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Protocol No. MT2009-09 Principal Investigator Tolar, Jakub
Phase Phase I/II
Age Group Both Scope Local
Secondary Protocol No. MMF Funds
Title MT2009-09 Biochemical Correction of Severe Epidermolysis Bullosa by Allogeneic Stem Cell Transplantation
Objective To determine safety and efficacy of stem cell transplant in treatment of severe epidermolysis bullosa.
Treatment Patients will receive a chemotherapeutic regimen followed by marrow stem cell and mesenchymal stem cell transplant.
Description This is a study in patients with epidermolysis bullosa to test the effectiveness of bone marrow or umbilical cord blood from a healthy unaffected donor to correct the collagen, laminin, integrin or plakin deficiency and reduce the skin fragility characteristic of severe forms of EB. The study will also determine whether mesenchymal stem cells from a healthy donor will enhance the safety and effectiveness of the transplant.
Key Eligibility Patient must have a diagnosis of severe epidermolysis bullosa.
Applicable Disease Sites Other Hematopoietic
Skin
Therapies Involved Blood and Marrow Transplant
Chemotherapy
Drugs Involved BUSULFAN (MYLERAN) [SUSPENDED]
CYCLOPHOSPHAMIDE (CYTOXAN, NEOSAR)
CYCLOSPORIN
FILGRASTIM (G-CSF, NEUPOGEN) [SUSPENDED]
FLUDARABINE (FLUDARA)
MYCOPHENOLATE MOFETIL
Mesenchymal Stem Cells (MSC)
Total Body irradiation (TBI)
Status Open
Participating Institutions Masonic Cancer Center
Detailed Eligibility Patients must be between the ages of 0 and 25 years of age. All must have adequate organ function and have an available healthy related or unrelated donor. Anyone with an active infection at time of transplant, history of HIV infection, had prior transplantation with donor skin or evidence of squamous cell carcinoma are not eligible. Women who are pregnant or nursing are not eligible. A signed assent form, informed consent and HIPAA authorization are required.
Treatment Type Non-Cancer Therapeutic
Contact Timothy Krepski Phone:612-273-2800
Email:tkrepsk1@fairview.org