Intra-Osseous Co-Transplant of UCB and hMSC | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02181478

Intra-Osseous Co-Transplant of UCB and hMSC
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

This clinical trial studies intra-osseous donor umbilical cord blood and mesenchymal stromal cell co-transplant in treating patients with hematologic malignancies. Giving low doses of chemotherapy and total-body irradiation before a co-transplant of donor umbilical cord blood and mesenchymal stromal cells into the bone (intra-osseous) helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil at the time of transplant may stop this from happening.

Status: 
Recruiting
Study Date: 
Wed, 07/01/2015 to Wed, 03/01/2017
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Intervention: 
Drug: cyclophosphamide All patients will receive a single IV dose of 50 mg/kg of cyclophosphamide on day -6 Other Names: CPM CTX Cytoxan Endoxan Endoxana Drug: fludarabine phosphate Given by IV during prep at 40mg/m2 for 5 days Other Names: 2-F-ara-AMP Beneflur Fludara Radiation: total-body irradiation Undergo single fraction of reduced intensity conditioning (RIC) regimen of 200 cGy TBI without shielding on day -1 Other Name: TBI Drug: cyclosporine Initiated in patients on the day -5. Cyclosporine will be administered orally or intravenously at 2 mg/kg/dose every 12 hours for 2-hour period. Cyclosporine will continue until day +100 Other Names: ciclosporin cyclosporin cyclosporin A CYSP Sandimmune Drug: mycophenolate mofetil Given at 1g intravenously or orally twice daily from day -5 to +100, or as clinically indicated. Other Names: Cellcept MMF Procedure: umbilical cord blood transplantation Following RIC, on day T+0, dimethylsulphoxide will be removed from the cord blood cells and given as transplant. Other Names: cord blood transplantation transplantation, umbilical cord blood UCB transplantation Procedure: mesenchymal stem cell transplantation The total dosage of hMSC will be 2x10^6cells/kg (+/-20%). Other Name: hMSC transplantation