CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Enhanced Fat Grafting +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02076022
NCT02076022N/ACompleted
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Adipose Stromal Cell Enriched Autologous Fat Grafting for Treating Pain at Amputation Sites: A Single Center Site, Prospective, Randomized, Pilot Outcomes Trial

J. Peter Rubin, MD·interventional·Posted Mar 3, 2014·Updated Nov 10, 2020

In Brief

A clinical study evaluating Enhanced Fat Grafting and Standard fat graft for Wounded Warrior and 2 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed Summary

We propose a prospective, randomized clinical study to assess the efficacy of minimally invasive autologous fat transfer addressing pain and poor prosthetic fit at amputation sites.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWounded Warrior, Limb Shortening, Amputation
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 3, 2014
Enrollment StartApr 8, 2014
Primary CompletionJul 18, 2018
Study CompletionJan 28, 2019
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 12.3 years ago

Interventions

Enhanced Fat Graftingdevice

The stromal vascular fraction (SVF) cell suspension (device output) will be processed using the Tissue Genesis Cell Isolation System™ The Standard graft material and the stromal vascular fraction cells will be mixed and subsequently injected into the amputated stump at a concentration of 2.0 - 3.0 x 10 6 stromal vascular cells/ml of injected fat graft to each site. The volume of each injected fat graft will depend on the volume requirements for each injured extremity. To manually combine the standard fat graft material and the SVF suspension (device output), each of the syringes will be connected via luer to luer lock. The contents of the lipoaspirate syringe are transferred to the SVF syringe and the cell suspension will be injected slowly back and forth between the two (2) syringes. The final 1 mL SVF-fat graft syringe is now considered cell-enriched and ready for injection into the subject.

Standard fat graftprocedure

Aspirated fat tissue will be processed as standard graft material. It will be divided into small aliquots and centrifuged in a sterile rotor (3000 rpm for 3 minutes/1200g), and top fluid oil layer from the fat tissue fractions were removed, and transferred into 1ml syringes and injected into the amputation stump. This graft preparation will be performed in the operating room. Standard fat graft material will serve as a control treatment and will be injected into limb using specialized injection cannulas