Treatment with Laviv (Azficel-T)

Treatment with LaViv™ (azficel-T)

The information in this document is meant to help you decide whether or not to undergo treatment with LAVIV™. Please feel free to ask if you have any questions or concerns about this treatment option. You have the right to be informed about your treatment so that you may make a decision to undergo the procedure, knowing the risks and uncertainties involved. My provider has explained to me the details of the biopsy and the LAVIV™ treatment procedure including the alternatives, risks and potential benefits. I have had an opportunity to ask questions. I am advised that, though good results are expected, they are not guaranteed; nor can there be any guarantees against unwanted results or side effects.

I understand that in the first two to three days following treatment with LAVIV™, I may experience bleeding, lump formation at the site of the injection, swelling, redness, pain, itching or irritation, and bruising. These symptoms typically resolve within a few days, but may take up to one week to resolve. I have been informed that the practice of medicine is not an exact science and that no guarantees can be or have been made concerning the expected results in my case. I accept responsibility for any complications that may occur and thereby absolve Robert Strimling, MD and / or any associated person of any blame resulting there from.

Treatment: I understand that my physician will initiate the LAVIVV™ process by taking a small skin sample (biopsy) from behind my ear. My sample will then be sent to a Fibrocell Science laboratory where the cells will be expanded under sterile conditions to create LAVIV™ for re-introduction into my skin or stored cryogenically (frozen). I understand that this is a biologic process and a definite time frame for cell growth cannot be predicted, but that every effort will be made to have my LAVIV™ ready to ship within 90 days of my skin sample arriving at Fibrocell Science. Serious allergic reactions can occur in patients with a known hypersensitivity (allergy) to gentamicin, amphotericin, dimethyl sulfoxide (DMSO) or material of bovine (cattle) origin. Patients taking aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) or anticoagulants or who have a bleeding disorder, have a greater risk of severe bleeding or bruising. Patients with a history of skin cancer, keloids, scarring or immune problems should not use LAVIV™. In very few cases, (less than 6%) a patient’s cells may not demonstrate sufficient growth characteristics. In this event, Fibrocell Science may require that a second biopsy sample be sent to the laboratory in order to be able to grow sufficient cells for re-introduction into my skin.

Unused Material: I understand that any cells and any of the by-products of the cell treatment process not shipped to my physician remains the sole property of Fibrocell Science. I can access my cells only through my physician for future treatments at additional cost. I understand that unforeseen occurrences such as natural disasters could result in the loss of one or all of the stored cells. Fibrocell Science and its staff cannot guarantee against all possible factors that might result in the loss of the cells, and therefore, I agree to hold harmless my physician, Fibrocell Science, its employees, consultants, predecessors, successors, directors, and/or owners under such circumstances. Patient Consent: I have read the information in this form (or it has been read to me). I was free to ask any questions and they have been answered. I am over 18 years of age and, exercising my free power of choice, hereby give my consent to undergo treatment with LAVIV. 1) I have read and understood this consent form and the information provided to me. 2) I have had the consent document explained to me. 3) I understand the risk of biopsy and the possibility that my cells will not produce enough viable cells to manufacture sufficient quantity of LAVIV™ for injection, and that in such an event I will be offered the opportunity to repeat the procedure once, without an additional fee. 4) I have been informed of the methods, nature, and schedule of this procedure. I understand that the effects of LAVIV™ are not immediate, but may appear over the course of the three-treatment regimen. 5) I have informed my physician of any history of skin cancer, keloids, scarring or immune problems. 6) I have spoken directly with the physician who will be performing this procedure and all my questions concerning this process have been answered to my satisfaction and I have given my consent to proceed with this procedure. 7) I voluntarily agree to have a skin sample taken, my cell line expanded in a Fibrocell Science Laboratory and re-introduced into my skin via injection to treat areas discussed with my physician. 8) I have relinquished and/or assigned any rights to Fibrocell Science that I might have in any remaining cells or by-products. 9) I have received and signed a copy of this information and consent form. 10)

______Patient Name Patient Signature Date

______Witness Signature ______Date