Status:
UNKNOWN
Intra Bone Marrow Injection Of Unrelated Cord Blood Cells
Lead Sponsor:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Conditions:
Hematologic Diseases
Eligibility:
All Genders
16-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Compared to other stemcell sources cord blood (CB) is easier and safer to procure, has no donor attrition, a limitless supply, reduced viral transmission, less acute \& chronic GVHD, is rich in hemato...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Patients with hematologic malignancies and other forms of hematologic diseases including aplastic anemia
- 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.
- Age 16-70
- Serum creatinine \<1.5 mg/dL or Creatinine Clearance \>50 ml/min
- Serum bilirubin \<1.5 mg/dl, SGPT \<3 x upper limit of normal
- Negative serology for HIV
- Central Venous access (Central KT) secured through an indwelling catheter.
- Life expectancy is not severely limited by concomitant illness.
- Written and signed informed consent
Exclusion
- Acute Myocardial Infarction (AMI) within the last 12 months
- Positive pregnancy test
- Positive HIV serology
- Chronic renal insufficiency (Serum creatinine \>1.5 mg/dl or creatinine cleareance \<=50 ml/min)
- Patient has another progressive malignant disease or a history of other malignancies within 2 years prior to study entry.
- Severe psychiatric illness or any disorder that compromises ability to give truly informed consent for participation in this study.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00696046
Start Date
March 1 2006
End Date
June 1 2009
Last Update
June 12 2008
Active Locations (1)
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1
A.O. San Martino - Dep. Center Stem cells and cell therapy"
Genoa, genoa, Italy, 16132