Allogeneic Hematopoietic Stem Cell Transplant For Epidermolysis Bullosa
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ClinicalTrials.gov Identifier: NCT00478244 |
Recruitment Status :
Terminated
(Competing studies)
First Posted : May 24, 2007
Results First Posted : February 11, 2013
Last Update Posted : December 28, 2017
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Sponsor:
Masonic Cancer Center, University of Minnesota
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Epidermolysis Bullosa |
Interventions |
Drug: busulfan Drug: cyclophosphamide Drug: fludarabine phosphate Procedure: hematopoietic bone marrow transplantation |
Enrollment | 7 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | All subjects were registered with the BMT Biostatistical Support Group at the University of Minnesota. |
Arm/Group Title | Epidermolysis Bullosa (EB) Patients |
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Epidermolysis bullosa patients enrolled for treatment with chemotherapy (Busulfan 0.8 or 1.1 mg/kg Days 6-9 before transplant; Fludarabine 25 mg/m^2 Days 3-5 before transplant; Cyclophosphamide 50 mg/kg Days 2-5 before transplant) and stem cell infusion (Day 0) followed by donor epidermal transplant . |
Period Title: Overall Study | |
Started | 7 |
Completed | 6 |
Not Completed | 1 |
Reason Not Completed | |
Did not receive transplant | 1 |
Baseline Characteristics
Arm/Group Title | Epidermolysis Bullosa (EB) Patients | |
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Epidermolysis bullosa patients enrolled for treatment with chemotherapy (Busulfan 0.8 or 1.1 mg/kg Days 6-9 before transplant; Fludarabine 25 mg/m^2 Days 3-5 before transplant; Cyclophosphamide 50 mg/kg Days 2-5 before transplant) and stem cell infusion (Day 0) followed by donor epidermal transplant . | |
Overall Number of Baseline Participants | 7 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 7 participants | |
<=18 years |
7 100.0%
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Between 18 and 65 years |
0 0.0%
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>=65 years |
0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 7 participants | |
6.0 (4.5) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 7 participants | |
Female |
4 57.1%
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Male |
3 42.9%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 7 participants |
7 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | John E. Wagner, M.D. |
Organization: | Masonic Cancer Center, University of Minnesota |
Phone: | 612-626-2961 |
EMail: | wagne002@umn.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Masonic Cancer Center, University of Minnesota |
ClinicalTrials.gov Identifier: | NCT00478244 |
Other Study ID Numbers: |
MT2006-15 CDR0000546620 ( Other Identifier: PDQ ) UMN-0702M01504 ( Other Identifier: IRB, University of Minnesota ) |
First Submitted: | May 23, 2007 |
First Posted: | May 24, 2007 |
Results First Submitted: | July 17, 2012 |
Results First Posted: | February 11, 2013 |
Last Update Posted: | December 28, 2017 |