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Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies

NCT01613066 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2012-06-06

No results posted yet for this study

Summary

Cord blood (CB) from an unrelated donor is increasingly used an alternative source of hematopoietic stem cells for adults with hematologic malignancies who lack an HLA-matched donor. However, the utilization of single-unit CB for transplantation of adult patients has been impeded by the low number of nucleated cells available from individual CB units. Direct intrabone CB injection (IBCBi) has been recently investigated as a solution to cell dose problem in adults, with the aims of minimizing non-specific loss of progenitors. We set up a phase I-II study to assess the safety and efficacy of CB transplantation by IBCBi in adult patients with advanced or high-risk hematological malignancies

Conditions

  • High Risk Haematological Malignancies
  • Advanced Haematological Malignancies

Interventions

PROCEDURE

Intrabone Allogeneic Transplant

Unrelated single unit intrabone cord blood transplantation

Sponsors & Collaborators

  • Ospedale Santa Croce-Carle Cuneo

    lead OTHER

Principal Investigators

  • Daniele Mattei, MD · ASO S Croce e Carle

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2012-11-30
Completion
2013-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01613066 on ClinicalTrials.gov