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Amputation-Site Soft-Tissue Restoration Using Adipose Stem Cell Therapy

Bourne, Debra A., M.D.; Thomas, R. Dallin, D.O., M.P.H.; Bliley, Jacqueline, M.S.; Haas, Gretchen, Ph.D.; Wyse, Aaron, M.D.; Donnenberg, Albert, Ph.D.; Donnenberg, Vera S., Ph.D.; Chow, Ian, M.D.; Cooper, Rory, Ph.D.; Coleman, Sydney, M.D.; Marra, Kacey, Ph.D.; Pasquina, Paul F., M.D.; Rubin, J. Peter, M.D.

Plastic and Reconstructive Surgery: November 2018 - Volume 142 - Issue 5 - p 1349–1352
doi: 10.1097/PRS.0000000000004889
Reconstructive: Lower Extremity: Ideas and Innovations

Summary: Soft-tissue deficits in amputation stumps can lead to significant pain and disability. An emerging treatment option is stem cell–enriched fat grafting. This is the first study assessing the potential for this treatment modality in lower extremity amputation sites. In this prospective cohort study, five injured military personnel suffering from pain and limited function at amputation sites were recruited. Fat grafting enriched with stromal vascular fraction was performed at amputation sites to provide additional subcutaneous tissue padding over bony structures. Outcomes measures included complications, demographic data, physical examination, cellular subpopulations, cell viability, graft volume retention, pain, Lower Extremity Functional Scale, Functional Mobility Assessment, 36-Item Short-Form Health Survey, and rates of depression. Follow-up was 2 years. There were no significant complications. Volume retention was 61.5 ± 24.0 percent. Overall cell viability of the stromal vascular fraction was significantly correlated with volume retention (p = 0.016). There was no significant correlation between percentage of adipose-derived stem cells or number of cells in the stromal vascular fraction and volume retention. There was a nonsignificant trend toward improvement in pain scores (3.0 ± 2.5 to 1.2 ± 1.6; p = 0.180 at 2 years). There were no significant changes in disability indexes. Results from this pilot study demonstrate that stromal vascular fraction–enriched fat grafting is a safe, novel modality for the treatment of symptomatic soft-tissue defects in traumatic lower extremity amputations. Volume retention can be anticipated at slightly over 60 percent. Further studies are needed to assess efficacy.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Pittsburgh, Pa.; Bethesda, Md.; and New York, N.Y.

From the Departments of Plastic Surgery, Psychiatry, Radiology, Rehabilitation Science and Technology, and Bioengineering, University of Pittsburgh; the VA Pittsburgh Healthcare System; the University of Pittsburgh McGowan Institute of Regenerative Medicine; the Department of Physical Medicine and Rehabilitation, Walter Reed National Military Medical Center; and New York University Langone Medical Center.

Received for publication September 11, 2017; accepted April 9, 2018.

This trial is registered under the name “Enriched Autologous Fat Grafting for Treating Pain at Amputation Sites (AMP-5),” ClinicalTrials.gov identification number NCT01645722 (https://clinicaltrials.gov/ct2/show/NCT01645722).

Presented at the 60th Annual Meeting of the Ohio Valley Society of Plastic Surgeons, in Pittsburgh, Pennsylvania, June 2 through 4, 2017; the Robert H. Ivy Pennsylvania Plastic Surgery Society Annual Meeting, Philadelphia, Pennsylvania, April 22, 2017; and Plastic Surgery The Meeting 2017, Annual Meeting of the American Society of Plastic Surgeons, in Orlando, Florida, October 6 through 10, 2017.

Disclosure: Dr. Coleman developed the cannulas used during fat grafting procedures performed during this study. The authors have no financial interest to declare in relation to the content of this article.

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J. Peter Rubin, M.D., Scaife Hall, Suite 6B, 3550 Terrace Street, Pittsburgh, Pa. 15261, rubinjp@upmc.edu

©2018American Society of Plastic Surgeons