If you are interested in participating in this study, and there is a participating hospital in your area, you will first be asked to sign a consent form. You will then be examined in the hospital to check if you fulfil all criteria for participation in the study.
If you are a suitable candidate to participate in the study, you will be asked to come to the hospital for bone marrow extraction. Bone marrow will be taken with a syringe and needle from several locations from the pelvic bone. The bone marrow sample will be shipped to a manufacturing facility to prepare the treatment product. After successful bone marrow collection, you will be assigned by chance (like drawing straws) to receive either REX-001 or the placebo.
About two days after bone marrow extraction, you will receive the REX-001 or placebo treatment as a one-time infusion in your leg. You will stay in the hospital for a minimum of 24 hours to monitor your well-being after the infusion.
After receiving the treatment, you will be asked to visit the hospital 8 times during a 2-year period to monitor your condition.