BioBridge plus vascularized lymph node transfer for arm lymphedema

Prospective Evaluation of Combination Therapy for Upper Extremity Lymphedema

This trial will test whether adding a BioBridge scaffold to vascularized lymph node transfer helps people with upper-arm lymphedema drain fluid and reduce swelling.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Stanford University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Palo Alto, California)
• Trial ID: NCT05825157 on ClinicalTrials.gov

What this trial studies

Adults with secondary upper-extremity lymphedema who are eligible for surgery will receive vascularized lymph node transfer (VLNT) with the BioBridge scaffold placed to promote lymphatic reconnection to the transplanted nodes. Outcomes such as limb volume, lymphatic drainage, and surgical viability will be monitored over time to see if the scaffold improves results compared with expected VLNT outcomes. Participants must have stage I–II lymphedema, have completed at least 12 weeks of complete decongestive therapy including consistent compression use, and meet cancer-free criteria where applicable. The intervention builds on positive results in large-animal models and is being tested at a single center (Stanford Hospital and Clinics).

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–75 with stage I–II upper limb lymphedema who are eligible for VLNT, have completed at least 12 weeks of complete decongestive therapy, and meet the study's cancer‑free/no evidence of disease requirements where applicable.

Not a fit: Patients with late-stage (stage III) or fibrotic/irreversible disease, bilateral involvement, active cancer, life expectancy under two years, or who are not surgical candidates are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the combination could increase the success rate of lymph node transfer, improve lymph drainage, and reduce arm swelling and related symptoms.

How similar studies have performed: BioBridge demonstrated efficacy in large-animal studies and VLNT has been used clinically with mixed results, but the human use of BioBridge combined with VLNT is novel and not yet widely proven.

Eligibility criteria

Inclusion Criteria:

* Ages 18 to 75 years (inclusive)
* Life expectancy \> 2 years
* Upper limb lymphedema
* The participant must be eligible for surgical intervention
* Swelling of 1 limb that is not completely reversed by elevation or compression
* Stage I-II lymphedema at screening, based on the International Society of Lymphology (ISL) staging system
* Participants with a history of cancer must have no evidence of disease (NED), have completed breast cancer therapy 3 years prior to enrollment; use of endocrine therapy is allowed.
* Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 12 weeks prior to screening, including use of compression garments for at least 12 weeks without change in regimen
* 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.
* Consistent use of an appropriately sized compression garment for daytime use.
* Limb volume (LV) in the affected limb and unaffected limb must be at least 10% of each other.
* Evidence of abnormal bioimpedance ratio, if feasible, based upon unilateral disease: L Dex \> 10 units.
* Willingness and ability to comply with all study procedures, including measurement of limb volume, skin biopsy, and preoperative and postoperative imaging studies.
* Willingness and ability to understand, and to sign a written informed consent form document

Exclusion Criteria:

* Edema arising from increased capillary filtration will be excluded (venous incompetence).
* Inability to safely undergo general anesthesia and/or perioperative care related to vascularized lymph node transfer
* Concurrent participation in a clinical trial of any other investigational drug or therapy, regardless of indication, within 1 month before screening or 5 times the drug's half life, whichever is longer
* Recent initiation (≤ 12 weeks) of CDPT for lymphedema
* Other medical condition that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure
* Other medical condition that could result in symptoms overlapping those of lymphedema in the affected limb (e.g., pain, swelling, decreased range of motion)
* History of clotting disorder (hypercoagulable state)
* Chronic (persistent) infection in the affected limb
* Infection of the lymphedema limb within 1 month prior to screening
* Currently receiving chemotherapy or radiation therapy
* Body Mass Index (BMI) \>35
* Known sensitivity to porcine products
* Anaphylaxis to iodine
* Pregnancy or nursing
* Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening
* Any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study.

Where this trial is running

Palo Alto, California

• Stanford Hospital and Clinics — Palo Alto, California, United States (Recruiting)

Study contacts

• Study coordinator: Dung Nguyen, MD, PharmD

Conditions Lymphedema Arm