Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT04476550
Eligibility Criteria:
Inclusion Criteria:
* Male of female aged 3-30
* Documented diagnosis of Pompe Disease
* Participants who has not participated in a cell or gene therapy trial for Pompe Disease
Exclusion Criteria:
* Active acute infection at screening
* Uncontrolled diabetes
* Uncontrolled hypertension
* Active DIC, bleeding or coagulopathy which cannot be corrected with minimal intervention
* Symptomatic, uncontrolled or severe intercurrent illness that would compromise the ability to tolerate blood collection or mobilized leukapheresis procedure
* Systemic chemotherapy less than or equal to 2 weeks (6 weeks for clofarabine or nitrosoureas) or radiation therapy less than or equal to 3 weeks prior to leukapheresis
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test at screening
* Any patient that in the opinion of the investigator is not medically stable to undergo the leukapheresis procedure or will not comply with the visit schedules or procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
30 Years
Study:
NCT04476550
Study Brief:
Protocol Section:
NCT04476550