Study Results
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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UNKNOWN
NA
5 participants
INTERVENTIONAL
2016-06-30
2018-12-31
Brief Summary
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The investigator team involved in this trial has recently reported the first such case of CCR5 delta32/delta32 CB transplantation in a patient with HIV infection, showing a reduction of the patient's latent viral reservoir and, upon achievement of full CB chimerism, resistance of his CD4 T-lymphocytes to infection by HIV. This proof of concept led the Spanish National Transplant Organization (ONT) to generate an inventory of over 150 CCR5 Δ32/Δ32 CB units readily available for transplant.
From this initial evidence and repository of CB units, financial support from the Fundación Mutua Madrileña (FMM) has allowed the investigators to launch this first pilot clinical trial in this indication. The study was launched in January 2016 at Hospital Universitario Puerta de Hierro Majadahonda. All HIV virology and reservoir analyses are carried out by the AIDS Immunopathology Unit at the Spanish Instituto de Salud Carlos III. Three additional transplant centres in Spain will also shortly open the trial.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Study treatment
Allogeneic transplantation with CCR5 delta32/delta32 hematopoietic cells from cord blood.
CCR5 delta32/delta32 cord blood transplantation
Interventions
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CCR5 delta32/delta32 cord blood transplantation
Eligibility Criteria
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Inclusion Criteria
* HIV infection.
* Hematologic malignancies or any other condition with a standard indication for allogeneic hematopoietic cell transplantation. See indications by the European Society for Blood and Marrow Transplantation (EBMT). \[Sureda A. et al. Indications for allo- and auto-SCT for haematological diseases, solid tumours and immune disorders: current practice in Europe, 2015. Bone Marrow Transplantation (2015) 50, 1037-1056.\]
* Lack of HLA-identical related donor
* Availability of at least one cord blood unit CCR5 delta32 homozygous that meets quality standards.
Exclusion Criteria
* Contraindication for allogeneic stem cell transplantation.
18 Years
65 Years
ALL
No
Sponsors
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Fundación Mutua Madrileña
OTHER
Instituto de Salud Carlos III
OTHER_GOV
Puerta de Hierro University Hospital
OTHER
Responsible Party
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Rafael F. Duarte
Head of the Hematopietic Cell Transplantation program
Principal Investigators
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Rafael Duarte Palomino
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Puerta de Hierro- Majadahonda
Locations
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Hospital Universitario Puerta de Hierro- Majadahonda
Majadahonda, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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María Esther Martínez Muñoz
Role: primary
Isabel Salcedo
Role: backup
Other Identifiers
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HIVECT-1501
Identifier Type: -
Identifier Source: org_study_id