AMP30: Autologous Fat Grafting, Amputation Sites Pain: Randomized



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:10/17/2018
Start Date:April 8, 2014
End Date:July 30, 2019

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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

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.

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.

Specific Aims:

1. 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.

2. 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.

3. 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.

Study Design:

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.

Clinical Impact:

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.

Inclusion Criteria:

- 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

- Be at least 3 months post-injury or post-surgery (from trauma procedures) so that
acute edema is resolved

- Soft tissue deficiencies are noted at amputation stump and are covered by intact skin

- Willing and able to comply with follow up examinations, including radiographic studies

- Subjects who are, in the opinion of the Investigator, able to understand the study,
comply with the study design and are willing to return to the clinic for all the
research required follow-up visits

- Subjects with residual limb problems including upper and lower limb loss, and/or
individuals with partial hand, partial foot and more proximal injuries.

- Subjects with Intolerability that may include appropriate soft tissue padding, soft
tissue coverage, or pain that doesn't allow the consistent wearing of a prosthetic
socket. (This may include excessive pain, inability to achieve adequate suspension of
prosthesis on the individual, continual skin breakdown, excessive pressure/shear on
skin, soft tissue, nerves, scars, etc.) and/or Subjects with Intolerability that
limits use of an assistive device(s) that aid mobility of daily living activities
involving the functional use of affected limb.

- Subjects who are unable to consistently wear a prosthetic socket must have received a
minimum of 3 months of unsuccessful prosthetic fitting trials. This will include a
minimum of at least 5 different socket adjustments. This can include re-casting the
residual limb, providing pressure relieves within the socket, changing the alignment
of the prosthetic components to alter ground reactive forces, and adding padding to
pressure sensitive areas. Likewise, subjects using assistive devices must have
received a minimum of 3 months of unsuccessful assistive device adjustments. This
information pertaining to the history of prosthetic fit attempts may be received from
referral physician, prosthetics and/or orthotics direct report and/or subject
self-report and/or medical record review.

- Subjects should have an approximate range of the defect volume between 5cc to as much
as 300cc. if the defect is a very local soft tissue deficiency over a pressure point.
(The volume of the defect correlates with moderate or severe intolerability of the
prosthesis)

- Subjects must have a current relationship with a prosthetist and/or Assistive device
Technician.

- Subjects who have a history of cancer to an affected limb that results in a surgical
amputation maybe eligible.

- Subjects who have a history of embolus to the affected limb that results in surgical
amputation maybe eligible

Exclusion Criteria:

- 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

- Subjects who per the clinical discretion of the investigator, would not be appropriate
for the study. (e.g. a potential medication and/ or medical diagnosis that is not
captured in above exclusion, but which could render the subject's participation in the
study unsafe, or would have an adverse effect on fat metabolism or fat healing).
We found this trial at
2
sites
4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Phone: 412-641-8676
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Pittsburgh, PA
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials