HYDRAFIL for Back Pain Due to Degenerative Disc Disease

Overseen By Robert Townsend, Sr. Director Clinical Affairs

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ReGelTec, Inc.

Disqualifiers: Infections, Disc herniation, Spinal stenosis, Previous back surgery, Diabetes, others

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

Compensation: Varies

Number of Visits: 3

Duration: Immediate post-treatment

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a treatment called HYDRAFIL for individuals experiencing back pain due to degenerative disc disease, a condition where spinal discs wear down and cause pain. The study involves implanting a polymer into one or two lumbar discs. It seeks participants who have experienced low back pain for at least six months and have not found relief with pain medication or physical therapy. This trial may suit those diagnosed with lumbar disc degeneration visible on an MRI scan. As an unphased trial, it offers a unique opportunity for patients to contribute to pioneering research that could lead to new treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the HYDRAFIL implant is safe for treating degenerative disc disease?

Research has shown that HYDRAFIL, a type of gel implant, has been tested for safety in treating back pain caused by worn-out discs. An early study found the implant safe, with no long-lasting serious side effects, and it significantly reduced pain. Another report noted that HYDRAFIL improved average pain scores from 7.1 to 2.0 six months after treatment. Additionally, HYDRAFIL has received CE Mark approval in Europe, indicating it meets certain safety standards for treating this condition. Overall, these findings suggest that HYDRAFIL is generally safe and well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HYDRAFIL for back pain due to degenerative disc disease because it offers a unique approach compared to standard treatments like physical therapy, medications, and surgery. Unlike these options, HYDRAFIL involves implanting a polymer directly into one or two lumbar discs, potentially providing targeted relief and structural support. This innovative delivery method could help preserve disc function and reduce pain, offering a promising alternative for those seeking more effective relief from chronic back pain.

What evidence suggests that the HYDRAFIL implant is effective for back pain due to degenerative disc disease?

Research has shown that HYDRAFIL, the treatment under study in this trial, may help treat back pain caused by degenerative disc disease. In one study, patients' pain levels dropped significantly, from an average score of 7.1 to 2.0, six months after treatment. Another study reported a substantial decrease in back pain, with average pain scores falling from 7 to 1. HYDRAFIL has also been associated with improved movement and relief from long-term low back pain. These results suggest that HYDRAFIL could be an effective option for relieving back pain. ^{2 3 4 5 6}

Who Is on the Research Team?

Olivier Clerk-Lamalice, MD, MSc, FRCPC, FIPP

Principal Investigator

Beam Interventional & Diagnostic Imaging

Are You a Good Fit for This Trial?

Inclusion Criteria

You are 22 to 80 years old.

You have disc degeneration on MRI with at least one level of disc height loss.

Signed an informed subject consent form in a language in which they are fluent.

Exclusion Criteria

You have severe compression on your cauda equina, which is the bundle of nerves at the lower end of your spinal cord.

You have had or currently have an infection in your whole body or in a specific area.

Annular tear or defect that shows free contrast extravasation into the epidural space during or after discography

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Polymer Implant of HYDRAFIL into one or two lumbar intervertebral discs

Immediate post-treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular visits at 3, 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• HYDRAFIL

How Is the Trial Designed?

Group I: HYDRAFIL Implant Experimental Treatment 1 Intervention

Polymer Implant of HYDRAFIL into a one or two lumbar intervertebral discs

Who Is Running the Clinical Trial?

ReGelTec, Inc.

Lead Sponsor

Trials

2

Recruited

260+

Published Research Related to This Trial

In a study of 29 patients with degenerative disc disease who did not respond to conservative treatments, percutaneous intradiscal GelStix administration significantly reduced pain levels, with mean visual analogue scale (VAS) scores dropping from 7.14 to 2.48 over 12 months (P < 0.001).

Patients also experienced improved functionality, as indicated by a decrease in the Oswestry Disability Index (ODI) scores from 28.14 to 17.35, and 86.2% reported satisfaction with the procedure at the 12-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical results of intradiscal hydrogel administration (GelStix) in lumbar degenerative disc disease Ceylan, A., Aşik, I., Özgencil, GE., et al.[2020]

In a study involving 20 patients with chronic low back pain due to degenerative disc disease, the use of intradiscal hydrogel showed significant effectiveness, reducing pain scores from a median of 7 to 1 and improving disability scores significantly over a follow-up period of 6 months.

The treatment was deemed safe, with only 5 serious adverse events reported, 4 of which were associated with the treatment, but no persistently symptomatic adverse effects were noted, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hydrogel Augmentation of the Lumbar Intervertebral Disc: An Early Feasibility Study of a Treatment for Discogenic Low Back Pain. Beall, DP., Amirdelfan, K., Nunley, PD., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06011551

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) ...

2. embs.org embs.org/pulse/articles/noninvasive-injectables-for-chronic-low-back-pain/

Noninvasive Injectables for Chronic Low Back Pain They reported that HYDRAFIL improved average pain-scale scores from 7.1 to 2.0 at 6 months posttreatment [2]. Since then, they have treated ...

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

An Early Feasibility Study of a Treatment for Discogenic ... Preliminary results showed significant reductions in median NRS back pain from 7 (range 4–10) to 1 (range 0–8) (P <.0001) and median ODI scores from 54 (range ...

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

Delayed percutaneous intradiscal hydrogel herniation causing ... An unpublished report by ReGelTec Inc. claimed that Hydrafil hydrogel was effective in reducing the NRS score for back pain from 7.2 ( ...

5. medicaleconomics.com medicaleconomics.com/view/regeltec-s-hydrafil-system-receives-ce-mark-for-treating-chronic-low-back-pain

ReGelTec's HYDRAFIL System receives CE Mark for ... ReGelTec's HYDRAFIL System offers a minimally invasive treatment for chronic low back pain, promising significant pain relief and improved function.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04984629

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 ...