Status:
TERMINATED
Intraosseous Infusion of Unrelated Cord Blood Grafts
Lead Sponsor:
Emory University
Conditions:
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
36-60 years
Phase:
NA
Brief Summary
In this trial the investigators seek to determine if injecting cord blood cells directly into the bone marrow (intraosseous injection), rather than infusing them intravenously, can improve engraftment...
Detailed Description
Hematopoietic (blood forming) stem cells (HSCs) reside primarily in the bone marrow. Traditionally, HSCs have been obtained directly from the bone marrow. Transplants using cells obtained this way are...
Eligibility Criteria
Inclusion
- Age 36 months to 60 years old (YO)
- No prior autologous or allogeneic transplant
- Karnofsky performance score or Lansky Play-Performance of at least 80
Exclusion
- Age \< 36 months or \> 60 YO
- creatinine clearance or nuclear medicine GFR of \< 50 mL/min
- cardiac ejection fraction \< 50%
- bilirubin \> 2 × upper limit of normal or ALT \> 4 × upper limit of normal or unresolved veno-occlusive disease
- Pulmonary carbon monoxide diffusing capacity (DLCO), adjusted for Hgb \< 50%
- Karnofsky performance score or Lansky Play-Performance Scale \<80
- Uncontrolled viral, bacterial, or fungal infection at the time of study enrollment
- Seropositive for HIV
- Availability of a willing and well HLA matched related (genotypically identical or mismatched at a single allele or antigen defined by typing at HLA A, B, C and DRB1 loci) donor
- Availability of a willing and well HLA matched unrelated (allele matched or mismatched at a single allele defined by allele level typing for HLA A, B, C and DRB1 loci) adult blood or marrow donor
- Availability of an umbilical cord blood unit, which provides at least a 4/6 HLA match as defined above and ≥ 5.0 \* 107 NC/Kg (cryopreserved)
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00967525
Start Date
March 1 2007
End Date
July 1 2011
Last Update
November 27 2013
Active Locations (2)
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1
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
2
Emory University
Atlanta, Georgia, United States, 30322