ReGelTec – Phase III Clinical Trial

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ReGelTec – Phase III Clinical Study to Evaluate the Safety and Effectiveness of the ReGelTec HYDRAFIL System in Subjects with Axial Chronic Low Back Pain (CLBP) due to Degenerative Disc Disease (DDD)

Source Healthcare is proud to announce its involvement in a pivotal Phase III clinical trial for ReGelTec’s investigational therapy, HYDRAFIL. This innovative treatment aims to provide lasting relief for patients suffering from chronic low back pain caused by degenerative disc disease, a condition that affects millions and limits daily functioning.

Overview of the Discgenics IDCT Clinical Trial

The ReGelTec Phase III clinical trial is a groundbreaking study that aims to evaluate the safety and effectiveness of an innovative regenerative therapy for chronic low back pain caused by degenerative disc disease. The HYDRAFIL System may be used to deliver a percutaneous spinal implant (the HYDRAFIL implant) at up to two lumbar disc levels, and is designed to supplement the degenerated nucleus material without requiring the destruction or removal of any the subject’s remaining disc tissue.This groundbreaking treatment aims to achieve a minimal clinically important difference in back pain scores in comparison to conservative care management.

Participants in the trial will undergo a structured program, including an initial screening phase, a single treatment injection, and follow-up visits over 24 months. The study is a step in offering a minimally invasive alternative for patients who have not found relief through conventional therapies, providing hope for long-term pain management and improved quality of life.

Study Design and Visit Requirements

The ReGelTec – Phase III clinical trial is a structured program that aims to assess the efficacy and safety of HYDRAFIL. Participants will engage in the study over 24 months, with a minimum of 7 visits to the research site. These visits are divided into three distinct phases: screening, treatment, and follow-up. Here’s what you can expect during each phase.

Screening Phase

Before beginning the trial, you will undergo a thorough screening to determine your eligibility. This includes a medical history review, diagnostic tests, imaging (MRI and XRay) and discussions with our clinical team about your health and pain history. The goal is to confirm that you meet all the criteria for participation, ensuring the trial is suitable for your condition and will deliver meaningful results.

Treatment Phase

Once enrolled, you will receive a percutaneous injection of HYDRAFIL (the investigational treatment) or continue conservative management (sham) as part of the study’s control group. This single outpatient procedure is minimally invasive and administered directly into the affected spinal disc. The treatment targets inflammation and supports tissue repair to relieve pain.

Follow-Up Phase

After treatment, you will participate in regular follow-up visits over 24 months. These visits allow our team to monitor your progress, assess your response to the treatment, and ensure your overall health. You’ll undergo physical exams, pain assessments, and functional evaluations. This phase is critical for understanding the long-term benefits of the drug.

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Potential Benefits of Participation:

  • Access to a state-of-the-art therapy that could alleviate chronic back pain.
  • All treatments, assessments, and diagnostics are covered at no cost to you or your insurance.
  • Participants will receive compensation for their time and travel associated with the study.

Cost and Compensation for Participation

Participating in the ReGelTec clinical trial comes at no cost to you. All treatments, diagnostic procedures, and assessments required for the study are fully covered by the trial sponsor. Additionally, you will receive compensation for your time and travel to each of the follow up visits over the 24-month study period. This ensures you can focus on your health and participation without financial burden.

You May Be Eligible to Participate in the Study if:

  • You are 22-85 years of age
  • You have experienced chronic low back pain for at least six months
  • You have been diagnosed with degenerative disc disease
  • You have not found relief from conservative treatments over the past six months
  • You are not pregnant or planning to become pregnant during the 24-month study period
  • You have not undergone prior lumbar spine surgery

How to Enroll in the ReGelTec – Phase III Clinical Trial

If you are interested in participating or would like more information about the ReGelTec Clinical Trial, we invite you to contact our research team.

Phone: Call (310) 574-2777

Email: research@sourcehealthcare.com

(310) 574-2777

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