Autologous Hematopoietic Stem Cell Transplantation for Allogeneic Organ Transplant Tolerance

PHASE2CompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

April 30, 2020

Study Completion Date

April 30, 2020

Conditions
Complication of Transplanted Organ, Nos
Interventions
DRUG

Autologous Hematopoietic Stem Cell Transplant

"Step 1: Participants will receive intravenous chemotherapy and cytokine-based treatment for mobilization of hematopoietic stem cells (HSC) into the circulation, followed by collection using peripheral vein leukopheresis. The HSC graft product will undergo ex vivo purification with CD34 selection using Miltenyil CliniMACS and cryopreserved.~Step 2: Intravenous busulphan, cyclophosphamide and anti-thymocyte globulin will be administered to participants to achieve immune ablation prior to the infusion of the participants' own thawed HSC graft product (HSC transplant). Routine supportive measures will be employed during the recovery from the chemotherapy and HSCT. Participants' immune suppression will be stopped at the time of immunoablative therapy and will be switched to everolimus which will be discontinued at 6 months post HSCT."

Trial Locations (2)

K1H 8L6

The Ottawa Hopital, Ottawa

M5G 2N2

Multi-Organ Transplant Program, Toronto General Hospital, Toronto

Sponsors
All Listed Sponsors
collaborator

Ottawa Hospital Research Institute

OTHER

lead

Gary A Levy, O. Ont. MD. FRCP AGAF

OTHER