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The purpose of this study is to assess local tissue reaction and retention of an adipose allograft extracellular matrix at 3 or 6 months post-injection into the subcutaneous abdominal tissue of healthy volunteers scheduled to undergo elective panniculectomy.
This is a prospective, randomized, two arm, single center study to assess adipose tissue development and retention when an implantable allograft adipose matrix ('AAM') is injected in the abdominal subcutaneous tissue of healthy volunteers undergoing elective standard-of-care panniculectomy. This study will enroll ten (10) subjects. These subjects will be randomized to one of two study arms. Arm 1 will consist of five (5) subjects who will receive injections of AAM to be followed clinically for three (3) months duration, and arm 2 will consist of five (5) subjects who will receive injections of AAM to be followed clinically for six (6) months duration. At the point of completion of each arm, 3 or 6 months, the injected tissue will be surgically removed as part of the panniculectomy procedure. Samples of the AAM injected tissue areas and surrounding tissue will be obtained and processed for histologic evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 Mo. Post AAM Injection | Experimental | Injection. Adipose Allograft Extracellular Matrix (AAM). Panniculectomy post injection, 3 months. |
|
| 6 Month Post AAM Injection | Experimental | Injection. Adipose Allograft Extracellular Matrix (AAM). Panniculectomy post injection, 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adipose Allograft Extracellular Matrix (AAM) Injection | Procedure | Injection followed by surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Histopathology evaluation for number of mature adipocytes via haematoxylin and eosin staining. | Change from baseline to 6 months in abdominal tissue samples using H & E staining | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of allograft adipose matrix (AAM) injections as determined by the incidence of adverse events. | Ongoing analysis of adverse events collected for the duration of a subject's participation and ongoing aggregate analysis of all subjects' adverse events. These endpoints will not be tested statistically unless unusual or unexpected results are obtained. | 6 months |
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Inclusion Criteria
Exclusion Criteria:
Study Population Description: Patients scheduled to undergo elective abdominoplasty Sampling Method: Invitation to volunteer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Philadelphia | Pennsylvania | 15261 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20304481 | Background | Flynn LE. The use of decellularized adipose tissue to provide an inductive microenvironment for the adipogenic differentiation of human adipose-derived stem cells. Biomaterials. 2010 Jun;31(17):4715-24. doi: 10.1016/j.biomaterials.2010.02.046. Epub 2010 Mar 20. | |
| 21043998 | Background | Brown BN, Freund JM, Han L, Rubin JP, Reing JE, Jeffries EM, Wolf MT, Tottey S, Barnes CA, Ratner BD, Badylak SF. Comparison of three methods for the derivation of a biologic scaffold composed of adipose tissue extracellular matrix. Tissue Eng Part C Methods. 2011 Apr;17(4):411-21. doi: 10.1089/ten.TEC.2010.0342. Epub 2011 Feb 5. |
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Decision to be made at study site appointment
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| 22327888 | Background | Wu I, Nahas Z, Kimmerling KA, Rosson GD, Elisseeff JH. An injectable adipose matrix for soft-tissue reconstruction. Plast Reconstr Surg. 2012 Jun;129(6):1247-1257. doi: 10.1097/PRS.0b013e31824ec3dc. |
| 25446266 | Background | Omidi E, Fuetterer L, Reza Mousavi S, Armstrong RC, Flynn LE, Samani A. Characterization and assessment of hyperelastic and elastic properties of decellularized human adipose tissues. J Biomech. 2014 Nov 28;47(15):3657-63. doi: 10.1016/j.jbiomech.2014.09.035. Epub 2014 Oct 7. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |