Catarina Hadamitzky, Tatiana S. Zaitseva, Nathan Katz, Claire P Edelstein, Manuel T. Escarraman, Dung Nguyen, Michael V. Paukshto

Clinic of Plastic, Aesthetic and Hand Surgery, Helios Clinic, Hildesheim, Germany.

Fibralign Corporation, Union City, California, USA.

JointechLabs, Inc, N. Barrington, Illinois, USA.

Instituto Oncológico Dr. Heriberto Pieter, Santo Domingo, Dominican Republic.

Department of Plastic Surgery, Stanford University, Stanford, California, USA.

To address the limitations of current treatments for secondary lymphedema, our study group developed an experimental surgical procedure based on Autologous Lymph Node Fragment (ALNF) transfer supplemented by nanofibrillar collagen scaffold with and without autologous Adipose-Derived Stromal Cells out from the stromal vascular fraction (ADSCs). The efficacy of this scaffold was demonstrated before in a porcine model of secondary lymphedema. To address the challenges of poor survival and low migration from the injection site described in clinical studies of ADSCs, we used ADSC-seeded scaffolds to deliver the cells. These scaffolds seem to support cell survival, maintenance, and function at the targeted site. The ongoing pilot study has 12 patients currently enrolled. We used non-vascularized autologous lymph node fragment transfer (LNFT) as a basic treatment for all patients. It was supplemented by implantation of: BioBridge scaffolds (n=5); BioBridge scaffolds with ADSCs (n=2); BioBridge scaffolds with injected ADSCs (n=1); and injected ADSCs only (n=4; control group still ongoing). In the therapy groups, no complications have been reported after almost one year. 6 of 8 patients using BioBridge responded to the treatment after 6 months with an average volume reduction of about 20%. Two of these patients have attained a normal limb volume ratio (≤1.1) at 3 months after surgery. The average edema reduction in the control group (n=4) was only 1.1% 4 months after surgery. More data will be presented at the time of the conference. While vascularized lymph node transfer is considered to be a more advanced technique than ALNF transfer, there is a great interest in developing countries to have simpler surgery to manage lymphedema without the need for a microscope. On the other hand, the concept of guiding lymphangiogenesis with collagen scaffolds could also potentially improve the efficiency of well-established vascularized lymph node procedures.