Using Donor Stem Cells and Alemtuzumab to Prevent Organ Rejection in Kidney Transplant Patients

Phase 1/2 Completed 9 enrolled University of Miami Immune Tolerance Network (ITN) · collab

RandomizedParallel-groupSingle-blindTreatment

Summary

Alemtuzumab is a man-made antibody used to treat certain blood disorders. This study will evaluate treatment of kidney transplant recipients with alemtuzumab and other immune system suppressing medications with or without infusions of bone marrow stem cells from the kidney donor. The purpose of this study is to find out which strategy is more effective in preventing organ rejection and maintaining patient health.

Timeline

Start: 2004-09
Primary completion: 2009-11
Completion: 2009-11

Publications

Ciancio G, Sageshima J, Akpinar E, Gaynor JJ, Chen L, Zarak A, Hanson L, Tueros L, Guerra G, Mattiazzi A, Kupin W, Roth D, Ricordi C, Burke GW 3rd. A randomized pilot study of donor stem cell infusion in living-related kidney transplant recipients receiving alemtuzumab. Transplantation. 2013 Nov 15;96(9):800-6. doi: 10.1097/TP.0b013e3182a0f68c.

Drugs

Evaluation	Drug	Modality	Dose	Route
Background	Alemtuzumab	Monoclonal antibody	—	Intravenous
Background	Mycophenolate Mofetil	Small molecule	—	Oral
Background	Sirolimus	Small molecule	—	Oral
Background	Tacrolimus	Small molecule	—	—

Using Donor Stem Cells and Alemtuzumab to Prevent Organ Rejection in Kidney Transplant Patients

Summary

Timeline

Publications

Drugs

Indications