Trials Sponsors Conditions Drugs Pricing

Conditions

Amputation Limb Shortening Wounded Warrior

Keywords

Fat GraftingPain at amputation siteprosthetic

Outcome Measures

Primary Outcomes (1)

Efficacy of Autologous Fat Transfer at Pain Modulation at Respective Amputation Sites
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.
2 years

Secondary Outcomes (2)

Cell Yield
day 0
Number of Participants With Clinically Significant Levels of Depression on the Patient Health Questionnaire-9 (PHQ-9)
2 years

Study Arms (2)

Standard fat grafting

ACTIVE COMPARATOR

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

Enhanced Fat Grafting

EXPERIMENTAL

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.

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.

Also known as: Tissue Genesis Cell Isolation System™ (CIS)

Enhanced Fat Grafting

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Aged 18 years or older and able to provide informed consent
Has an amputation with pain that limits the fitting and use of a prosthesis, despite maximal attempts to refit the prosthesis and/or change the design of the prosthesis and/or Have an amputation with pain that limits the use of an assistive device(s) despite maximal attempts to change the design of use of the device

Sponsors & Collaborators

J. Peter Rubin, MD
Otherlead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Results Point of Contact

Title: Patsy Simon
Organization: University of Pittsburgh Plastic Surgery

Study Officials

Joseph P Rubin, MD
University of Pittsburgh
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

10 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

February 27, 2014

First Posted

March 3, 2014

Study Start

April 8, 2014

Actual (reported)

You may not qualify if:

Age less than 18 years
Patient has inability to provide informed consent process.
Amputated limb area intended for treatment has open wounds or tunneling
Active drainage or active infection unresolved with one course of antibiotic treatment
Active infection anywhere in the body
Diagnosed with cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment
Known coagulopathy symptoms /diagnosis
Systemic disease that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the patient (e.g., scleroderma, lupus, vasculatures, collagen disease etc.)
Pregnancy
History of Diabetes Mellitus
History of severe peripheral arterial disease
Subjects with an Axis I DSM-IV diagnosis (e.g., Schizophrenia, Bipolar disorder) who are found to be clinically (i.e. medically) unstable at baseline. Individuals who manifest either: 1) evidence of currently active alcohol or psychoactive drug abuse or dependence on the SCID interview, or 2) a GAF score of 40 or lower due to any acute psychiatric symptomatology (e.g. suicidality, psychosis, severe depression or mania) will be reviewed by the Co-I for Psychosocial Assessment with the PI for determination of possible medical instability. Final determination of medically unstable status will be made by the PI on the basis of overall medical status and appropriateness for medical procedures; the patient may be considered ineligible for study participation per the Physician's discretion.
Subjects with abnormal blood biochemistry or any other abnormal laboratory finding considered clinically significant in that it would deem the subject inappropriate for surgical procedures. This criterion will help to exclude subjects with severe nutritional deficiency, anemia, coagulopathy, renal and liver dysfunction, diabetes, and peripheral vascular disease, as determined by the investigator (i.e. CBC with Differential, platelets, comprehensive metabolic panel to include electrolytes, bun/creatinine, liver function test and coagulation tests). As general safety measures, we will exclude patients with lab values listed below: Hct less than 30% INR greater than 1.8 Creatinine greater than 2.0 Liver function tests (ALT, AST, Bilirubin) greater than 2 times upper limit Albumin- Less than 2.0 Platelets less than 70

AMP30: Autologous Fat Grafting, Amputation Sites Pain: Randomized

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Standard fat grafting

Enhanced Fat Grafting

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Standard fat grafting

Enhanced Fat Grafting

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations