LDGraft for Degenerative Disc Disease

(RESTORE Trial)

Recruiting at 2 trial locations

Overseen By Robyn Cochrane

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Locate Bio Pty Ltd

Must not be taking: Chronic steroids, Radiation therapy

Disqualifiers: Previous lumbar surgery, Active malignancy, Smoking, Osteoporosis, others

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

Compensation: Varies

Number of Visits: 8

Duration: Immediate post-operative period

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called LDGraft for individuals with lumbar degenerative disc disease (DDD), a condition affecting the spine that can cause back pain and mobility issues. The trial aims to assess the safety and effectiveness of LDGraft compared to a standard bone graft during a specific spinal surgery. Participants will receive either LDGraft or the standard treatment. Those who have struggled with lumbar DDD at one spinal level, have not found relief with other treatments for six months, and are scheduled for a certain type of spine surgery might be suitable for this trial. As a Phase 1, Phase 2 trial, the research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications that interfere with bone or soft tissue healing, you may not be eligible to participate.

What prior data suggests that the LDGraft device is safe for treating lumbar degenerative disc disease?

Research is examining the safety and effectiveness of LDGraft for treating lumbar degenerative disc disease (DDD). Earlier studies found that various doses of LDGraft were as safe as using bone grafts from the hip bone, a common method. This suggests that LDGraft is generally well-tolerated by patients.

The current study is in the early stages of human testing, focusing on the treatment's safety. At this point, safety remains the main concern, and researchers closely monitor any possible side effects. Although specific results from this study are not yet available, the early phase involves careful evaluation of the treatment's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

LDGraft is unique because it offers a new approach to treating degenerative disc disease by using a specialized allograft bone. Unlike traditional treatments that often focus on pain relief through medications or surgical interventions, LDGraft aims to support the regeneration of disc tissue. Researchers are excited because it incorporates a bioactive component, potentially enhancing the body's natural healing process. This could lead to improved long-term outcomes and reduced reliance on invasive procedures.

What evidence suggests that the LDGraft device is effective for degenerative disc disease?

Research has shown that LDGraft may help treat lumbar degenerative disc disease (DDD). This trial will test different doses of LDGraft, specifically 0.5mg/cc and 1.0mg/cc, as separate treatment arms. Studies have found that these doses of LDGraft work as well as the commonly used iliac crest bone grafts in these procedures. This suggests LDGraft could help reduce back pain and improve movement for people with DDD. Major conferences have discussed the treatment, highlighting its potential benefits. Early results suggest LDGraft could be a safe and effective choice for patients undergoing spine surgery. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 22-80 with lumbar degenerative disc disease who haven't improved after 6 months of non-surgical treatments. Candidates must have specific spinal conditions like facet joint degeneration and decreased disc height, among others, and a disability score indicating moderate to severe disability.

Inclusion Criteria

I am between 22 and 80 years old and considered fully grown.

I am willing to follow the study and post-treatment plans.

My joint moves more than it should or is overly bent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a single level Anterior Lumbar Interbody Fusion (ALIF) procedure with either LDGraft or allograft

Immediate post-operative period

1 visit (in-person for surgery)

Post-operative Recovery

Participants recover from surgery and begin initial post-operative assessments

6 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including assessments of disability index and pain scores

24 months

Multiple visits (in-person and virtual) at 6 weeks, 3 months, 6 months, 12 months, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• LDGraft

Trial Overview

The study compares the safety and effectiveness of LDGraft (a new device) versus traditional allograft bone in anterior lumbar interbody fusion surgery for patients with lumbar spine issues due to degenerative disc disease.

How Is the Trial Designed?

Group I: LDGraft 1.0mg/cc Experimental Treatment 1 Intervention

Group II: LDGraft 0.5mg/cc Experimental Treatment 1 Intervention

Group III: Control Allograft Bone Active Control 1 Intervention

Who Is Running the Clinical Trial?

Locate Bio Pty Ltd

Lead Sponsor

Trials

1

Recruited

40+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06462729

LDGraft in Single Level Anterior Lumbar Interbody Fusion ...

The objective of this study is to evaluate the safety and effectiveness of LDGraft (investigational device) compared to 100% human tissue product allograft ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11568700/

Comparative study of clinical effects between oblique lumbar ...

Conclusion: LLIF and OLIF may be both safe and effective minimally invasive surgical methods for the treatment of degenerative disc disease of the lumbar spine.

3.

becarispublishing.com

becarispublishing.com/doi/10.2217/cer-2017-0047

Comparison of therapies in lumbar degenerative disc ...

A network meta-analysis was conducted to determine the relative impact of lumbar DDD therapies on Oswestry Disability Index (ODI) success, back pain score, ...

4.

journals.lww.com

journals.lww.com/spinejournal/fulltext/2022/03010/comparison_of_mid__to_long_term_follow_up_of.1.aspx

Comparison of Mid- to Long-term Follow-up of... : Spine

The aim of this article is to compare the mid- to long-term patient-reported outcome measures (PROMs) between single-level total disc arthroplasty (TDA), multi ...

5.

locatebio.com

locatebio.com/us/product/ldgraft/

LDGraft

Our results have been presented at both Spine Week (2023) and NASS (2023). We reported all three rhBMP-2 doses tested were equivalent to iliac crest bone graft ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2989192/

A meta-analysis of artificial total disc replacement versus ...

The 2-year results suggest that TDR has similar effectiveness and safety comparable to lumbar fusion for the treatment of lumbar DDD. However, the 2-year follow ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666548424002725?dgcid=rss_sd_all

A systematic review of bone graft products used in lumbar ...

Systematic Reviews /Meta-analyses. A systematic review of bone graft products used in lumbar interbody fusion procedures for degenerative disc disease.