VLNT + BioBridge for Lymphedema

Recruiting at 2 trial locations

Overseen By Scully Hsu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fibralign Corporation

Must not be taking: Chemotherapy, Radiation therapy

Disqualifiers: Heart failure, Clotting disorder, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding BioBridge® Collagen Matrix to standard surgery can improve treatment for lymphedema, a condition that causes arm swelling after breast cancer treatment. It compares two groups: one receiving only the surgery and another receiving the surgery plus BioBridge. Ideal participants are breast cancer survivors with swelling in one arm not fully relieved by elevation or compression. Participants should be willing to follow a self-care routine and not have any other conditions causing limb swelling. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future lymphedema treatment options.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently receiving chemotherapy or radiation therapy, or if you are in another clinical trial.

What prior data suggests that the BioBridge® Collagen Matrix device is safe for use in lymphedema treatment?

Research has shown that using the BioBridge Collagen Matrix with a procedure called vascularized lymph node transfer (VLNT) might be safe for treating lymphedema in the upper arm. In earlier studies, patients who received BioBridge with their surgery did not experience serious side effects. Most participants tolerated the treatment well, without adverse reactions.

BioBridge is not entirely new. It has been used with VLNT in other studies, suggesting it is generally safe. While side effects can occur with any medical procedure, current evidence indicates that adding BioBridge to VLNT does not raise major safety concerns. Always discuss the risks and benefits with a doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for lymphedema, like compression therapy and manual lymphatic drainage, focus on managing symptoms rather than addressing the root cause. Vascularized Lymph Node Transfer (VLNT) is unique because it involves transplanting healthy lymph nodes to the affected area, potentially restoring natural lymphatic function. Researchers are particularly excited about the addition of BioBridge, a collagen matrix that supports the transplanted lymph nodes, which may enhance the effectiveness of VLNT by providing structural support and promoting tissue integration. This combination offers a promising approach to not just alleviate symptoms but to potentially reverse the underlying issue.

What evidence suggests that the BioBridge device is effective for improving surgical outcomes in lymphedema?

This trial will compare two treatment approaches for lymphedema. One group will receive Vascularized Lymph Node Transfer (VLNT) surgery alone. Studies have shown that VLNT can encourage lymph fluid movement to the affected area, speeding up arm healing. The other group will receive VLNT surgery supplemented by BioBridge, a mesh made from pig collagen. BioBridge is designed to support the growth of new lymph vessels, potentially enhancing surgical outcomes. Early research suggests that combining these treatments could lead to better outcomes for patients with lymphedema in the upper arm. ^{1 3 4 6 7}

Who Is on the Research Team?

Rebecca Garza, MD

Principal Investigator

The University of Chicago Medicine & Biological Sciences

David W Chang, MD, FACS

Principal Investigator

The University of Chicago Medicine & Biological Sciences

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors aged 18-75, free of cancer for 3 years, with Stage I-II upper arm lymphedema after treatment. They must have completed decongestive therapy and be willing to wear compression garments consistently. Exclusions include clotting disorders, severe kidney or liver issues, recent infections in the affected limb, current chemotherapy/radiation, high BMI (>35), pregnancy/nursing, substance abuse history within 6 months.

Inclusion Criteria

Evidence of abnormal bioimpedance ratio, if feasible, based upon unilateral disease: L Dex > 10 units.

I have swelling in my arm due to breast cancer treatment.

Willingness to comply with recommended regimen of self care, with consistent use of compression garments from screening through the entire study duration (through the safety follow up visit), excluding the first 3 weeks postoperatively where patients are required to not wear compression. Self bandaging, use of nighttime compression garments, and intermittent pneumatic compression devices are allowed, but the procedures and regimens are expected to remain consistent from screening though the entire study duration.

Exclusion Criteria

You have used drugs or alcohol excessively in the past 6 months.

I am currently undergoing chemotherapy or radiation therapy.

My swollen limb was infected within the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Participants undergo vascularized lymph node transplant surgery (VLNT) with or without BioBridge Collagen Matrix implantation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in excess limb volume, quality of life, lymphatic function, and histological architecture

12 months

Regular visits (in-person) for assessments

What Are the Treatments Tested in This Trial?

Interventions

• BioBridge® Collagen Matrix
• Vascularized Lymph Node Transfer (VLNT)

Trial Overview The LymphBridge study tests if adding BioBridge Collagen Matrix to standard vascularized lymph node transfer surgery improves outcomes for those with breast cancer-related upper arm lymphedema. Participants will undergo surgical intervention and follow-up care to assess the effectiveness of this combined treatment approach.

How Is the Trial Designed?

Group I: BioBridge treatment group Experimental Treatment 2 Interventions

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

Group II: Control group Active Control 1 Intervention

Vascularized Lymph Node Transplant surgery (VLNT) only

Vascularized Lymph Node Transfer (VLNT) is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Vascularized Lymph Node Transfer for:

• Upper extremity lymphedema
• Lower extremity lymphedema

Approved in European Union as Vascularized Lymph Node Transfer for:

• Upper extremity lymphedema
• Lower extremity lymphedema
• Breast cancer-related lymphedema

Approved in Canada as Vascularized Lymph Node Transfer for:

• Upper extremity lymphedema
• Lower extremity lymphedema

Approved in Japan as Vascularized Lymph Node Transfer for:

• Upper extremity lymphedema
• Lower extremity lymphedema

Who Is Running the Clinical Trial?

Fibralign Corporation

Lead Sponsor

Trials

2

Recruited

120+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05695924

Surgical Evaluation for Upper Extremity Lymphedema ... The study will investigate whether addition of the BioBridge Collagen Matrix to the standard surgery for vascularized lymph node transfer will improve the ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2352587824001888

Long-term results of lymphedema treatment with Combined ... Vascularized lymph node transfer (VLNT) accelerates growth factor secretion, lymphatic endothelial cell migration toward the interstitial flow and ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05825157

Prospective Evaluation of Combination Therapy for Upper ... Will Biobridge improve upon the low success rate of the currently practiced surgery by facilitating the lymphatic connections to the transplanted node that are ...

4. withpower.com withpower.com/trial/phase-lymphedema-2-2023-55e85

BioBridge + VLNT for Lymphedema This trial is testing if adding BioBridge, a biodegradable mesh made from pig collagen, to standard surgery can help patients with upper arm lymphedema.

5. mdpi.com mdpi.com/2076-3417/13/20/11571

Lymphedema Surgical Treatment Using BioBridgeTM The use of collagen scaffolds to promote lymphangiogenesis in the surgical routine could improve the outcome of microsurgical procedures in ...

6. plasticsurgery.stanford.edu plasticsurgery.stanford.edu/research/trials.html?ctid=NCT04606030&conditionId=&serviceLineId=&condition=&alpha=l

Clinical Trials | Division of Plastic & Reconstructive Surgery To investigate whether the addition of Fibralign's BioBridge® Collagen Matrix (BioBridge) devices to the standard surgery for vascularized lymph node transfer ...

7. mdanderson.org mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2021-0689.html

Clinical Trials Detail Study #2021-0689. Prospective Evaluation of the BioBridge Scaffold as an Adjunct to Lymph Node Transplant for Upper Extremity Lymphedema.