- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00696046
Intra Bone Marrow Injection Of Unrelated Cord Blood Cells (CB01)
Direct Intra Bone Marrow Injection Of Unrelated Cord Blood Cells To Improve Engraftment And Reduce Acute Graft-Versus-Host Disease
Study Overview
Status
Conditions
Intervention / Treatment
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 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
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Genoa, Italy, 16132
- Recruiting
- A.O. San Martino - Dep. Center Stem cells and cell therapy"
-
Principal Investigator:
- francesco frassoni, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the safety and the probability of neutrophils and platelets recovery after i.b. cord blood transplant.
Time Frame: Full blood count, Monitoring Infections post Transplant, Bone marrow evaluation, Chimerism Analysis, Haematopoietic Reconstitution
|
Full blood count, Monitoring Infections post Transplant, Bone marrow evaluation, Chimerism Analysis, Haematopoietic Reconstitution
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the incidence/severity of acute Graft-versus-Host Disease, relapse and overall survival.
Time Frame: Graft-versus-host disease was scored according to current criteria (13).
|
Graft-versus-host disease was scored according to current criteria (13).
|
Collaborators and Investigators
Investigators
- Principal Investigator: francesco frassoni, MD, A.O. San martino
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CB01-139
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hematologic Diseases
-
St. Jude Children's Research HospitalRecruitingRefractory Hematologic Malignancy | Relapsed Hematologic MalignancyUnited States
-
Epizyme, Inc.WithdrawnRefractory Hematologic Malignancy | Relapsed Hematologic MalignancyUnited States
-
University of Colorado, DenverNot yet recruitingHematologic Malignancy | Pediatric Patients | Other Hematologic ConditionUnited States
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Not yet recruitingHematologic MalignancyChina
-
Innovent Biologics (Suzhou) Co. Ltd.Recruiting
-
Massachusetts General HospitalRecruiting
-
Fondazione EMN Italy OnlusCompletedHEMATOLOGIC MALIGNANCIESItaly
-
Center for International Blood and Marrow Transplant...National Cancer Institute (NCI); National Heart, Lung, and Blood Institute... and other collaboratorsCompletedHematologic MalignancyUnited States
-
Rigshospitalet, DenmarkNovo Nordisk A/SCompletedHematologic MalignancyDenmark
-
SecuraBioCompletedHematologic MalignancyUnited States, Italy
Clinical Trials on Intrabone Marrow Injection
-
Università degli Studi di BresciaUnknown
-
Maria Sklodowska-Curie National Research Institute...Unknown
-
Ospedale Santa Croce-Carle CuneoUnknownAdvanced Haematological Malignancies | High Risk Haematological MalignanciesItaly
-
Clinical Center of Cellular Technologies, RussiaSamara State Medical University; Regional hospital of SamaraCompletedLower Extremity Ischemia
-
Hospital Clinic of BarcelonaUnknown
-
Chinese PLA General HospitalUnknownLeft Ventricular Dysfunction | Chronic Myocardial Ischemia | Old Myocardial InfarctionChina
-
Henrique Bittencourt, MD, PhDMichel Duval, MD; Pierre Teira, MD; Sonia Cellot, MD, PhD; Isabelle Louis, PhD; Elie... and other collaboratorsCompletedHematopoietic Stem Cell TransplantationCanada
-
Man Clinic for Andrology, Male Infertility and...Unknown
-
Regenerative Pain Center, IllinoisCompletedHip and Knee OsteoarthritisUnited States
-
University of OuluCompleted