Pain Clinical Trial
— AMP-5Official title:
Enriched Autologous Fat Grafting for Treating Pain at Amputation Sites
Verified date | October 2017 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this pilot study is to assess the efficacy of minimally invasive autologous
fat transfers at the amputation sites and the modulation of pain at the respective sites. Our
investigators hypothesize that autologous fat grafting can provide a minimally invasive
therapy to effectively mitigate pain syndromes at amputation sites, by introducing volume
stable subcutaneous tissue over bony prominences and peripheral nerve trunks, thereby
avoiding major surgical revisions and preserving limb length. The investigators further
hypothesize that enriching the fat graft with autologous adipose stromal cells, a
regenerative medicine approach, will lead to improved retention of the fat graft over time
and result in a more favorable outcome.
The Investigators will evaluate:
1. Treatment of painful amputation sites in 5 patients with fat grafting, intended 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.
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. 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. Quality of life measurements in patients before and after autologous fat grafting using
validated psychosocial measures. This will include SF 36, the Beck inventory, and
instruments designed for assessing limb function.
Status | Completed |
Enrollment | 5 |
Est. completion date | September 14, 2016 |
Est. primary completion date | September 14, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Aged 18 years or older and able to provide informed consent 2. Have suffered injury resulting in 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 3. Be at least 3 months post-injury or post-surgery (from trauma procedures) so that acute edema is resolved 4. Soft tissue deficiencies are noted at amputation stump and are covered by intact skin 5. Willing and able to comply with follow up examinations, including radiographic studies 6. Active military 7. Able to provide informed consent Exclusion Criteria: 1. Age less than 18 years 2. Patient has inability to provide informed consent process. 3. Amputated limb area intended for treatment has open wounds, tunneling or drainage with active infection unresolved with one course of antibiotic treatment. 4. Active infection anywhere in the body 5. Diagnosed with cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment 6. Known coagulopathy symptoms /diagnosis 7. Systemic disease that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the patient. 8. Pregnancy 9. History of Diabetes Mellitus 10. History of severe peripheral arterial disease 11. Diagnosis of Schizophrenia or Bipolar Disorder (Subjects who are found to be stable on medication and receive psychiatric clearance could be eligible for study participation per the Physician's discretion). |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | United States Department of Defense |
United States,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment of Painful Amputation Sites | 1) Treat painful amputation sites in 5 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. Patients will be enrolled who have pain at an amputation site that limits function and/or interferes with the ability to use a prosthesis. | 26 months | |
Secondary | Assessment of biological cell properties within fat graft | Assess biologic properties of cells within the fat graft and correlate with clinical outcomes to 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. Assay results to be correlated with graft volume retention to search for predictors of good clinical outcome that are related to variation on adipose biology between subjects. Banked cells are stored for current assay or assay developed at a FUTURE date for correlation. | 20 years | |
Secondary | Quality of Life improvement | Measure quality of life in patients before and after autologous fat grafting using validated psychosocial measures. This will include SF 36, the Beck inventory, and instruments designed for assessing limb function. | 26 months |
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