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Transplantation of Ex-vivo Expanded Cord Blood Stems Cells

2014-08-27 03:17:12 | BioPortfolio

Summary

This program offers the opportunity to receive an allogeneic transplant to try to control the malignant hematologic in the absence of acceptable conventional donor and with a risk-benefit ratio equivalent to that which would be expected with a transplant from a more conventional donor.

An economy of means in that this method could serve as an alternative to 2 units of placental blood transplantation. The current cost of disposal of a unit of placental blood from a bank is approximately 22000 € (Source: Biomedicine Agency, 2007 rates). The amplification process as controlled by "EFSAL" is 12000 €. Therefore, buying a unit and ex-vivo amplification is more economical. Moreover, the availability of placental blood is not infinite, and the use of one unit per patient will also save resources that can be valuable for certain groups of patients.

In the longer term, methods of amplification of specific immunocompetent cells (from the fraction of CD 34 neg cells) are already being evaluated in the laboratory. They allow to consider a faster recovery, better and more targeted, including cells against the disease for which transplantation is performed.

Description

This is a multicenter prospective non randomized phase 2 clinical trial.

The primary objective is defined by getting a neutrophil count above 500/ml for 3 consecutive days at day 42 after transplantation, in association with complete or partial chimerism on T cells (10 % to 90%).

The secondary objectives are:

- the feasibility of expansion,

- tolerance immediate injection of a graft amplified,

- the payback of a platelet count> 20 000/microlitre without transfusion,

- Incidence of graft loss or rejection within 6 months following transplantation,

- the incidence of acute and chronic GVHD,

- the mortality rate associated with transplantation,

- the incidence of relapse of hematologic malignancies,

- Overall survival,

- Disease-free survival at 1 year post transplant.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Malignant Haematological Disease

Intervention

allogeneic transplant

Location

Service d'hématologie et d'Oncologie Clinique - Hôpital Lapeyronie - 371 avenue du Doyen Gaston GIRAUD
Montpellier
France
34295

Status

Not yet recruiting

Source

University Hospital, Bordeaux

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:12-0400

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Medical and Biotech [MESH] Definitions

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The treatment of patients without the use of allogeneic BLOOD TRANSFUSIONS or blood products.

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