Mesoblast Chronic Low Back Pain Trial Recruitment 2026: Apply Online for 300 Vacancies
Mesoblast Chronic Low Back Pain Trial Recruitment 2026
- Job Title: Patient Recruitment for Pivotal Phase 3 Clinical Trial.
- Organization: Mesoblast Limited.
- Therapeutic Area: Chronic Low Back Pain (CLBP) associated with Degenerative Disc Disease (DDD).
- Trial Phase: Phase 3 (Pivotal).
- Investigational Product: Rexlemestrocel-L (allogeneic cellular medicine).
- Trial Design: Placebo-controlled, randomized, single intra-discal injection.
- Patient Target: Recruitment of at least 300 patients.
- Primary Endpoint: Significant reduction in low back pain at 12 months.
- Secondary Endpoints: Improvements in function, quality of life, and cessation of pain medication (including opioids).
- Potential Benefits: Development of a non-opioid, disease-modifying therapy for CLBP.
- Regulatory Status: Rexlemestrocel-L has RMAT designation from the FDA.
- Expected Outcomes: Top-line results mid-CY2027, potential FDA filing Q3 CY2027.
Important Dates
Salary & Pay Scale
Documents Required for Application
- Proof of identity (e.g., Driver’s License, Passport).
- Medical records confirming diagnosis of Chronic Low Back Pain (CLBP) and Degenerative Disc Disease (DDD).
- List of current medications, especially pain relievers and opioids.
- Insurance information (if applicable).
- Contact information for primary care physician.
Educational Qualification
- Patients diagnosed with Chronic Low Back Pain (CLBP) associated with Degenerative Disc Disease (DDD).
- Duration of CLBP due to DDD less than five years.
- Must be willing to undergo a single intra-discal injection of rexlemestrocel-L or sham control.
- Must be able to attend follow-up appointments for 12 months.
- Patients on opioids are particularly encouraged to participate.
Vacancy Details – Post Wise
| Category | Vacancy |
|---|---|
| Total Patients to be Recruited | 300 |
Application Fee
| Category | Fee Amount |
|---|---|
| General / OBC / EWS | N/A |
| SC / ST | N/A |
| PH / PWD | N/A |
| Female | N/A |
| Ex-Servicemen | N/A |
| Payment Mode | N/A |
Age Limit
Selection & Exam Process
Clinical Trial Participation
- Initial screening to determine eligibility based on diagnosis and medical history.
- Randomization to either the treatment group (rexlemestrocel-L) or the control group (sham injection).
- Regular follow-up assessments for 12 months to monitor pain levels, function, quality of life, and medication usage.
- Data analysis to determine the efficacy and safety of rexlemestrocel-L.
Clinical Trial Protocol
The trial involves a single intra-discal injection and a 12-month follow-up period. Key assessments include:
- Baseline Assessment: Comprehensive medical evaluation, pain assessment, functional status, and medication review.
- Intervention: Single intra-discal injection of either rexlemestrocel-L or a sham control.
- Follow-up Visits (Monthly/Quarterly):
- Pain intensity assessment (e.g., using Visual Analog Scale – VAS).
- Functional capacity evaluation (e.g., Oswestry Disability Index – ODI).
- Quality of life questionnaires.
- Assessment of pain medication usage (including opioids).
- Adverse event monitoring.
- Primary Endpoint Measurement: Change in low back pain score at 12 months compared to baseline.
- Secondary Endpoint Measurements: Improvements in function, quality of life, and reduction/cessation of pain medication use.
How to Apply – Step by Step
- Interested individuals should consult with their healthcare provider to discuss eligibility for the Mesoblast Phase 3 trial for Chronic Low Back Pain.
- Contact the clinical trial site directly for screening and enrollment procedures. Contact information for participating sites can typically be found through clinical trial registries or by contacting Mesoblast’s clinical trial information line.
- Undergo a thorough screening process to confirm diagnosis and meet all inclusion/exclusion criteria.
- If eligible, provide informed consent to participate in the trial.
- Follow the trial protocol, including attending all scheduled follow-up visits and undergoing study procedures.
Important Links
Frequently Asked Questions
Understanding the Mesoblast Phase 3 Trial for Chronic Low Back Pain
This document outlines the key aspects of Mesoblast’s pivotal Phase 3 clinical trial for chronic low back pain (CLBP), focusing on the investigational therapy rexlemestrocel-L. As this is a clinical trial recruitment, the ‘preparation’ is geared towards understanding the trial’s purpose, eligibility, and what participation entails, rather than traditional job preparation.
Trial Overview and Objectives
Mesoblast Limited is conducting a Phase 3 clinical trial to evaluate the efficacy and safety of rexlemestrocel-L, a novel cellular therapy, for treating chronic low back pain caused by degenerative disc disease (DDD). The trial aims to confirm findings from earlier studies, specifically the potential for a single injection to provide long-term pain relief and reduce reliance on opioid medications. The primary goal is to demonstrate a significant reduction in pain at 12 months compared to a placebo. Secondary objectives include assessing improvements in physical function, quality of life, and the ability of patients to cease pain medication, particularly opioids.
Eligibility Criteria: Who Can Participate?
Participation in this trial is strictly based on specific medical criteria. Potential participants must:
- Be diagnosed with Chronic Low Back Pain (CLBP).
- Have CLBP specifically associated with Degenerative Disc Disease (DDD).
- Have experienced CLBP due to DDD for less than five years.
- Be willing to receive either an injection of rexlemestrocel-L or a sham (placebo) injection.
- Be committed to attending all scheduled follow-up appointments for a period of 12 months.
- Patients who are currently using opioid pain medications are particularly encouraged to consider participating, as a key outcome is to assess the therapy’s potential to reduce opioid dependence.
Exclusion criteria will also apply, and these will be determined during the screening process to ensure patient safety and the integrity of the trial data. This may include other significant medical conditions or previous treatments.
The Treatment and Follow-up Process
If enrolled, participants will undergo a single intra-discal injection. This procedure involves delivering the study drug (rexlemestrocel-L) or the sham control directly into the affected disc in the lower back. Following the injection, participants will enter a 12-month follow-up period. During this time, they will attend regular appointments where their progress will be closely monitored. This monitoring includes:
- Pain Assessment: Using standardized scales to quantify pain levels.
- Functional Assessment: Evaluating the impact of pain on daily activities and physical capabilities.
- Quality of Life Measures: Assessing overall well-being and life satisfaction.
- Medication Review: Tracking the use of pain medications, especially opioids, to determine if reduction or cessation is possible.
- Adverse Event Monitoring: Recording any side effects or complications experienced by the participant.
The data collected during these follow-up visits are crucial for determining the effectiveness and safety profile of rexlemestrocel-L.
Potential Benefits and Significance
For participants, the trial offers a potential opportunity to receive an innovative treatment for chronic low back pain that may offer long-term relief without the risks associated with opioid use. The development of rexlemestrocel-L could represent a significant advancement in pain management, offering a disease-modifying approach rather than just symptom management. Mesoblast’s therapy targets the underlying inflammatory processes contributing to disc degeneration, aiming for a more fundamental solution to CLBP. The RMAT designation from the FDA further underscores the potential of this therapy.
Next Steps for Interested Individuals
Individuals experiencing chronic low back pain due to degenerative disc disease and who meet the preliminary criteria should discuss this trial with their physician. They can then inquire about participating clinical trial sites in the U.S. and initiate the screening process. This trial represents a critical step towards potentially bringing a new, non-opioid treatment option to millions suffering from this debilitating condition.
All information is compiled from official notifications for informational purposes only. Applicants must verify all details from the official notification PDF and official website before applying. We are not responsible for any error or inconvenience caused.