Direct Intra Bone Marrow Injection Of Unrelated Cord Blood Cells To Improve Engraftment And Reduce Acute Graft-Versus-Host Disease
16 Years
70 Years
Both
Hematologic Diseases
Trial Information
Direct Intra Bone Marrow Injection Of Unrelated Cord Blood Cells To Improve Engraftment And Reduce Acute Graft-Versus-Host Disease
Study Design Phase I-II study. Neutrophil recovery > 80% at day 60 and Platelets recovery >
80% at days 100 are defined as success. The limit of 60 days for neutrophil recovery was
chosen because it represents the time at which rescue with a second transplant is decided in
case of failure to engraft; the day 100 for platelets recovery is taken corresponds to first
form reported after transplant to the European Blood and Marrow Transplant Registry.
HLA-A and -B antigens will be identified by low resolution DNA typing, whereas HLA-DRB1 type
was determined by high resolution DNA typing techniques. HLA-A, HLA-B, and HLA-DRB1 typing
was used to select the most closely matched donor unit-recipient pair, with preference given
to HLA-DRB1-matched unit
Inclusion Criteria:
1. Patients with hematologic malignancies and other forms of hematologic diseases
including aplastic anemia
2. Patients will be eligible to enter the study when: A) an unrelated stem cell
transplantation was indicated; b) no suitable unrelated HLA-matched donors will be
identified in a clinically useful time-frame.
3. Age 16-70
4. Serum creatinine <1.5 mg/dL or Creatinine Clearance >50 ml/min
5. Serum bilirubin <1.5 mg/dl, SGPT <3 x upper limit of normal
6. Negative serology for HIV
7. Central Venous access (Central KT) secured through an indwelling catheter.
8. Life expectancy is not severely limited by concomitant illness.
9. Written and signed informed consent
Exclusion Criteria:
1. Acute Myocardial Infarction (AMI) within the last 12 months
2. Positive pregnancy test
3. Positive HIV serology
4. Chronic renal insufficiency (Serum creatinine >1.5 mg/dl or creatinine cleareance
<=50 ml/min)
5. Patient has another progressive malignant disease or a history of other malignancies
within 2 years prior to study entry.
6. Severe psychiatric illness or any disorder that compromises ability to give truly
informed consent for participation in this study.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
the safety and the probability of neutrophils and platelets recovery after i.b. cord blood transplant.
Outcome Time Frame:
Full blood count, Monitoring Infections post Transplant, Bone marrow evaluation, Chimerism Analysis, Haematopoietic Reconstitution
Safety Issue:
Yes
Principal Investigator
francesco frassoni, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
A.O. San martino
Authority:
Italy: Ethics Committee
Study ID:
CB01-139
NCT ID:
NCT00696046
Start Date:
March 2006
Completion Date:
June 2009
Related Keywords:
- Hematologic Diseases
- CORD BLOOD CELLS
- INTRA BONE MARROW INJECTION
- ENGRAFTMENT
- transplants
- Graft vs Host Disease
- Hematologic Diseases
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