TEACH: Kidney Transplant - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if the MSCs, along with medication, can allow a kidney transplant patient to slowly reduce and/or completely stop all anti-rejection drugs.
What is the Condition Being Studied?
Kidney Transplant

Who Can Participate in the Study?

Adults needing a kidney transplant that have not:
- Had Immunosuppressive drug therapy in the past year
- Had congestive heart failure
- Had pulmonary edema

Age Group
Adults

What is Involved?

If you choose to join this study as a donor you will:
- Have a physical exam
- Have blood Draws
- Give a fecal sample
- Have bone marrow taken out of the back of your pelvic bone with a needle after your kidney is taken out
- Complete a follow-up visit 1-3 weeks after the surgery

If you choose to join this study as a recipient you will:
- Have a kidney biopsy done
- Have blood draws
- Have surgery to get the donor kidney
- Complete follow-up visits every 2 weeks after surgery
- Starting week 6 receive Mesenchymal Stromal Cell (MSC) infusions and continue every 4 weeks for a year

Study Details

Full Title
Donor-derived Mesenchymal Stromal Cells, Alemtuzumab, Co-stimulation Blockade and Sirolimus for Tolerance Induction in Adult Kidney Allograft Recipients
Principal Investigator
Kidney/Pancreas Transplant Surgeon
Protocol Number
IRB: PRO00083359
NCT: NCT03504241
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698