Gene Therapy for Chronic Granulomatous Disease in Korea
NCT ID: NCT00778882
Last Updated: 2025-09-25
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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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2007-01-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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VM106
VM106
Autologous hematopoietic stem cells with MT-gp91 retroviral vector
Interventions
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VM106
Autologous hematopoietic stem cells with MT-gp91 retroviral vector
Eligibility Criteria
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Inclusion Criteria
* Weigh greater than or equal to 15 kg
* History of severe infections: more than 2 times
* Performance status: ECOG 0-2
* Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases.
* Heart: a shortening fraction \> 28%; QTc interval \< 0.44
* Liver: total bilirubin \< 2 × upper limit of normal; ALT \< 3 × upper limit of normal; AST \< 3 x upper limit of normal
* Kidney: creatine \< 2 x normal
* Blood: WBC \> 2,500/uL; platelet \> 100,000/uL; hematocrit \> 26%
* Written informed consent obtained from patient (or guardian if patients age \< 19)
Exclusion Criteria
* Evidence or history of malignant tumor
* Presence of a severe infection
* Presence of an active tuberculosis
* Uncorrectable electrolyte, Ca, P
* Unable to comply with the protocol or to cooperate fully with the Investigator or site personnel
MALE
No
Sponsors
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Helixmith Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Joong Gon Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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VM106-KR-01
Identifier Type: -
Identifier Source: org_study_id
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