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Adipose Stem Cell Therapy for Amputation Site Soft Tissue Restoration: A Prospective Randomized Controlled Clinical Trial
Debra A. Bourne, Danielle Minteer, Aaron Wyse, Albert Donnenberg, Vera Donnenberg, Gretchen Haas, Rory Cooper, Sydney Coleman, Kacey Marra, Lauren Kokai, Paul Pasquina, J. Peter Rubin
University of Pittsburgh Medical Center
2019-02-12
Presenter: Debra A Bourne
Affidavit:
The submitted work represents original research completed by the presenting fellow and all co-authors and has not been previously published.
Director Name: Alexander Spiess
Author Category: Fellow Plastic Surgery
Presentation Category: Clinical
Abstract Category: General Reconstruction
Background: Nearly 2 million people in America suffer from limb loss. Challenges include skin break down, pain, and poor prosthesis fit. The aim of this study is to assess the efficacy of standard autologous fat transfer compared to fat graft enriched with adipose derived stem cells to improve lower extremity amputation site soft tissue quality and pain.
Methods: Patients suffering from pain and limited function at amputation sites were randomized to either the Standard Group treated with autologous fat grafting to the amputation site; or the Enriched Group which was enriched with concentrated adipose derived stem cells. Outcome measures included: 1) Pain reporting, 2) Cell populations via flow cytometry, and 3) Quality of life questionnaires.
Results: Study subjects were randomized (Enriched, n=3; Standard, n=7) and received treatment with no significant adverse events. Follow-up was two years. There was no significant difference in cell viability or cellular populations of the harvested fat between groups.
Subjects in the Enriched Group experienced significant improvement in pain, and earlier than the Standard Group (p=0.02). There was improvement in hypersensitivity, prosthetic fit, and pain at 1-month post-treatment, lasting through two years. Importantly, 6/10 subjects discontinued pain and/or anti-anxiety medication after fat grafting.
There was significant improvement in self-rated satisfaction with physical appearance (p=0.007) and a trend for improvement in self-rated freedom from pain.
Conclusions: Fat grafting improves pain, hypersensitivity, prosthesis fitting, and quality of life for patients suffering from lower limb amputation pain. Fat grafts enriched with adipose stromal cells may enhance pain relief.
