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Home > "S" Clinical Trials Conditions > Sibling Donor Cord Blood Banking and Transplantation  Sibling Donor Cord Blood Banking and Transplantation
Sibling Donor Cord Blood Banking and Transplantation
For Condition: Bone Marrow Transplantation,Anemia (Cooley's),Blood Disease,Leukemia,Hematopoietic Stem Cell Transplantation,Anemia, Sickle Cell
Status: Not yet recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To develop a national cord blood bank for siblings of patients with hemoglobinopathies, thalassemia and potentially malignant diseases.
Details: BACKGROUND: During the past decade, a number of advances have been made in the treatment or patients sickle cell anemia and thalassemia. Among these is allogeneic bone marrow transplantation, the only current treatment that offers the potential for cure. In sickle cell anemia, transplantation has been performed in patients who have had advanced organ damage while in thalassemia, transplantation has been performed before evidence of iron related tissue damage. Due to concerns over engraftment and graft versus host disease (GVHD), transplants for patients with hemoglobinopathies have been limited to situations where an HLA compatible donor exists. Unfortunately, an HLA matched related donor is often not available. Umbilical cord blood, a recently recognized source of hematopoietic stem cells, has been used to successfully transplant over 500 patients. The potential advantages of cord blood over other donor sources of stem cells is related to the observation that even without complete HLA compatibility, the risk of high-grade GVHD is minimal. DESIGN NARRATIVE: The study will establish a national Sibling Donor Cord Blood (SDCB) Program, evaluate its use in a multi-center pilot study of transplantation, and develop a Web-based data management system to support these two projects. A multi-center pilot study will be conducted on cord blood transplantation in children with sickle cell disease or thalassemia. The investigators will test the hypothesis that a novel immunosuppressive conditioning regimen (fludarabine, cyclophosphamide and busulfan) and post transplant therapy (mycophenalate mofetil and cyclosporine) will improve engraftment rates and prevent disease recurrence. The effect of SDCB transplantation on hematologic parameters and GVHD will be monitored. Information for this pilot study will be used to design new approaches employing SDCB transplantation for patients with hemoglobinopathies.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BertramLubin, , Children's Hospital, Oakland
Additional Information:
Study ID Numbers: 141;
Study Start Date: January 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00029380
Other Hematopoietic Stem Cell Transplantation Studies:
1. Treatment for Chronic Pain in Patients With Advanced Cancer
2. Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
3. Pharmacokinetic study of palifermin in subjects receiving radiation therapy and chemotherapy followed by blood stem cell support
4. Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer
5. Physician-Initiated Stop-Smoking Program for Patients Receiving Treatment for Early-Stage Cancer
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Sibling Donor Cord Blood Banking and Transplantation
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