BioBridge + VLNT for Lymphedema

Overseen By Shannon Meyer

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: 13

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to treating lymphedema (swelling due to fluid build-up) in the upper arm, which can occur after breast cancer treatment. Researchers are testing whether adding the BioBridge® Collagen Matrix to the standard surgery, Vascularized Lymph Node Transfer (VLNT), can improve outcomes. The trial includes two groups: one will receive the standard surgery plus BioBridge, while the other will undergo the standard surgery alone. Breast cancer survivors who completed treatment over three years ago and still experience swelling in one arm that doesn't fully resolve with elevation or compression might be suitable candidates. As an unphased trial, this study offers patients a unique opportunity to contribute to innovative research that could enhance future treatment options.

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

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

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

Research has shown that the BioBridge Collagen Matrix, when combined with Vascularized Lymph Node Transfer (VLNT), is generally well-tolerated. A study on treating lymphedema by combining lymph node transfer and collagen scaffolds, such as BioBridge, demonstrated good long-term results with manageable side effects. The BioBridge device, a biodegradable mesh made from pig collagen, has been safely used in medical procedures. These studies have reported no major safety issues, suggesting it is safe for humans. However, discussing potential risks with a healthcare provider before joining a trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of BioBridge and Vascularized Lymph Node Transfer (VLNT) for lymphedema because it introduces a new approach that may enhance the effectiveness of existing surgery. The BioBridge Collagen Matrix acts as a scaffold, potentially improving lymphatic drainage and promoting tissue repair when used alongside traditional VLNT surgery. This innovative use of a collagen matrix could lead to better outcomes and faster recovery for patients compared to VLNT alone, offering hope for more lasting relief from lymphedema symptoms.

What evidence suggests that the BioBridge device is effective for improving lymphedema treatment?

Research has shown that adding the BioBridge Collagen Matrix to vascularized lymph node transfer (VLNT) surgery can help treat lymphedema in the upper arm. In this trial, participants in the BioBridge treatment group will receive VLNT surgery with BioBridge Collagen Matrix implantation. One study found that using BioBridge, a biodegradable mesh, improved results by promoting the growth of new lymph vessels. Patients who received both BioBridge and VLNT experienced better long-term outcomes in managing lymphedema, such as reduced swelling. The collagen structure in BioBridge aids the healing process, enhancing the surgery's effectiveness. Overall, this combined approach shows promise for people dealing with upper arm lymphedema. ^{1 3 4 5 6}

Who Is on the Research Team?

Dung H Nguyen, MD, PharmD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I finished my breast cancer treatment 3 years ago and currently have no signs of the disease.

Life expectancy > 2 years

Limb volume (LV) in the affected limb and unaffected limb must be at least 10% of each other

Exclusion Criteria

I have swelling due to fluid leakage from blood vessels.

I have not had an infection in my swollen limb in the last month.

I have a long-lasting infection in my limb.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Treatment

Participants undergo vascularized lymph node transplant surgery, with or without BioBridge Collagen Matrix implantation

1 week

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) over 12 months

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview 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.

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+

Published Research Related to This Trial

Vascularized lymph node transfer (VLNT) can significantly reduce the volume difference between affected and healthy arms in patients with breast cancer-related lymphedema by approximately 40%.

VLNT is associated with improved quality of life, a decrease in skin infection rates, and a notable number of patients (27 out of 60) being able to stop using compression garments, all while maintaining a low complication rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of vascularized lymph node transfer for breast cancer-related lymphedema. Winters, H., Tielemans, HJP., Paulus, V., et al.[2022]

The study evaluated a lymphatic drainage device (LDD) designed to effectively drain fluid into the venous system, showing that a 5 μm polyvinylidene difluoride membrane was the most efficient in draining fluid in vitro, with significant volume differences compared to smaller pore sizes.

In vivo testing in a rat model confirmed the LDD's ability to mimic vascularized lymph node transfer (VLNT) by successfully draining 5% albumin into the venous system, indicating potential for treating extremity lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy validation of a lymphatic drainage device for lymphedema drainage in a rat model. Cheng, MH., Yang, CY., Tee, R., et al.[2020]

In a systematic review of 18 studies involving 305 patients, free vascularized lymph node transfer (VLNT) showed significant postoperative improvements in lymphedema, with 91% of patients experiencing reduced limb circumference and 86% showing decreased limb volume.

Patient satisfaction was high, with 98% of surveyed patients reporting significant symptom relief and improved quality of life, alongside a noted reduction in infections, indicating VLNT's potential effectiveness and safety as a treatment for lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Free vascularized lymph node transfer for treatment of lymphedema: A systematic evidence based review. Ozturk, CN., Ozturk, C., Glasgow, M., et al.[2019]

The study identified an average of 5.2 lymph nodes in the level I neck region from 73 patients, providing essential anatomical data that can help optimize vascularized lymph node transfer (VLNT) surgeries for lymphedema treatment.

Current literature supports that level I neck lymph nodes are a reliable source for free lymph node transfer, making VLNT an effective surgical option for managing lymphedema while minimizing donor-site complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantification of level I neck lymph nodes for lymph node transfer in lymphedema treatment: an anatomical study and review of literature. Rozen, WM., Niumsawatt, V., Gibson, LD., et al.[2023]

Intra-abdominal vascularized lymph node transfer (VLNT) is an effective treatment for lymphedema, showing a mean reduction in limb circumference or volume of up to 70.8% across 21 studies involving 594 patients.

The procedure has a low complication rate, with only 1.4% for donor-site complications and 3.2% for recipient-site complications, indicating it is a safe option that does not impair lymph function at the donor site.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-abdominal vascularized lymph node transfer for treatment of lymphedema: A systematic literature review and meta-analysis. Li, Y., Dong, R., Li, Z., et al.[2021]

Vascularized bone transfer is an effective technique for reconstructing large bone defects in the upper limb, particularly beneficial for complex cases like infected nonunions and radionecrosis.

Despite its technical challenges, the positive outcomes of vascularized bone transfer make it a valuable option compared to other reconstruction methods for the humerus and shoulder region.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Massive bone defects of the upper limb: reconstruction by vascularized bone transfer. Wood, MB., Bishop, AT.[2007]

Vascularized bone segment transfer procedures are effective for treating chronic osteomyelitis, achieving control of infection in about 85% of patients who underwent extensive bone resection.

However, around 50% of patients required additional surgeries to achieve complete healing and bony union, indicating that while the procedure is beneficial, it may not always result in immediate success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascularized bone segment transfers for management of chronic osteomyelitis. Wood, MB., Cooney, WP.[2004]

Vascular loops (VL) are a viable option for reconstructive microsurgery when recipient vessels are damaged or unavailable, offering an alternative to interpositional vein grafts (VG) for connecting flaps to distant vessels.

While VL techniques may have advantages over VG, they generally show a lower success rate compared to direct anastomosis to recipient vessels, indicating the need for further research to optimize these methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Vascularloops in reconstructive microsurgery: A review of the literature]. Shipkov, H., Traikova, N., Voinov, P., et al.[2022]

Over a 4-year period, 33 patients received free vascularized bone transplants for extremity preservation, with 20 using fibula grafts and 13 using iliac crest grafts.

The success of these transplants was attributed to a comprehensive postoperative management plan that included blood-flow monitoring, skin flap raising, angiographic checks for anastomosis patency, and careful immobilization and mobilization strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Free vascularized bone transplantation]. Eisenschenk, A., Lehnert, M., Weber, U.[2016]

Vascularized lymph node transfer from the greater curvature of the stomach (VLNTg) is a promising surgical option for treating upper extremity lymphedema in breast cancer patients, with a review of 24 cases showing no complications and easily concealable scars.

Most patients (18 out of 24) had experienced lymphedema for over a year, yet VLNTg still resulted in significant improvements, indicating its efficacy even in long-standing cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascularized gastroepiploic lymph node transfer significantly improves breast cancer-related lymphedema. Mousavi, SR., Akbari, ME., Zarrintan, S.[2020]

In a study of 12 patients with lower extremity lymphedema, a combined surgical approach of vascularized lymph node transfer (VLNT) and lymphaticovenular anastomosis (LVA) resulted in significant improvements in limb circumference after an average follow-up of 12.9 months.

All surgical flaps survived without complications, and the majority of patients showed improvement in their lymphedema stage, suggesting that this combined method may enhance the effectiveness of treatment for lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary outcomes of combined surgical approach for lower extremity lymphedema: supraclavicular lymph node transfer and lymphaticovenular anastomosis. Chung, JH., Hwang, YJ., Park, SH., et al.[2022]

In a study of 100 patients undergoing vascularized lymph node transfer (VLNT), implantable Doppler monitoring demonstrated a 100% sensitivity and 97.9% specificity for detecting flap perfusion issues, indicating it is highly reliable for monitoring vascular health post-surgery.

The technique proved to be safe and effective, as all compromised flaps were successfully salvaged, with a low false-positive rate of only 2%, highlighting its potential for improving outcomes in free tissue transfer procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantable Doppler monitoring of buried free flaps during vascularized lymph node transfer. Teven, CM., Ooi, ASH., Inbal, A., et al.[2017]

In a study of 100 patients undergoing supraclavicular vascularized lymph node transfer (VLNT) for lymphedema, there were no cases of flap loss, indicating a high level of surgical success and safety.

The procedure demonstrated low morbidity, with only 3% of flaps requiring re-exploration for venous congestion and a few cases of local infection and chyle leak that resolved spontaneously, making it a promising option for lymphedema treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of supraclavicular free flap with vascularized lymph node transfer for treatment of lymphedema: A prospective study of 100 consecutive cases. Maldonado, AA., Chen, R., Chang, DW.[2022]

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 ... Original Article. Long-term results of lymphedema treatment with Combined lymph node transfer and collagen scaffolds: An Observational Study.

3. 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.

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 ...