A Single-arm Safety Study of Transplantation Using Umbilical Cord Blood and Human Placental-derived Stem Cells From Partially Matched Related Donors in Persons With Certain Malignant Blood Diseases and Non-malignant Disorders
- Conditions
- Hematologic Malignancies
- Interventions
- Procedure: UCB and HPDSC
- Registration Number
- NCT00596999
- Lead Sponsor
- Celgene Corporation
- Brief Summary
To investigate the safety of partially matched related human placental-derived stem cells (HPDSC) administered in conjunction with umbilical cord blood (UCB) stem cells from the same donor in subjects with various malignant or nonmalignant disorders potentially curable with stem cell transplantation and to assess potential restoration of normal hematopoiesis and immune function in subjects with these disorders
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- suitable UCB collected from partially or fully HLA matched related donor
- subject requires umbilical cord transplantation
Exclusion Criteria
- any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- major anticipated illness or organ failure incompatible with survival from stem cell transplant
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 UCB and HPDSC all subjects will be treated with UCB and HPDSC
- Primary Outcome Measures
Name Time Method Incidence of GVHD, time to engraftment and survival 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Louisiana State University Children's Hospital
🇺🇸New Orleans, Louisiana, United States