Suspended

CB01Direct Intra Bone Marrow Injection Of Unrelated Cord Blood Cells To Improve Engraftment And Reduce Acute Graft-Versus-Host Disease

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What is being tested

Data Collection

Who is being recruted

Hematologic Diseases

+ Hemic and Lymphatic Diseases

From 16 to 70 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: March 2006
See protocol details

Summary

Principal SponsorIRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Study Contactfrancesco Frassoni, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2006

Actual date on which the first participant was enrolled.

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

Official TitleDirect Intra Bone Marrow Injection Of Unrelated Cord Blood Cells To Improve Engraftment And Reduce Acute Graft-Versus-Host Disease
NCT00696046
Principal SponsorIRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Study Contactfrancesco Frassoni, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

47 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 16 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hematologic DiseasesHemic and Lymphatic Diseases

Criteria

9 inclusion criteria required to participate
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
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6 exclusion criteria prevent from participating
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)
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

A.O. San Martino - Dep. Center Stem cells and cell therapy"

Genoa, ItalyOpen A.O. San Martino - Dep. Center Stem cells and cell therapy" in Google Maps
SuspendedOne Study Center