P-15L Bone Graft for Degenerative Disc Disease

Not currently recruiting at 34 trial locations

Overseen By Paul Arnold, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CeraPedics, Inc

Disqualifiers: Osteoporosis, Osteopenia, Osteomalacia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new bone graft, P-15L, performs as well as standard bone grafts in aiding recovery for people with degenerative disc disease after spinal surgery. The study compares P-15L to the standard bone used in surgery to assess safety and effectiveness. It also examines how individuals who smoke, are obese, or have diabetes respond to the treatment, as these factors can influence healing. This trial may suit adults with persistent back and leg pain who require surgery on the discs between their lower back and pelvis. As an unphased trial, it offers participants the chance to contribute to medical research and potentially benefit from a new treatment option.

Will I have to stop taking my current medications?

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 P-15L Bone Graft is safe for use in degenerative disc disease?

Research shows that the P-15L Bone Graft is generally safe for people. One study tested the P-15L Bone Graft and confirmed its safety. The FDA has approved a similar product, PearlMatrix™ P-15 Peptide Enhanced Bone Graft, for promoting bone growth in the spine. This approval suggests that treatments using P-15L are usually well-tolerated by patients.

While this trial lacks specific data, the approval and past studies indicate that the P-15L Bone Graft typically does not cause serious side effects. However, as with any medical treatment, individual experiences may vary. Potential participants should discuss any concerns with their healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for degenerative disc disease involve fusing the affected vertebrae using bone grafts from the patient's own body, known as autologous bone grafts. But the P-15L Bone Graft offers a new approach. This treatment uses a synthetic peptide-enhanced bone graft that mimics the natural bone growth process more efficiently, potentially leading to quicker recovery and stronger spinal fusion. Researchers are excited because P-15L could reduce the need for harvesting bone from other parts of the patient’s body, minimizing additional surgery and associated pain. Additionally, its unique formulation aims to enhance the body's natural healing, which could improve outcomes for patients.

What evidence suggests that the P-15L Bone Graft is effective for degenerative disc disease?

This trial will compare the P-15L Bone Graft with local autologous bone for treating degenerative disc disease (DDD). Research has shown that the P-15L Bone Graft is designed to be as effective and safe as traditional bone grafts used in spine surgeries. Previous studies found that similar bone grafts with added peptides, like i-FACTOR putty, work well for other spine conditions. These grafts promote new bone growth, aiding in bone healing. While specific data on P-15L's effectiveness for DDD is still being gathered, early results are promising and suggest it could be a reliable option. Ongoing research will provide more clarity on its effectiveness, especially for patients with risk factors like smoking or diabetes. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

Adults aged 22-80 with degenerative disc disease causing back and leg pain, who have not had previous spinal fusion at the affected level (between L2 and S1) can join. They must score ≥35 on a specific back pain questionnaire. Those with significant metabolic diseases affecting bone growth, active cancer, or needing multiple-level fusions are excluded.

Inclusion Criteria

Oswestry Low Back Pain Disability Questionnaire score of ≥ 35

I am between 22 and 80 years old.

I have back pain that spreads to my legs, confirmed by a doctor.

Exclusion Criteria

I have had surgery on my spine before.

My doctor thinks I have a bone condition that could affect bone growth.

I currently have cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo transforaminal lumbar interbody fusion (TLIF) with either P-15L Bone Graft or local autologous bone

Surgical procedure

Follow-up

Participants are monitored for safety and effectiveness, including assessment of Oswestry Disability Index, neurological status, and fusion achievement

24 months

What Are the Treatments Tested in This Trial?

Interventions

• P-15L Bone Graft

Trial Overview The trial is testing if P-15L Bone Graft is as effective and safe as local autologous bone for use in spinal fusion surgery (TLIF) with instrumentation in patients with degenerative disc disease. It will also look closely at results in high-risk groups like smokers, obese individuals, and diabetics.

How Is the Trial Designed?

Group I: P-15L Bone Graft Experimental Treatment 1 Intervention

The investigational group will be treated with P-15L Bone Graft in an instrumented TLIF

Group II: Local autologous bone Active Control 1 Intervention

The active control group will be treated with local autologous bone in an instrumented TLIF

Who Is Running the Clinical Trial?

CeraPedics, Inc

Lead Sponsor

Trials

6

Recruited

1,400+

Published Research Related to This Trial

From 2000 to 2009, surgical treatments for lumbar degenerative disc disease (DDD) in the U.S. increased significantly, with a 2.4-fold rise in procedures performed, indicating a growing reliance on surgical options for this condition.

Among the types of surgeries, anterior and posterior lumbar fusion procedures saw the most substantial increases, while total disc replacement (TDR) remained relatively stable, suggesting that traditional fusion methods are preferred over TDR in the current treatment landscape.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National trends in the surgical treatment for lumbar degenerative disc disease: United States, 2000 to 2009. Yoshihara, H., Yoneoka, D.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03438747

Study Details | NCT03438747 | P-15L Bone Graft in ... The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/P240001B.pdf

summary of safety and effectiveness data (ssed) The objective of the study was to evaluate whether PearlMatrix™ Bone Graft was non-inferior to local autologous bone optionally mixed with ...

3. cerapedics.com cerapedics.com/news/cerapedics-completes-enrollment-pivotal-us-fda-ide-study-its-p-15l-bone-graft

Cerapedics Completes Enrollment of Pivotal U.S. FDA IDE ... The ASPIRE study is intended to evaluate the use of P-15L Bone Graft in transforaminal lumbar interbody fusion surgery in 290 patients with degenerative disc ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03502057/p-15l-bone-graft-lumbar-fusion-clinical-trial

P-15L Bone Graft Lumbar Fusion Clinical Trial Cerapedics currently markets a peptide-enhanced bone graft product, i-FACTOR putty, for use in cervical spine degenerative disk disease. i-FACTOR putty is a ...

5. clinicaltrials.icts.uci.edu clinicaltrials.icts.uci.edu/trial/NCT03438747

P-15L Bone Graft in Transforaminal Lumbar Interbody ... The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and ...

6. cerapedics.com cerapedics.com/news/cerapedics-announces-fda-approval-pearlmatrixtm-p-15-peptide-enhanced-bone-graft-first-and

Cerapedics Announces FDA Approval of PearlMatrix™ P ... PearlMatrix P-15 Peptide Enhanced Bone Graft is the first and only bone growth accelerator proven to accelerate lumbar fusion.