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
PHASE1/PHASE2
2 participants
INTERVENTIONAL
2004-01-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Interventions
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retroviral SF71-gp91phox transduced CD34+ cells
autologous ex-vivo retroviral transduced (SF71-gp91phox) CD34+ cells
Eligibility Criteria
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Inclusion Criteria
* history of life-threatening severe infections
* no HLA-matched related or non-related donor
* therapy resistent life threatening infections/organ dysfunction
* no other treatment options e.g. BMT
Exclusion Criteria
* HIV infection
* life expectancy \> 2 years
* infections treatable by conventional therapy (antibiotics, allogeneic granulocytes)
18 Years
MALE
No
Sponsors
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German Federal Ministry of Education and Research
OTHER_GOV
Johann Wolfgang Goethe University Hospital
OTHER
Principal Investigators
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Dieter Hoelzer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Goethe University
Locations
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University Hospital, Hematology
Frankfurt, , Germany
Countries
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References
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Ott MG, Schmidt M, Schwarzwaelder K, Stein S, Siler U, Koehl U, Glimm H, Kuhlcke K, Schilz A, Kunkel H, Naundorf S, Brinkmann A, Deichmann A, Fischer M, Ball C, Pilz I, Dunbar C, Du Y, Jenkins NA, Copeland NG, Luthi U, Hassan M, Thrasher AJ, Hoelzer D, von Kalle C, Seger R, Grez M. Correction of X-linked chronic granulomatous disease by gene therapy, augmented by insertional activation of MDS1-EVI1, PRDM16 or SETBP1. Nat Med. 2006 Apr;12(4):401-9. doi: 10.1038/nm1393. Epub 2006 Apr 2.
Other Identifiers
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DeReG 31
Identifier Type: -
Identifier Source: secondary_id
KSG 31
Identifier Type: -
Identifier Source: secondary_id
58/59
Identifier Type: -
Identifier Source: org_study_id