Autologous Volar Fibroblast Injection Into the Stump Site of Amputees

Eligibility Criteria

• * A skin erosion deeper than the skin dermis.
• * Having received any investigational drug within 30 days prior to study entry
• * An allergy history to any study materials including local anesthetic, dimethyl sulfoxide, human albumin, or bovine constituents, hetastarch, or EMLA (lidocaine 2.5% and prilocaine 2.5%).
• * Pregnant, lactating, or trying to become pregnant
• * A history of keloid formation
• * Having a significant medical history that the investigator feels is not safe for study participation (for example, some forms of autoimmune conditions, metastatic cancer, infectious diseases such as HIV, HTLV I/II, Hepatitis B, Hepatitis C). Biopsies taken from individuals with infections that are not allowed to enter the cell therapy core will make it such that these individuals cannot participate.
• * Specifically we will exclude those with autoimmune diseases affecting the skin such as lupus.
• * Presence of necrotic ischemic tissue on any stump ulcers, and/or capillary refill on stump skin of greater than 3 seconds
• * Active infection of the residual limb.
• * Active smoker during the study
• * We will also exclude those who are on chronic immunosuppressive therapies such as oral steroids, but also those on chronic topical steroids in the area of investigation.
• * Recent amputee who has not yet been approved to use a prosthetic.
• * Use of a prosthetic for less than 3 months.
• * Amputees with neuromas of the terminal limb within the last 3 months.
• * Known bleeding disorder.
• * For those receiving Bellafill/collagen skin test: history of serious allergy, such as anaphylaxis.
• * For whole stump injections: Have a history of congenital or idiopathic methemoglobinemia, glucose-6-phosphate deficiencies, or use of medications associated with drug-induced methemoglobinemia. (specifically: Sulfonamides, Acetaminophen, Acetanilid, Aniline dyes, Benzocaine, Chloroquine, Dapsone, Naphthalene, Nitrates and Nitrites, Nitrofurantoin, Nitroglycerin, Nitroprusside, Pamaquine, Para-aminosalicylic acid, Phenacetin, Phenobarbital, Phenytoin, Primaquine, or Quinine.)