What is the mechanism of action of this treatment?

Lymphedema treatments often focus on improving lymphatic function and supporting tissue regeneration. The BioBridge® Collagen Matrix, for example, is designed to enhance the outcomes of vascularized lymph node transfer surgery by providing a scaffold that supports tissue regeneration and improves lymphatic function. This is achieved by promoting the growth of new lymphatic vessels and reducing fibrosis, which can help restore normal lymphatic drainage. For lymphedema patients, these mechanisms are crucial as they address the underlying issues of impaired lymphatic flow and tissue damage, potentially reducing swelling, pain, and the risk of infections.

What side effects are associated with this type of intervention?

Common treatments for lymphedema include Complete Decongestive Therapy (CDT), compression garments, and Intermittent Pneumatic Compression (IPC). CDT, which involves lymph drainage, compression bandaging, exercise, and skin care, generally has minimal severe adverse effects but may cause skin irritation or discomfort. Compression garments can also lead to skin irritation and discomfort. IPC is another method with generally minimal severe adverse effects, though it may cause temporary discomfort or bruising. Treatments like the BioBridge® Collagen Matrix, which support tissue regeneration, are still under investigation, but potential side effects could include local reactions such as redness, swelling, or infection at the application site.

What prior FDA approvals exist?

The FDA has granted orphan drug designation to ABCB5+ MSCs (allo-APZ2-EB) for the treatment of lymphedema, which supports tissue regeneration and improves lymphatic function. This treatment involves mesenchymal stem cells that have shown promise in reducing symptoms and improving clinical outcomes in early trials. Other treatments for lymphedema, such as hyaluronidase, have demonstrated efficacy in reducing lymphedema volume and enhancing lymphangiogenesis in preclinical models. While specific FDA approvals for treatments exactly like BioBridge® Collagen Matrix are not detailed, these examples reflect the ongoing efforts to develop regenerative therapies for lymphedema.

What other types of research exist?

Promising alternatives to BioBridge® Collagen Matrix for lymphedema treatment in 2024 include: 1) GNP-cross-linked CollaGee, a collagen-gelatin-elastin acellular skin substitute that enhances mechanical strength and biocompatibility, and 2) BioBlanket Surgical Mesh, a collagen-based surgical mesh that facilitates soft tissue repair. Both materials show potential in supporting tissue regeneration and improving lymphatic function.

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BioBridge + VLNT for Lymphedema

N/A

Recruiting

Research Sponsored by Fibralign Corporation

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 months after treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if adding BioBridge, a biodegradable mesh made from pig collagen, to standard surgery can help patients with upper arm lymphedema. The mesh supports new lymph nodes to improve fluid drainage and reduce swelling. BioBlanket Surgical Mesh, a collagen-based surgical mesh, has been evaluated for its potential to facilitate soft tissue repair in an animal model.

Who is the study for?

This trial is for breast cancer survivors aged 18-75 with Stage I-II upper limb lymphedema after treatment, who've completed a full course of decongestive therapy. Participants must be free of cancer for 3 years, have no severe organ dysfunction or clotting disorders, not be pregnant or nursing, and able to undergo surgery.

What is being tested?

The study tests if adding BioBridge® Collagen Matrix to standard vascularized lymph node transfer surgery improves outcomes in treating arm swelling due to lymphedema in breast cancer survivors.

What are the potential side effects?

Potential side effects may include reactions related to the surgical procedure such as infection, pain at the site of surgery, swelling beyond the preoperative condition, and possible allergic reactions to materials used.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 months after treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 12 months after treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months after treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Excess limb volume change

Secondary study objectives

Histology

ICG fluorescence imaging

L-Dex bioimpedance spectroscopy.

+1 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: BioBridge treatment groupExperimental Treatment2 Interventions

Vascularized Lymph Node Transplant surgery (VLNT) supplemented by BioBridge Collagen Matrix implantation

Group II: Control groupActive Control1 Intervention

Vascularized Lymph Node Transplant surgery (VLNT) only

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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

Lymphedema treatments often focus on improving lymphatic function and supporting tissue regeneration. The BioBridge® Collagen Matrix, for example, is designed to enhance the outcomes of vascularized lymph node transfer surgery by providing a scaffold that supports tissue regeneration and improves lymphatic function. This is achieved by promoting the growth of new lymphatic vessels and reducing fibrosis, which can help restore normal lymphatic drainage. For lymphedema patients, these mechanisms are crucial as they address the underlying issues of impaired lymphatic flow and tissue damage, potentially reducing swelling, pain, and the risk of infections.

Injectable and degradable methacrylic acid hydrogel alters macrophage response in skeletal muscle.Therapeutic effects of hyaluronidase on acquired lymphedema using a newly developed mouse limb model.Genistein Improves Skin Flap Viability in Rats: A Preliminary In Vivo and In Vitro Investigation.