AMP30: Autologous Fat Grafting, Amputation Sites Pain: Randomized (AMP30)
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|ClinicalTrials.gov Identifier: NCT02076022|
Recruitment Status : Completed
First Posted : March 3, 2014
Results First Posted : August 22, 2019
Last Update Posted : August 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Wounded Warrior Limb Shortening Amputation||Device: Enhanced Fat Grafting Procedure: Standard fat graft||Not Applicable|
We hypothesize that autologous fat grafting can provide a minimally invasive therapy facilitated by enabling technology of specialized instrumentation to effectively mitigate pain syndromes at amputation sites, by introducing volume stable subcutaneous tissue over bony prominences and peripheral nerve trunks, thereby avoiding surgical revisions and preserving limb length.
We further hypothesize that enriching the fat graft with autologous adipose stromal cells utilizing the Tissue Gensis Cell Isolation System (CIS), a regenerative medicine approach, will lead to improved retention of the fat graft over time and result in a more favorable outcome.
- Treat painful amputation sites in 30 patients with fat grafting to provide additional subcutaneous tissue padding over bony structures and nerve trunks. Limb anatomy and healing of the graft over time, along with stability/persistence of the new tissue, will be assessed by high resolution CT scanning with 3D reconstruction. Patients will be followed for 24 months after treatment to define long term outcomes. The primary outcome measures will be pain at the amputation site and improved ability to tolerate a prosthesis. Patients will be randomized to receive either standard fat grafting (15 patients)or cell enriched fat grafting (15 patients). Patients will be enrolled who have pain at an amputation site that limits function and/or interferes with the ability to use a prosthesis.
- Assess biologic properties of the cells within the fat graft and correlate with clinical outcomes. This will include adipose stem cell yield per volume of fat tissue, cell proliferation, capacity for adipogenic differentiation, lipolysis, and cell sub-population analysis by multiparameter flow cytometry. Results of these assays will be correlated with graft volume retention to search for predictors of good clinical outcome that are related to variation on adipose biology between subjects.
- Measure quality of life in patients before and after autologous fat grafting using validated psychosocial measures. This will include, among other tools, SF 36, the Beck inventory, and instruments designed for assessing limb function.
Single center site, prospective, randomized, pilot outcomes study with treatment performed at the University of Pittsburgh.
The primary outcome measurements will be: 1) fat graft retention at the amputation site; and 2) improved ability to tolerate a prosthetic device. This study will examine if fat grafting with cell enrichment using the Tissue Gensis Cell Isolation System, (CIS) will demonstrate increased fat retention and decreased pain compared to standard fat grafting alone.
This study will significantly impact military trauma care by validating a minimally invasive cell based technique for alleviating pain at amputation sites and improving function with a prosthesis. Importantly, the goal will be reached without invasive surgery, increased risk, and a prolonged recovery. Given the high amputation rate in the current conflicts, this work is highly relevant to the care of the wounded warrior. A major goal of this study will be to transfer the techniques and knowledge gained to physicians throughout the Department of Defense healthcare system.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Adipose Stromal Cell Enriched Autologous Fat Grafting for Treating Pain at Amputation Sites: A Single Center Site, Prospective, Randomized, Pilot Outcomes Trial|
|Actual Study Start Date :||April 8, 2014|
|Actual Primary Completion Date :||July 18, 2018|
|Actual Study Completion Date :||January 28, 2019|
Active Comparator: Standard fat grafting
Once harvested the 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
Procedure: Standard fat graft
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
Experimental: Enhanced Fat Grafting
Approximately 60 cc of lipoaspirate will be collected from the subject to be processed with the Tissue Genesis Cell Isolation System™ (CIS) to yield approximately 35cc of Stromal Vascular Fraction (SVF).Once harvested the aspirated fat will then be divided into two portions: one portion will be processed as standard graft material (standard/control graft) while the other portion will be used in a processing step that concentrates the adipose stromal cells.
The aspirated fat processed as standard graft material will be divided into small aliquots and centrifuged in a sterile rotor (3000 rpm for 3 minutes/1200g), and allowed to decant before separating the fluid and oil layers from the fat tissue fractions, and transferred into 50 ml syringes. This graft preparation will be performed in the operating room.
Device: Enhanced Fat Grafting
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.
Other Name: Tissue Genesis Cell Isolation System™ (CIS)
- Efficacy of Autologous Fat Transfer at Pain Modulation at Respective Amputation Sites [ Time Frame: 2 years ]
Assess the efficacy of minimally invasive autologous fat transfer at the amputation sites and the modulation of pain at the respective sites
Compare two minimally invasive techniques as an alternative to invasive operations, with the understanding that this therapy does not preclude more invasive procedures in the future. We further hypothesize that enriching the fat graft with autologous adipose stromal cells utilizing the Tissue Genesis Cell Isolation System (CIS), a regenerative medicine approach, will lead to improved retention of the fat graft over time and result in a more favorable outcome.
Subjects reported pain on a scale of 0-5 where 5 was the worst pain and 0 was no pain.
- Cell Yield [ Time Frame: day 0 ]To assess biologic properties of the cells within the fat graft, we evaluated adipose stem cell viability by multiparameter flow cytometry.
- Number of Participants With Clinically Significant Levels of Depression on the Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 2 years ]Measure quality of life in patients before and after autologous fat grafting using validated psychosocial measures. This will evaluate using instruments designed for assessing depression including the Patient Health Questionnaire-9 (PHQ-9) which is a tool to screen, diagnose, monitor, and measure the severity of depression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076022
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Joseph P Rubin, MD||University of Pittsburgh|