title: A randomized pilot study of donor stem cell infusion in living-related kidney transplant recipients receiving alemtuzumab.
abstract: BACKGROUND
  Transplant tolerance would remove the need for maintenance immunosuppression while improving survival and quality of life.
  
  
  METHODS
  A prospective, randomized pilot study was undertaken to assess the safety and efficacy of donor stem cell infusion (DSCI) in living-related kidney transplant recipients treated with alemtuzumab (C1H) induction and tacrolimus and mycophenolate maintenance with switch to sirolimus and weaning over 2 years.
  
  
  RESULTS
  Four patients received DSCI; five patients were controls. Graft failure occurred in two patients in the DSCI arm. Recurrence of glomerular disease occurred in two DSCI recipients, leading to graft loss in one. Biopsy-proven acute rejection episodes occurred in three patients (two in the DSCI vs. one in the control). One DSCI patient, with recurrence, subsequently developed antibody-mediated rejection leading to graft failure. In the remaining two DSCI patients, weaning was attempted but was not successful. All (4 of 4) DSCI patients had biopsy-proven chronic allograft injury and/or recurrence.
  
  
  CONCLUSIONS
  DSCI with C1H induction and a steroid-free maintenance regimen in a small group of patients failed to induce tolerance, with suboptimal patient and graft survival. The results do not justify extension of this particular trial and underscore the importance of patient selection, specifically avoidance of patients with glomerulopathies whose recurrence may obscure potential benefit.
authors.affiliation: 1 The Lillian Jean Kaplan Renal Transplant Center of the Division of Transplantation, Department of Surgery, University of Miami Leonard M. Miller School of Medicine, Miami, FL. 2 Division of Nephrology and Hypertension, Department of Medicine, University of Miami Leonard M. Miller School of Medicine, Miami, FL. 3 Diabetes Research Institute, University of Miami Leonard M. Miller School of Medicine, Miami, FL. 4 Address correspondence to: Dr. Gaetano Ciancio, 1801 NW 9th Avenue, Miami, FL 33136.
authors.forename: Gaetano
authors.initials: G
authors.lastname: Ciancio
authors.forename: Junichiro
authors.initials: J
authors.lastname: Sageshima
authors.forename: Edip
authors.initials: E
authors.lastname: Akpinar
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Gaynor
authors.forename: Linda
authors.initials: L
authors.lastname: Chen
authors.forename: Alberto
authors.initials: A
authors.lastname: Zarak
authors.forename: Lois
authors.initials: L
authors.lastname: Hanson
authors.forename: Lissett
authors.initials: L
authors.lastname: Tueros
authors.forename: Giselle
authors.initials: G
authors.lastname: Guerra
authors.forename: Adela
authors.initials: A
authors.lastname: Mattiazzi
authors.forename: Warren
authors.initials: W
authors.lastname: Kupin
authors.forename: David
authors.initials: D
authors.lastname: Roth
authors.forename: Camillo
authors.initials: C
authors.lastname: Ricordi
authors.forename: George W
authors.initials: GW
authors.lastname: Burke
mesh_terms: D000328:Adult; D000074323:Alemtuzumab; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D057915:Drug Substitution; D005190:Family; D005260:Female; D005431:Florida; D006084:Graft Rejection / Q000276:immunology / Q000517:prevention & control; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation; D019520:Living Donors; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D010865:Pilot Projects; D011446:Prospective Studies; D012008:Recurrence; D020123:Sirolimus / Q000627:therapeutic use; D033581:Stem Cell Transplantation; D016559:Tacrolimus / Q000627:therapeutic use; D013997:Time Factors; D023001:Transplantation Tolerance / Q000187:drug effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; D000074323:Alemtuzumab; D009173:Mycophenolic Acid; D020123:Sirolimus; D016559:Tacrolimus
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