| Eligibility |
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.
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