The TEACH study has 5 phases as outlined in the table below. At the end of each phase of the study, you will be evaluated to see if you are eligible to move on. This will depend on how well you are doing and whether it is safe for you to move to the next phase. The total time you are in the study will depend on whether you move forward at each study phase or stop because it is not safe for you to move forward.
Your visit schedule will therefore depend on the phase of the study and how well you are doing. In total, participation may last between 5 and 7 years.
|Phase||# of Study Visits||How Long Phase Lasts|
In this phase prior to transplant, you will undergo screening to determine whether you are eligible for the study
|1||Up to 4 weeks|
|Kidney transplant||1||1 day|
|In this phase, you will be taking anti-rejection medications and getting MSC treatments after transplant||16 - 28||1 to 2 years, after transplant|
|In this phase, you will gradually decrease your anti-rejections medications and then stop taking them||9 - 13||36 to 64 weeks, after final dose of MSCs|
|In this phase, you will undergo follow-up after you have stopped taking your anti-rejection medications||12||2 years, after final dose of anti-rejection medications|
Study participants must come to Duke University Hospital for certain visits; other visits can be done over the phone and by visiting your local laboratory. During your study visits, you will generally get a brief physical exam, a review of your health and current medications, and clinical blood tests. Research samples will also be collected at some visits.