HYDRAFIL for Degenerative Disc Disease

(HYDRAFIL-D Trial)

Recruiting at 10 trial locations

Overseen By Pierce Nunley, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ReGelTec, Inc.

Must not be taking: Opioids, Anticoagulants

Disqualifiers: Infection, Disc herniation, Prior surgery, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

225 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of a new treatment for people with degenerative disc disease (DDD), which causes ongoing lower back pain. The treatment, the ReGelTec HYDRAFIL™ System, involves inserting a hydrogel implant into the spine to potentially manage pain. Participants will either receive the implant along with their usual care or continue their usual care with a mock procedure for comparison. Individuals who have experienced lower back pain for more than six months and have tried other treatments without success might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for managing chronic lower back pain.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have had an epidural steroid injection, intradiscal injection, or certain other injections within 60 days before joining. Also, if you are on opioids, you must not exceed 60 MME (morphine milligram equivalent) per day or have increased your dose in the last 60 days.

What prior data suggests that the ReGelTec HYDRAFIL™ System is safe for treating degenerative disc disease?

Research has shown that the ReGelTec HYDRAFIL System has been safe in earlier studies. In one study, patients who received the hydrogel implant did not experience any lasting serious side effects, indicating that the treatment is generally well-tolerated. Additionally, an unpublished report found that the system helped reduce back pain without causing harm. Although the treatment is still under study, these findings are promising for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for degenerative disc disease focus on pain management through physical therapy, medications, or surgery. But the HYDRAFIL System introduces a novel approach with its percutaneous hydrogel spinal implant. This treatment stands out because it involves a minimally invasive procedure to deliver a hydrogel directly to the spine, potentially providing structural support and pain relief without the need for major surgery. Researchers are excited about HYDRAFIL because it could offer a quicker recovery time and reduce the risks associated with traditional surgeries, making it a promising option for patients seeking less invasive solutions.

What evidence suggests that the ReGelTec HYDRAFIL™ System is effective for degenerative disc disease?

This trial will compare the ReGelTec HYDRAFIL System with a control procedure. Research has shown that the ReGelTec HYDRAFIL System could help treat degenerative disc disease. Early studies found that the hydrogel implant effectively reduces chronic low back pain. Patients reported significant pain relief without serious side effects. The treatment uses a simple procedure to cushion the spine, potentially lessening discomfort. While more information is needed, the initial results are promising for people with this condition. ^{1 2 4 5 6}

Who Is on the Research Team?

Douglas P Beall, MD

Principal Investigator

Clinical Investigations LLC

Kasra Amirdelfan, MD

Principal Investigator

IPM Medical Group

Are You a Good Fit for This Trial?

This trial is for men and women aged 22-85 with lower back pain due to degenerative disc disease, confirmed by MRI and discography. Participants must have tried conservative care for six months without relief, be able to follow the study's procedures, complete forms, and speak English fluently.

Inclusion Criteria

You are capable of completing the requirements and participating in this protocol, both mentally and physically.

My MRI shows I have moderate to severe disc degeneration.

My symptoms didn't improve after 6 months of standard treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the HYDRAFIL implant or a sham procedure as part of the study

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• ReGelTec HYDRAFIL™ System

Trial Overview

The HYDRAFIL-D trial is testing the ReGelTec HYDRAFIL™ System against standard conservative care management in patients with degenerative disc disease. It's a multi-center study where participants are randomly assigned to one of these two approaches.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 2 Interventions

Group A: continued non-surgical conservative medical management plus a percutaneous hydrogel spinal implant delivered via the HYDRAFIL System (the HYDRAFIL implant) (the "Treatment Arm")

Group II: Control Arm Placebo Group 1 Intervention

Group B: continued non-surgical conservative medical management plus advancement of the HYDRAFIL System delivery needle to inside the skin in the direction of the target disc(s) but without contacting the muscle layer or deeper (the "Control Arm")

Who Is Running the Clinical Trial?

ReGelTec, Inc.

Lead Sponsor

Trials

2

Recruited

260+

Published Research Related to This Trial

The PDN device, designed to mimic the cushioning function of a healthy intervertebral disc, offers a new treatment option for moderate degenerative disc disease, addressing limitations of traditional methods like discectomy and immobilization.

Implantation of the PDN device can be performed using two surgical approaches, allowing for flexibility in treatment, and it aims to restore disc height and maintain normal motion, which is crucial for disc health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The PDN prosthetic disc-nucleus device. Ray, CD.[2013]

In a study of 67 patients with chronic lumbar discogenic pain (DP) and radicular leg pain (RLP), minimally invasive DiscoGel therapy significantly reduced pain and disability scores after one year, with a 66% reduction in COMI and 53% in VAS for DP patients, and a 48% reduction in COMI and 54% in VAS for RLP patients.

The therapy was well-tolerated with no adverse effects reported, and a high percentage of patients (74% for DP and 81% for RLP) were able to stop using analgesics six months post-treatment, indicating its efficacy as a non-surgical option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of DiscoGel in Treatment of Degenerative Disc Disease: A Prospective 1-Year Observation of 67 Patients. Latka, K., Kozlowska, K., Waligora, M., et al.[2023]

In a study of 4500 patients receiving 9324 treatments with the hyaluronic acid filler Juvéderm Voluma, delayed adverse events (DAEs) occurred at a rate of 0.98% per patient, primarily manifesting as delayed swelling and nodule formation.

DAEs were generally transient and resolved without complications, with a potential link to immunologic triggers and an increase in frequency during certain months, suggesting that the degradation process of the filler may play a role in these reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective review of delayed adverse events secondary to treatment with a smooth, cohesive 20-mg/mL hyaluronic acid filler in 4500 patients. Humphrey, S., Jones, DH., Carruthers, JD., et al.[2021]

The study analyzed historical adverse event (AE) data for FDA-approved dermal fillers to identify learning curves associated with new fillers, helping to differentiate between expected learning-related AEs and those due to the product's characteristics.

Understanding these learning curves can improve safety monitoring and response strategies for new fillers, ensuring that reactions to AEs are based on comprehensive data analysis rather than assumptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning curves: historical trends of FDA-reported adverse events for dermal fillers. Chandawarkar, AA., Provenzano, DJ., Rad, AN., et al.[2019]

A young male patient with disc degeneration showed significant improvement after treatment with the BioFlex dynamic stabilization device, indicating a potential mechanical approach to disc regeneration.

One year post-surgery, MRI results revealed an increase in disc height and rehydration, suggesting that restoring the physiological status of the spinal segment is crucial for effective disc regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumbar disc rehydration postimplantation of a posterior dynamic stabilization system. Cho, BY., Murovic, J., Park, KW., et al.[2016]

Regenerative medicine aims to transform the harmful environment of degenerative disk disease into a healing one, using treatments like mesenchymal stem cells and gene therapy, which have shown promise in both lab and animal studies.

Despite the potential of these innovative treatments, clinical applications are currently limited due to insufficient high-quality data, highlighting the need for further research to optimize these regenerative strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regenerative Medicine Modalities for the Treatment of Degenerative Disk Disease. McDonnell, JM., Ahern, DP., Ross, TD., et al.[2022]

Degenerative disc disease leads to chronic pain and structural failure of intervertebral discs due to a cycle of inflammation and tissue degradation.

Platelet-rich plasma (PRP) therapy is emerging as a safe and effective minimally invasive treatment for degenerative disc disease, showing promise in improving outcomes for chronic back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biologic therapies to enhance intervertebral disc repair. Anitua, E., Padilla, S.[2018]

Hyaluronidase (HYAL) effectively degrades crosslinked hyaluronic acid (HA) fillers in human blood vessels, with minimal remaining HA after treatment, indicating its potential to relieve vascular obstruction caused by filler injections.

However, a single dose of HYAL may not be sufficient to fully restore blood flow in cases of embolism, suggesting that higher and more frequent doses may be necessary for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transvascular Hydrolysis of Hyaluronic Acid Filler With Hyaluronidase: An Ex Vivo Study. Rauso, R., Zerbinati, N., Fragola, R., et al.[2021]

Hyaluronic acid fillers are effective for correcting facial aging, providing quick, outpatient treatments with minimal downtime and predictable, long-lasting results.

While most adverse reactions to these fillers are mild and temporary, severe events can occur, highlighting the importance of thorough patient education on risks and the need for clinicians to be well-informed to manage potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consensus statement on prevention and management of adverse effects following rejuvenation procedures with hyaluronic acid-based fillers. Philipp-Dormston, WG., Bergfeld, D., Sommer, BM., et al.[2022]

Hyaluronic acid and calcium hydroxylapatite fillers are generally safe and effective, but complications like nodules can occur, often due to injection technique or contamination rather than the fillers themselves.

A problem-oriented approach to diagnosing and managing filler nodules, including the use of ultrasonographic imaging for persistent cases, can improve treatment outcomes and help prevent complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A problem-oriented approach to nodular complications from hyaluronic acid and calcium hydroxylapatite fillers: classification and recommendations for treatment. Cassuto, D., Sundaram, H.[2021]

Citations

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clinicaltrials.gov

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NCT04984629 | Study of the ReGelTec HYDRAFIL System

This study is designed to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL System in subjects with axial low back pain (LBP) due to degenerative ...

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Study Details | NCT06011551 | HYDRAFIL-D: HYDRogel ...

This pivotal study is designed to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL System in subjects with axial chronic low back pain (CLBP) ...

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The FDA Approves IDE for ReGelTec's Pivotal Study of ...

Once approved, the HYDRAFIL™ System will offer patients suffering from chronic back pain due to degenerative disc disease a minimally invasive ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11616144/

Delayed percutaneous intradiscal hydrogel herniation causing ...

The authors present a rare case of a patient with herniated intradiscal hydrogel following a minor trauma leading to neurological injury.

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1051044323006942

An Early Feasibility Study of a Treatment for Discogenic ...

This early feasibility study showed that the hydrogel implant was safe with no persistently symptomatic SAEs, and demonstrated effectiveness with significant ...

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orthospinenews.com

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ReGelTec Announces First Patient Treated in U.S. IDE ...

The HYDRAFIL-D study is a 225-patient, multicenter, single-blinded, randomized, controlled trial evaluating the safety and effectiveness of the HYDRAFIL System ...