Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2013-05-31

Brief Summary

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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

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Detailed Description

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Conditions

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High Risk Haematological Malignancies Advanced Haematological Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Patients with high risk haematological malignancies

Group Type EXPERIMENTAL

Intrabone Allogeneic Transplant

Intervention Type PROCEDURE

Unrelated single unit intrabone cord blood transplantation

Interventions

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Intrabone Allogeneic Transplant

Unrelated single unit intrabone cord blood transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Advanced or High Risk Haematological Malignancies
* Age 18-65 years
* no suitable unrelated HLA-matched donors identified in a clinically useful time-frame
* Informed consent

Exclusion Criteria

* Active infectious disease at inclusion
* HIV- positivity or active hepatitis infection
* Impaired liver function (Bilirubin \> upper normal limit; Transaminases \> 3.0 x upper normal limit) at inclusion
* Impaired renal function (Creatinine-clearance \<60 ml/min; Serum Creatinine \>1.5 x upper normal limit) at inclusion
* Psychiatric diseases or conditions that might impair the ability to give informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No