AlloWrap for Post-ACDF Inflammation

Overseen By Elizabeth Esterl, DNP, MS, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AlloSource

Must not be taking: NSAIDs, Steroids

Disqualifiers: Osteoporosis, Active malignancy, Autoimmune, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if AlloWrap, an amniotic membrane, can reduce swelling after anterior cervical discectomy and fusion (ACDF), a neck surgery often required for cervical stenosis or cervical disc problems. Participants will be divided into two groups: one receiving usual care without AlloWrap and the other using AlloWrap during surgery. The study seeks participants with long-term cervical disc disorders or stenosis, scheduled for this surgery, who have not found relief through treatments like physical therapy or medications. As an unphased trial, it offers a unique opportunity to explore a new potential solution for post-surgical swelling.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have taken NSAIDs (non-steroidal anti-inflammatory drugs) within 7 days before surgery.

What prior data suggests that AlloWrap Amniotic Membrane is safe for reducing inflammation in ACDF procedures?

Research shows that AlloWrap Amniotic Membrane is generally well-tolerated. Studies have found that using AlloWrap during surgery can reduce scarring, potentially leading to less pain and a quicker return to normal activities for patients.

Products like AlloWrap have been used in spine surgeries to help reduce scar tissue and improve the success of spinal fusion, suggesting that the treatment is safe and has fewer complications.

While specific side effects of AlloWrap are not detailed, similar products used in surgeries are usually safe for patients. For any concerns, discussing them with a doctor is advisable. ^{1 2 3 4 5}

Why are researchers excited about this study treatment?

Unlike the standard of care for post-ACDF inflammation, which typically involves medications like NSAIDs and corticosteroids to manage pain and swelling, AlloWrap uses an amniotic membrane applied during surgery. This treatment is unique because the amniotic membrane has natural anti-inflammatory and healing properties that could potentially reduce inflammation and promote tissue healing more effectively. Researchers are excited about AlloWrap because it represents a novel approach by leveraging biological materials to enhance recovery, potentially leading to faster and more efficient healing after surgery.

What evidence suggests that AlloWrap is effective for reducing post-ACDF inflammation?

Research has shown that AlloWrap Amniotic Membrane, which participants in this trial may receive, can help reduce swelling after surgery. Studies have found that it acts as a protective layer, potentially leading to less scarring and faster recovery. This may result in less pain and a quicker return to normal activities. Additionally, products like AlloWrap, made from amniotic tissue, have shown promise in reducing scar tissue and improving outcomes in spinal surgeries. These findings suggest that AlloWrap could effectively manage post-surgical swelling and enhance overall recovery. ^{1 2 3 4 6}

Who Is on the Research Team?

Jill Bagdasarian

Principal Investigator

AlloSource

Elizabeth Esterl, DNP, MS, RN

Principal Investigator

AlloSource

Are You a Good Fit for This Trial?

This trial is for adults over 18 with cervical spine issues like stenosis or disc disorders, who haven't found relief through non-surgical treatments. They must understand the study and be scheduled for a specific spinal fusion surgery. Exclusions include those with certain bone diseases, recent steroid injections or NSAIDs use, major health risks, recent substance abuse treatment, other clinical trials participation within 90 days, infections including HIV/Hepatitis B/C, mental impairment affecting study compliance, immune system issues requiring treatment like chemotherapy or radiation therapy.

Inclusion Criteria

Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol

I have been diagnosed with a neck condition or nerve compression confirmed by an MRI or CT scan.

I haven't found relief from non-surgical treatments for over 6 weeks, or I have worsening muscle weakness or unbearable pain.

Exclusion Criteria

I have had surgery on my neck before.

I need surgery to join two or more of my neck bones due to symptoms.

I have inflammation in the neck bones.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo two-level anterior cervical discectomy and fusion (ACDF) procedures with or without the use of AlloWrap®

1 day

1 visit (in-person)

Follow-up

Participants are monitored for reduction in soft tissue swelling and other outcomes post-operatively

12 months

Multiple visits at 1, 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• AlloWrap® Amniotic Membrane

Trial Overview The trial tests AlloWrap Amniotic Membrane's effectiveness in reducing soft tissue swelling after two-level Anterior Cervical Discectomy and Fusion (ACDF) procedures. Participants will receive this membrane during their scheduled surgery to see if it helps decrease inflammation better than standard surgical practices without AlloWrap.

How Is the Trial Designed?

Group I: AlloWrap Group Experimental Treatment 1 Intervention

AlloWrap used in surgery

Group II: Standard of Care Group Active Control 1 Intervention

Standard of Care - No AlloWrap used during surgery

Who Is Running the Clinical Trial?

AlloSource

Lead Sponsor

Trials

10

Recruited

700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04684901?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22AlloSource%22)&viewType=Table&rank=7

Study Details | NCT04684901 | Effectiveness of AlloWrap® ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. trial.medpath.com trial.medpath.com/clinical-trial/3a6bd0563ce48d62/nct04684901-randomized-controlled-allowrap-amniotic-membrane-post-operative-soft-tissue-inflammation

Effectiveness of AlloWrap® for the Reduction of Inflammation ... Using AlloWrap® as a surgical barrier may result in outcomes with less scaring, potentially reducing pain and assisting the patient in returning to normal ...

3. allosource.org allosource.org/allosource-announces-first-patients-implanted-with-allowrap-amniotic-membrane-in-clinical-study-for-two-level-anterior-cervical-discectomy-and-fusion-procedures/

AlloSource Announces First Patients Implanted With ... The primary objective of this study is to obtain evidence of the effectiveness of AlloWrap Amniotic Membrane in the reduction of soft tissue ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10025852/

The Effect of Amniotic Tissue on Spinal Interventions Amnion products have shown promising effects in reducing epidural adhesions and scar tissue after spine surgery, improving spinal fusion rate and postoperative ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40047144/

Outcome After Anterior Cervical Decompression and ... Shorter preoperative pain duration, lower NDI scores, and nonsmoking status were significant predictors of good outcomes at 12 months after ACDF surgery for ...

6. prnewswire.com prnewswire.com/news-releases/allosource-announces-first-patients-implanted-with-allowrap-amniotic-membrane-in-clinical-study-for-two-level-anterior-cervical-discectomy-and-fusion-procedures-301233837.html

AlloSource Announces First Patients Implanted With ... The primary objective of this study is to obtain evidence of the effectiveness of AlloWrap Amniotic Membrane in the reduction of soft tissue ...