HYDRAFIL for Degenerative Disc Disease

(HYDRAFIL-D Trial)

Recruiting at 8 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

Trial Summary

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.

Is HYDRAFIL safe for humans?

The safety data for HYDRAFIL specifically is not available, but similar products like hyaluronic acid fillers are generally considered safe, with most side effects being mild or moderate and temporary. However, as with any medical procedure, there can be severe adverse events, so it's important to be informed of potential risks. ^{1 2 3 4 5}

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

The HYDRAFIL treatment is unique because it involves a minimally invasive approach using a gel-like substance to restore disc function, which differs from traditional surgical methods like discectomy or spinal fusion. This approach aims to maintain disc height and flexibility, offering a potential alternative to more invasive procedures. ^{6 7 8 9 10}

What is the purpose of this trial?

A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL™ System.

Research Team

Douglas P Beall, MD

Principal Investigator

Clinical Investigations LLC

Kasra Amirdelfan, MD

Principal Investigator

IPM Medical Group

Eligibility Criteria

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

My MRI shows I have moderate to severe disc degeneration.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2021]

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

Transvascular Hydrolysis of Hyaluronic Acid Filler With Hyaluronidase: An Ex Vivo Study. [2021]

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

Learning curves: historical trends of FDA-reported adverse events for dermal fillers. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Consensus statement on prevention and management of adverse effects following rejuvenation procedures with hyaluronic acid-based fillers. [2022]

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

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

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

Biologic therapies to enhance intervertebral disc repair. [2018]

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

Regenerative Medicine Modalities for the Treatment of Degenerative Disk Disease. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

The PDN prosthetic disc-nucleus device. [2013]

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

Lumbar disc rehydration postimplantation of a posterior dynamic stabilization system. [2016]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of DiscoGel in Treatment of Degenerative Disc Disease: A Prospective 1-Year Observation of 67 Patients. [2023]