Mesenchymal Stem Cell Based Therapy for the Treatment of …

Verified March 2015 by Hospital de Cruces

Sponsor:

Collaborators:

Hospital Universitario Getafe

Hospital Infantil Universitario Nio Jess, Madrid, Spain

Information provided by (Responsible Party):

Clara I. Rodrguez, Hospital de Cruces

ClinicalTrials.gov Identifier:

NCT02172885

First received: June 12, 2014

Last updated: March 17, 2015

Last verified: March 2015

The purpose of this study is to determine the safety and effectiveness of two infusions of characterized HLA-identical MSC in non immunosuppressed children with Osteogenesis Imperfecta (OI).

Two Mesenchymal Stem Cell infusions

Mesenchymal Stem Cell Infusions

The principal aim of this trial is to assess the safety of non-mutated HLA-identical Mesenchymal stem cell (MSC) transplantation for OI pediatric patients irrespective of treatment with biphosphonates. Since MSC are inherently non-immunogenic and do not elicit proliferation of allogeneic lymphocytes (in co-culture experiments), a cell therapy based on HLA-identical or histocompatible (at least 5 shared out of 6 HLA antigens) allogenic MSC may be accomplished without subjecting the patients to immunosuppressor treatment. Adverse secondary effects due to immunosuppressor treatment will be avoided using this strategy thus patients may benefit from two cellular infusions. The patients will be followed for 3 and a half years post their second and last MSC infusion.

Inclusion Criteria:

Exclusion Criteria:

Please refer to this study by its ClinicalTrials.gov identifier: NCT02172885

Hospital de Cruces

Hospital Universitario Getafe

Hospital Infantil Universitario Nio Jess, Madrid, Spain

Read the original post:
Mesenchymal Stem Cell Based Therapy for the Treatment of ...