Autologous Volar Fibroblast Injection Into the Stump Site of Amputees

Patients interested in study participation must meet all of the following inclusion criteria:

• May be male or female
• Must be between 18 years and 65 years of age
• Must have a below the knee amputation.
• Must be using a prosthetic for the vicinity of 3 months or have had osteo-integration of a prosthetic in place for 1 month.
• In the opinion of the investigator, must be medically able to undergo the administration of study material determined by laboratory tests obtained within 7 days before baseline for which the investigator identified no clinically significant abnormality.
• Be able to comprehend the informed consent document and provide consent for participation

• Females of childbearing potential must:

  • have a negative pregnancy test at screening
  • agree to not become pregnant or breastfeed for the period of the study through 1 month after completion of the study
  • be willing to use a reliable form of contraception during the study
• Be willing and able to comply with the scheduled visits, biopsy/injection procedures, wound care instructions treatment plan, and other study procedures for the duration of the study.

Exclusion Criteria:

Patients meeting any of the following criteria will be ineligible for study participation:

• 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.)