HYDRAFIL for Back Pain Due to Degenerative Disc Disease

Recruiting at -1 trial locations

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

35 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new gel injection treatment for people with severe back pain from worn-out spinal discs. It aims to help those who haven't gotten better with other treatments by cushioning the damaged areas in their spine.

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 data supports the effectiveness of the treatment HYDRAFIL for back pain due to degenerative disc disease?

Research on intradiscal hydrogel treatments, like GelStix, shows they can help reduce back pain in patients with degenerative disc disease who haven't responded to other treatments. This suggests that HYDRAFIL, a similar hydrogel treatment, might also be effective for back pain caused by this condition. ^{1 2 3 4 5}

How is the treatment HYDRAFIL different from other treatments for degenerative disc disease?

HYDRAFIL is unique because it involves the injection of a hydrogel into the intervertebral disc, which acts as a reservoir of hydration to increase pressure and improve pH balance, potentially preserving the disc. This approach is different from traditional treatments like surgery or conservative management, as it aims to regenerate and maintain the disc's health. ^{1 3 6 7 8}

Research Team

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

Principal Investigator

Beam Interventional & Diagnostic Imaging

Eligibility Criteria

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

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

Treatment Details

Interventions

• HYDRAFIL

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Hydrogel Augmentation of the Lumbar Intervertebral Disc: An Early Feasibility Study of a Treatment for Discogenic Low Back Pain. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Influence of age on pain intensity, functional impairment and health-related quality of life before and after surgery for lumbar degenerative disc disease. [2022]

3. Turkey pubmed.ncbi.nlm.nih.gov

Clinical results of intradiscal hydrogel administration (GelStix) in lumbar degenerative disc disease [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Are Primary Outcomes Really Primary? An Exploratory Cross-Sectional Nationwide Web-Based Survey Study for Outcomes Reflecting Real Symptoms and Needs of Patients with Lumbar Disc Herniation. [2023]

5. India pubmed.ncbi.nlm.nih.gov

The effectiveness of exercise program after lumbar discectomy surgery. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy of the Gelstix nucleus augmentation device for the treatment of chronic discogenic low back pain: protocol for a randomised, sham-controlled, double-blind, multicentre trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Cellular transplantation and platelet-rich plasma injections for discogenic pain: a contemporary review. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Advances in surgical management of lumbar degenerative disease. [2022]