain over 24 hours)
f. Leg pain ≤20mm in both legs on a 100mm VAS scale
g. Oswestry disability index (ODI) score of at least 30 and no more than 90 on a 100 point scale.
Exclusion Criteria:
Female participants who are pregnant or nursing, or women planning to become pregnant in the first 24 months post-treatment
Extreme obesity, as defined by National Institutes of Health (NIH) Clinical Guidelines Body Mass Index (BMI > 40)
Have undergone a surgical procedure (e.g. discectomy, intradiscal electrothermal therapy, intradiscal radiofrequency, artificial disc replacement, interbody fusion) on the disc at the index or adjacent level
Osteoporosis, as defined by dual-energy X-ray absorptiometry (DEXA) scan. A DEXA T-score of ≤ -2.5 will exclude the participant.
Any lumbar intradiscal injection, including steroids, into the index or adjacent discs prior to treatment injection, with the exception of the following injections performed at least 2 weeks prior to study treatment:
Have undergone a procedure affecting the structure/biomechanics of the index disc level (e.g., posterolateral fusion)
Active malignancy or tumor as source of symptoms or history of malignancy within the 5 years prior to enrolment on study
Have been a recipient of prior allogeneic stem cell/progenitor cell therapy for any indication or autologous stem cell/progenitor cell therapy or other biological intervention to repair the index intervertebral disc
An average baseline morphine equivalent dose (MED) of >75mg/day as determined by e-diary entries during the screening period
Taking systemic immunosuppressants
A medical condition, serious intercurrent illness, or extenuating circumstance that would preclude participation in the study or potentially decrease survival or interfere with ambulation or rehabilitation.
Participants involved in spinal litigation, including workman's compensation, unless litigation is complete
Are transient or has a severe alcohol or substance abuse problem
Clinically significant nerve pain (e.g., chronic radiculopathy or neuropathy)
Clinically significant sacroiliac joint pain
Compressive pathology due to stenosis or disc protrusion on MRI with associated clinical symptoms defined as leg pain VAS>20mm out of 100mm or neurologic deficit on neurologic exam
Disc extrusion with a maximum dimension greater or equal to twice the posterior height of the disc, or disc sequestration in the lumbar spine on MRI as determined by radiographic core lab
Modified Pfirrmann score of 7 or 8 at any lumbar level (L1-S1) on MRI evaluation as determined by radiographic core lab
Symptomatic involvement of more than one lumbar disc
Symptomatic central vertebral canal stenosis as defined by neurogenic claudication
Spondylolisthesis or retrolisthesis Grade 2 and above or Spondylolysis at the index or adjacent level(s)
Lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index disc
Spinal deformity defined as lumbar scoliosis with a Cobb angle of the lumbar spine greater than 15 degrees
Any fracture of the spine at the index or adjacent levels that has not healed, or clinically compromised vertebral bodies at the index level due to current or past trauma
Facet pain at the index level or adjacent segments as determined by a diagnostic medial branch block (a facet block injection is not acceptable for making this determination) to rule out facet joint involvement.
Full thickness annular tears in the index level as determined by free flowing contrast media through the annulus fibrosis.
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| Name | Affiliation | Role |
|---|---|---|
| Roger Brown | Mesoblast, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35235 | United States | ||
| Tennessee Valley Pain Consultants |
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Starting on March 6, 2015, a total of 404 participants were enrolled at investigative sites in Australia and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rexlemestrocel-L | Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with saline on Day 0 (Visit 2). |
| FG001 | Rexlemestrocel-L + HA |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2018 |
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| Rexlemestrocel-L + HA Mixture |
| Drug |
Rexlemestrocel-L was combined in 1:1 by-volume ratio with HA solution and the resulting mixture was injected |
|
| Placebo | Drug | Saline control solution |
|
| Up to 24 months |
| Effectiveness Based on Functional Responders: Bayesian Estimated Response Rate | A participant was defined as a functional responder for a given study visit if they achieved at least a 15-point reduction from Baseline in ODI score, as reported during in-clinic assessment. The participant should be qualified as a functional responder at both 12 and 24 months post-treatment, and must not have received a post-treatment intervention through 24 months' follow-up; any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations. | Up to 24 months |
| Effectiveness Based on Treatment Success at 24 Months: Bayesian Estimated Response Rate | A treatment responder with treatment success was defined as a participant who met the 3 conditions of a composite responder analysis as: 50% or greater reduction in the lower-back pain VAS score; 15-point or greater reduction in ODI score; and lack of post-treatment interventions at the treated level as of the study visit. The participants qualified as responders if they satisfied the above conditions at the 24-month follow-up visit alone. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations. | Month 24 |
| Effectiveness Based on Minimal Pain Responders at 24 Months: Bayesian Estimated Response Rate | A minimal pain responder was defined as a participant who achieved a lower-back pain VAS score (average pain over 24 hours) of 20 mm or less at the given study visit. The participants qualified as responders if they satisfied the above condition at 24 months post-treatment, and did not receive a post-treatment intervention through 24 months' follow-up. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations. | Month 24 |
| Effectiveness Based on Time to First Intervention Over 24 Months | The effectiveness of the study drug was evaluated based on its ability in increasing the time to additional interventions at the treated level over 24 months post-treatment. Kaplan-Meier estimates for the probability (expressed as a percentage) of participants to receive an intervention are presented. | Up to Month 24 |
| Effectiveness Based on Minimal Disability Responders at 24 Months: Bayesian Estimated Response Rate | A minimal disability responder was defined as a participant who achieved an ODI score of 20% or less at the given study visit. The participants qualified as responders if they satisfied the above condition at 24 months post-treatment, and did not receive a post-treatment intervention through 24 months' follow-up. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations. | Month 24 |
| Months 1, 3, 6, 12, 18, 24, and 36 |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Arizona Pain Specialists | Scottsdale | Arizona | 85258 | United States |
| Physicians Research Group | Tempe | Arizona | 85284-2604 | United States |
| TriWest Research Associates, LLC | El Cajon | California | 92020-4124 | United States |
| Memorial Orthopaedics Surgical Group | Long Beach | California | 90806 | United States |
| Newport Beach Headache and Pain | Newport Beach | California | 92660 | United States |
| Institute for Regenerative Medicine and Clinical Research | Pasadena | California | 91105 | United States |
| UC Davis Spine Center | Sacramento | California | 95816 | United States |
| Orthopedic Pain Specialists | Santa Monica | California | 90403 | United States |
| The Spine Institute | Santa Monica | California | 90403 | United States |
| Summit Pain Alliance | Santa Rosa | California | 95401 | United States |
| Integrated Pain Management | Walnut Creek | California | 94598 | United States |
| Denver Back Pain Specialists, LLC | Greenwood Village | Colorado | 80111 | United States |
| George Washington University Medical Center | Washington D.C. | District of Columbia | 20037 | United States |
| Coastal Clinical Research Specialists | Fernandina Beach | Florida | 32034 | United States |
| Shrock Orthopedic Research, LLC | Fort Lauderdale | Florida | 33316 | United States |
| Holy Cross Orthopedics Institute | Oakland Park | Florida | 33334 | United States |
| Emory Orthopaedics & Spine Center | Atlanta | Georgia | 30329 | United States |
| Georgia Institute for Clinical Research, LLC | Marietta | Georgia | 30060 | United States |
| Injury Care Medical Center | Boise | Idaho | 83713 | United States |
| Millennium Pain Center | Bloomington | Illinois | 61701 | United States |
| Otrimed Clinical Research | Edgewood | Kentucky | 41017 | United States |
| Orthopedic Specialists of Louisiana | Shreveport | Louisiana | 71103 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| MAPS Applied Research Center | Shakopee | Minnesota | 55379 | United States |
| Innovative Pain Care Center | Las Vegas | Nevada | 89129 | United States |
| University Clinical Research | Somerset | New Jersey | 08873 | United States |
| Ainsworth Institute of Pain Management | New York | New York | 10022 | United States |
| Rochester Regional Health | Rochester | New York | 14626 | United States |
| Carolina Neurosurgery and Spine Associates | Charlotte | North Carolina | 28204 | United States |
| On Site Clinical Solutions, LLC | Morrisville | North Carolina | 28117 | United States |
| The Center for Clinical Research/ Carolinas Pain Institute | Winston-Salem | North Carolina | 27103 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44106 | United States |
| DOC Clinical Research | Dayton | Ohio | 45432 | United States |
| Clinical Investigations, LLC | Edmond | Oklahoma | 73013 | United States |
| Orthopaedic and Spine Specialists | York | Pennsylvania | 17402 | United States |
| RI Hospital-Comprehensive Spine Center | Providence | Rhode Island | 02903 | United States |
| Clinical Trials of South Carolina | Charleston | South Carolina | 29406 | United States |
| Greenville Pharmaceutical Research, Inc. | Charleston | South Carolina | 29406 | United States |
| Texas Back Institute | Plano | Texas | 75093 | United States |
| Spine Team Texas | Southlake | Texas | 76092 | United States |
| Precision Spine Care | Tyler | Texas | 75701 | United States |
| Ericksen Research & Development, LLC | Bountiful | Utah | 84010 | United States |
| the SMART Clinic | Draper | Utah | 84020 | United States |
| Hope Research Institute | St. George | Utah | 84790 | United States |
| Virginia iSpine Physicians, PC | Richmond | Virginia | 23235 | United States |
| Monash Medical Center | Clayton | Victoria | 3168 | Australia |
Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with hyaluronic acid (HA) solution on Day 0 (Visit 2).
| FG002 | Placebo | Participants received saline solution as matching-placebo on Day 0 (Visit 2). |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Intent-to-treat (ITT) Analysis Set included all participants who were randomized, regardless of whether or not the participant was treated, or post-treatment measures were performed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rexlemestrocel-L | Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with saline on Day 0 (Visit 2). |
| BG001 | Rexlemestrocel-L + HA | Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with HA solution on Day 0 (Visit 2). |
| BG002 | Placebo | Participants received saline solution as matching-placebo on Day 0 (Visit 2). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Treatment Success: Bayesian Estimated Response Rate | Overall treatment success was determined based on number of responders who had composite response at both months 12 and 24 evaluated per specified criteria. A treatment responder with treatment success was defined as a participant who met the 3 criteria of a composite responder analysis as: 50% or greater reduction in the lower-back pain visual analogue scale (VAS) score; 15-point or greater reduction in the Oswestry Disability Index (ODI) score; and lack of post-treatment interventions at the treated level as of the study visit (Visits 6 [12 months post-treatment] and 8 [24 months post-treatment]). The average response rate (proportion of participants with response presented as Bayesian estimate[BE]) was based upon the average of multiple Bayesian simulations. | The ITT Analysis Set included all participants who were randomized, regardless of whether or not the participant was treated, or post-treatment measures were performed. | Posted | Mean | Standard Deviation | BE proportion of participants | Up to 24 months |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Effectiveness Based on Pain Responders: Bayesian Estimated Response Rate | A participant was defined as a pain responder for a given study visit if they achieved at least a 50% reduction from Baseline in the lower-back pain VAS score (average pain over 24 hours), as reported during in-clinic assessment. The participant should be qualified as a pain responder at both 12 and 24 months post-treatment, and must not have received a post-treatment intervention through 24 months' follow-up. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations. | The ITT Analysis Set included all participants who were randomized, regardless of whether or not the participant was treated, or post-treatment measures were performed. | Posted | Mean | Standard Deviation | BE proportion of participants | Up to 24 months |
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| Secondary | Effectiveness Based on Functional Responders: Bayesian Estimated Response Rate | A participant was defined as a functional responder for a given study visit if they achieved at least a 15-point reduction from Baseline in ODI score, as reported during in-clinic assessment. The participant should be qualified as a functional responder at both 12 and 24 months post-treatment, and must not have received a post-treatment intervention through 24 months' follow-up; any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations. | The ITT Analysis Set included all participants who were randomized, regardless of whether or not the participant was treated, or post-treatment measures were performed. | Posted | Mean | Standard Deviation | BE proportion of participants | Up to 24 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Effectiveness Based on Treatment Success at 24 Months: Bayesian Estimated Response Rate | A treatment responder with treatment success was defined as a participant who met the 3 conditions of a composite responder analysis as: 50% or greater reduction in the lower-back pain VAS score; 15-point or greater reduction in ODI score; and lack of post-treatment interventions at the treated level as of the study visit. The participants qualified as responders if they satisfied the above conditions at the 24-month follow-up visit alone. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations. | The ITT Analysis Set included all participants who were randomized, regardless of whether or not the participant was treated, or post-treatment measures were performed. | Posted | Mean | Standard Deviation | BE proportion of participants | Month 24 |
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| Secondary | Effectiveness Based on Minimal Pain Responders at 24 Months: Bayesian Estimated Response Rate | A minimal pain responder was defined as a participant who achieved a lower-back pain VAS score (average pain over 24 hours) of 20 mm or less at the given study visit. The participants qualified as responders if they satisfied the above condition at 24 months post-treatment, and did not receive a post-treatment intervention through 24 months' follow-up. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations. | The ITT Analysis Set included all participants who were randomized, regardless of whether or not the participant was treated, or post-treatment measures were performed. | Posted | Mean | Standard Deviation | BE proportion of participants | Month 24 |
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| Secondary | Effectiveness Based on Time to First Intervention Over 24 Months | The effectiveness of the study drug was evaluated based on its ability in increasing the time to additional interventions at the treated level over 24 months post-treatment. Kaplan-Meier estimates for the probability (expressed as a percentage) of participants to receive an intervention are presented. | The ITT Analysis Set included all participants who were randomized, regardless of whether or not the participant was treated, or post-treatment measures were performed. | Posted | Number | percentage probability | Up to Month 24 |
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| Secondary | Effectiveness Based on Minimal Disability Responders at 24 Months: Bayesian Estimated Response Rate | A minimal disability responder was defined as a participant who achieved an ODI score of 20% or less at the given study visit. The participants qualified as responders if they satisfied the above condition at 24 months post-treatment, and did not receive a post-treatment intervention through 24 months' follow-up. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations. | The ITT Analysis Set included all participants who were randomized, regardless of whether or not the participant was treated, or post-treatment measures were performed. | Posted | Mean | Standard Deviation | BE proportion of participants | Month 24 |
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| Other Pre-specified | Mean Change From Baseline in Low Back Pain Visual Analog Scale (VAS) Score at 1, 3, 6, 12, 18, 24, and 36 Months | Pain intensity was recorded on a horizontal 100 mm VAS and measured as the distance in millimeters from the left origin of the horizontal VAS line and the point indicated by the participant as representing their level of pain. A horizontal 100 mm VAS anchored on the left with the words "No Pain" and on the right with the words "Worst Possible Pain", was used to measure low back pain intensity. Scores were obtained by measuring the distance in millimeters from the left origin of the line (0) to the point indicated with a slash placed by the participant to indicate the participant's level of pain. VAS ranges from 0 to 100, with higher scores indicating worst possible pain. A negative change from baseline indicates improvement. | The ITT Analysis Set included all participants who were randomized, regardless of whether or not the participant was treated, or post-treatment measures were performed. Number analyzed is the number of participants with data available for analysis at the given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Months 1, 3, 6, 12, 18, 24, and 36 |
|
Up to approximately 38 months
All-cause Mortality: The ITT Analysis Set included all participants who were randomized, regardless of whether or not the participant was treated, or post-treatment measures were performed. Serious and Other (Non-serious) Adverse Events: Safety Analysis Set included all participants who were randomized and received treatment, and classified according to the actual treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rexlemestrocel-L | Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with saline on Day 0 (Visit 2). | 0 | 143 | 17 | 140 | 111 | 140 |
| EG001 | Rexlemestrocel-L + HA | Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with hyaluronic acid (HA) solution on Day 0 (Visit 2). | 0 | 129 | 15 | 128 | 100 | 128 |
| EG002 | Placebo | Participants received saline solution as matching-placebo on Day 0 (Visit 2). | 0 | 132 | 10 | 130 | 98 | 130 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Escherichia bacteremia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Perineurial cyst | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Sacral radiculopathy | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Spinal meningeal cyst | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Biliary dyskinesia | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hepatic hematoma | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Device breakage | Product Issues | MedDRA 22.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Eosinophilic oesophagitis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Investigations | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Influenza b virus test positive | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Hip surgery | Surgical and medical procedures | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypoesthesia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
Publications (abstracts, posters or presentations) must be presented to the Publication Steering Committee for review prior to submission or public display and are not allowed prior to the publication of the primary manuscript, or eighteen (18) months from the conclusion of the Study. PI shall provide Sponsor a copy of any proposed public disclosure at least 30 days prior to submission. Sponsor may ask PI to delay the disclosure for a maximum of 60 days to file proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher James, VP Head of Clinical Operations | Mesoblast, Inc. | 212-880-2060 | 7925 | Christopher.James@Mesoblast.com |
| Jun 15, 2022 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D010146 | Pain |
| D013122 | Spinal Diseases |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Superiority |
The superiority threshold was 0.9875. |
The posterior probability of superiority to placebo was 0.6427. |
| OG002 | Placebo | Participants received saline solution as matching-placebo on Day 0 (Visit 2). |
|
|
|
| OG002 | Placebo | Participants received saline solution as matching-placebo on Day 0 (Visit 2). |
|
|
|
| OG002 | Placebo | Participants received saline solution as matching-placebo on Day 0 (Visit 2). |
|
|
|
| OG002 | Placebo | Participants received saline solution as matching-placebo on Day 0 (Visit 2). |
|
|
|
|
|
|
| OG002 | Placebo | Participants received saline solution as matching-placebo on Day 0 (Visit 2). |
|
|
|
Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with HA solution on Day 0 (Visit 2).
| OG002 | Placebo | Participants received saline solution as matching-placebo on Day 0 (Visit 2). |
|
|
|