PROTOCOL Phase 1/2 Clinical Study Evaluating the Safety and E??icacy ofFresh Frozen Plasma from young healthy donors ages 18 to 35, who have received Granulocyte-Colony Stimulating Factor to Ameliorate Frailty and Enhance the Immune Risk Pro?le in Older :J-eH-sn Individuals Self-Funded Young Blood Clinical Trial FAQS for Donors . What is the Clinical Trial? The trial will use fresh frozen plasma from healthy, young donors to ameliorate frailty and enhance the immune risk pro?le in older individuals. . Who can be a donor - What is the quali?cation process? There are several criteria that have to be met by the donor. The main ones are: 0 Be aged between 18 and 35 0 Minimum weight of 1501bs 0 Complete the Full Length Universal Donor History Questionnaire . Why should I be a donor? You will be aiding in ?nding a treatment to reduce the frailty in the older generations, increasing the quality of lives! Where can the Full Length Universal Donor History Questionnaire be found? The questionnaire can be found online but you will ?ll out the questionnaire when you come in for screening. How many donors are you looking for? 60 to 100 How many participants will there be? 30 How long will the study run? 3 years 8. What will I have to do to be approved as a donor? You will have to ?ll out the Full Length Universal Donor History Questionnaire and have a blood test. PROTOCOL Phase 1/2 Clinical Study Evaluating the Safety and E?cacy ofFresh Frozen Plasma from young healthy donors ages 18 to 35, who have received Granulocyte-Colony Stimulating Factor to Ameliorate Frailty and Enhance the Immune Risk Pro?le in Older Individuals 9. Why do I have to take a blood test? 0 Blood testing is done to determine your blood type. It?s also done to check for any infectious diseases that could be transmitted through the blood to the participant. 10. What?s the next step after being approved as a donor? 0 A Medical examination is done the day prior to the start of medication. The injections and medical checks will then occur daily for a week. 11. What medication will you be giving me? 0 Granulocyte Colony Stimulating Factor (G-CSF). This is a naturally occurring protein that has little side-effects. 12. How will the medication be given? 0 The G-CSF is administered by sub-cutaneous injection. 13. What is the purpose of taking G-CSF boosts the immune system causing the stem cells in the blood to increase. 14. How long will my involvement be? I From screening to ?nal collection, approximately a week and a half. However, you have to be available for follow up contacts for 3 years. 15. What will the process look like? 0 The schedule is as follows: 0 Prior to Day 1 Two Screenings Day 1 Medical Check and tests. injection. Day 2 Medical Check and tests. 2nd injection. Day 3 Medical Check and tests. 311d injection, possible collection. Day 4 Medical Check and tests. 4??1 injection, possible collection. Day 5 Medical Check and tests. 5"?1 injection, possible collection. Day 6 Medical Check and tests. 6rld injection, possible collection. Day 7 Medical Check and tests. Possible collection. PROTOCOL Phase 1/2 Clinical Study Evaluating the Safety and E?icacy ofFresh Frozen Plasma from young healthy donors ages 18 to 35, who have received Granulocyte-Colony Stimulating Factor to Ameliorate Frailty and Enhance the Immune Risk Pro?le in Older Individuals 16. How long will each visit take? 0 This depends on whether a collection is occurring on that day or not. 0 If collection is occurring: 3-5 hours 0 If there?s no collection: around 20 minutes 17. Will there be any follow-up visits? I Yes. There will be 7 follow ups: 2 days after second apheresis procedure (in person) 1 week (in person or phone call) 1 month (in person or phone call) 6 months (in person or phone call) 1 year (in person) 00000 2 years (in person) 0 3 years (in person) 18. What exactly will I be donating? 0 Plasma and peripheral stem cells will be collected through an apheresis procedure. 19. Who will receive my plasma? I We will match you to a participant based on your blood type. 20. How does the apheresis procedure take place? 0 Apheresis is a medical procedure that involves removing whole blood from a donor or patient and separating the blood into individual components so that one particular component can be removed. PROTOCOL Phase 1/2 Clinical Study Evaluating the Safety and E?icacy ofFresh Frozen Plasma from young healthy donors ages 18 to 35, who have received Granulocyte-Colony Stimulating Factor to Ameliorate Frailty and Enhance the Immune Risk Profile in Older Individuals 21. How many apheresis procedures are done? i There will be two apheresis procedures done in the span of a week. The procedures will be done two days apart. 22. Will there be any cost to me? I Neither you nor your insurance company will be billed for any costs associated with this study. 23. Will I be compensated? 0 Yes you will be given up to $750. 24. How will this payment be made? 0 You will be compensated on a daily basis: 0 $25 for each of two screenings 0 $100 per day thereafter up to 7 days 25. Can I have copies of my tests? a You are welcome to any and all copies of your laboratory tests following completion of the trial. However, until the trial is completed, the information is part of an ongoing FDA clinical trial and cannot be released. PROTOCOL Phase 1/2 Clinical Study Evaluating the Safety and E?icacy ofFresh Frozen Plasma from young healthy donors ages 18 to 35, who have received Granulocyte-Colony Stimulating Factor (G-CSF) to Ameliorate Frailty and Enhance the Immune Risk Pro?le in Older Individuals 26. What are the possible side-effects? 0 G-CSF can result in some mild to moderate pain, primarily over the lower back or sternum. This can be relieved with medications such as Tylenol. G- CSF is Widely used in a variety of settings and one-time use for granulocyte mobilization is considered highly safe. During Apheresis, although rare, some donors may experience chills, shakes, numbness and tingling of the hands and feet, lightheadedness or, rarely, fainting. These reactions are reversible by replacing calcium by pills or injections. Some donors may experience a moderate decrease in the platelet count. More severe side-effects in healthy donors are not completely impossible. A registered nurse will be in constant attendance and a physician will be readily available if needed. 27. What are the possible benefits? 0 It cannot be promised that you will receive any medical bene?ts from being in this study. The results of this study may help people with frailty in the future. 28. Is it possible to make my plasma donation at a facility near Where I live? I Unfortunately, the study can only be conducted out of the Institute in Boynton Beach, Florida. 29. What happens if I need to drop out, either due to side-effects or something else? 0 You can leave the study at any time. Your decision will not cause any penalty or loss of bene?ts to which you are entitled. You may still be asked to have some of the end of study procedures done.