What side effects are associated with this type of intervention?

The most common treatments for Anterior Cruciate Ligament (ACL) rupture, particularly those involving collagen-based membranes and mesenchymal stem cells (MSCs), can have several side effects. Collagen-based membranes may cause local irritation or allergic reactions. The use of MSCs, while generally safe, can lead to minor and transient risks such as pain, swelling, and bruising at the injection site. Additionally, there is a general risk of infection associated with any surgical procedure. Overall, these treatments aim to enhance graft maturation and strength, but patients should discuss potential risks and benefits with their healthcare provider.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved treatments for ACL rupture that directly utilize a collagen-based membrane as a barrier and scaffold for stem cells and growth factors. Traditional treatments for ACL rupture typically involve surgical reconstruction using autografts or allografts, and rehabilitation. Emerging therapies, such as the use of platelet-rich plasma (PRP) and mesenchymal stem cells (MSCs), are being investigated for their potential to enhance healing and improve outcomes, but these are not yet standard FDA-approved treatments for ACL injuries.

What other types of research exist?

A promising novel alternative to collagen-based membranes for ACL rupture treatment in 2024 is the biomimetic nanofibrous membrane. This membrane has shown effectiveness in improving tendon-bone healing and biomechanical properties in ACL reconstruction.

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Stem Cell Therapy

Bio ACL Reconstruction for Anterior Cruciate Ligament Rupture (BioACLRCT Trial)

N/A

Waitlist Available

Led By Adam Anz, MD

Research Sponsored by Andrews Research & Education Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months, 9 months, 12 months post-op

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a collagen membrane from amniotic tissue to help heal ACL reconstructions. It targets patients with slow or incomplete healing. The membrane keeps helpful cells and growth factors near the graft, speeding up recovery and strengthening the new ligament. Amniotic membranes are known for their anti-inflammatory, scaffolding, and stem cell-producing effects, which can aid in the healing process of ACL reconstructions.

Who is the study for?

This trial is for individuals aged 18-45 who are about to have ACL reconstruction with their own tissue grafts. They must be able to get MRI scans post-surgery and have internet access, an email address, and the ability to understand study documents.

What is being tested?

The trial is testing a collagen-based membrane from amniotic tissue wrapped around the reconstructed ACL, potentially with stem cells. This may speed up healing and strengthen the graft, allowing quicker return to sports.

What are the potential side effects?

Potential side effects aren't specified in this summary but could include typical surgical risks like infection or reaction to materials used in the wrap or complications related to MRI procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months, 9 months, 12 months post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months, 9 months, 12 months post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months, 9 months, 12 months post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in ACL

Secondary study objectives

Changes in Knee injury and Osteoarthritis Outcome Score (KOOS)

Changes in Short Form 12 (SF-12) patient ratings

Changes in Single Assessment Numerical Evaluation (SANE) patient ratings for function

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bio-ACL (Amion)Experimental Treatment1 Intervention

Intervention: ACL Autograft Reconstruction with Amion Collagen Scaffold. Stem Cells isolated from bone marrow aspirate from distal femur will be injected inside the Amion Collagen Scaffold.

Group II: ControlActive Control1 Intervention

Intervention: Normal ACL Autograft Reconstruction with either patella or hamstring autograft will be performed in the control group.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Anterior Cruciate Ligament (ACL) rupture, such as the use of collagen-based membranes, work by providing a scaffold that supports the containment and activity of autologous mesenchymal stem cells and growth factors. This scaffold helps reestablish the natural synovial lining and protects the graft from synovial fluid, thereby accelerating the maturation and strengthening of the implanted graft tissue. For ACL rupture patients, this mechanism is crucial as it can lead to faster and more robust healing, allowing for a safer and earlier return to sports and physical activities.