Natural Killer Index From Hematopoietic Stem Cell Graft

September 10, 2026 updated by: Nantes University Hospital

Pilot, Multicenter and Prospective Study of the Natural Killer Index From Hematopoietic Stem Cell Graft at a Genotypic, Phenotypic and Functional Level

Numerous studies about the potential role of NK alloreactive during a n hematopoietic stem cells graft are based on genotypical analyses of the KIR receptors and on genotypic incompatibilities between KIR and HLA for couple donor/recipient. There is still a lot of issues non resolved: Are KIR really expressed and how occur their expression during time when hematopoietic reconstitution? Is it depending on HLA of the recipient?If KIR are expressed, what are the mechanisms of alloreactivity of NK cells? Are NK able to lyse tumoral cells? Could alloreactive NK cells constitute a therapeutic tool able to induce tolerance and elimination of leukemia during hematopoietic stem cells grafts?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44093
        • CHU de Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age superior to 1 year
  • Patient that will be treated by an HSC graft
  • Initial pathology of recipient: acute lymphoblastic leukemia, acute myeloblastic leukemia, chronic myeloid leukemia

Exclusion Criteria:

  • Patient already included in a study with an exclusion period
  • HIV + or HCV + serology during pre-graft analysis
  • Patient already treated by an allograft of HSC

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: allogeneic donor from a file
Procedure: Blood test
The study of KIR and HLA genes will be performed on samples of cord blood or peripheral blood donor and recipient before transplant For grafts from placental cord blood, we do ask any additional samples.
Other: Registry geno-identical donor family
Procedure: Blood test
The study of KIR and HLA genes will be performed on samples of cord blood or peripheral blood donor and recipient before transplant For grafts from placental cord blood, we do ask any additional samples.
Other: transplantation of HSCs derived from placental blood
Procedure: Blood test
The study of KIR and HLA genes will be performed on samples of cord blood or peripheral blood donor and recipient before transplant For grafts from placental cord blood, we do ask any additional samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Estimate in the pilot study the percentage of different NK cell populations during hematopoietic reconstitution after HSCT with regard to the KIR and HLA genotypes of donor / recipient
Time Frame: J60 post-HSCT
J60 post-HSCT

Secondary Outcome Measures

Outcome Measure
Time Frame
Genetic analysis of KIR and HLA incompatibility of donor and recipient - Rate of in vitro amplification of NK cells from the donor - Assess the percentage of NK cells from the donor
Time Frame: J60 post-HSCT
J60 post-HSCT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Norbert Ifrah, MD, University Hospital, Angers
  • Principal Investigator: Patrice Chevallier, MD, Nantes University Hospital
  • Principal Investigator: Françoise Mechinaud, md, Nantes University Hospital
  • Principal Investigator: Nadège Corradini, MD, Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

February 15, 2007

First Submitted That Met QC Criteria

February 15, 2007

First Posted (Estimated)

February 16, 2007

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD/06/06-N
  • ID RCB 2007-A00002-51

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.

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