Status:
WITHDRAWN
Cell-Based Therapy for White Matter Repair in Periventricular Leukomalacia
Lead Sponsor:
MGAM LLC
Conditions:
Periventricular Leukomalacia
White Matter Disease
Eligibility:
All Genders
Phase:
EARLY_PHASE1
Brief Summary
The goal of this study is to explore a new treatment that may help repair brain damage in individuals with periventricular leukomalacia (PVL), a condition that affects white matter in the brain. Resea...
Eligibility Criteria
Inclusion
- Diagnosis of periventricular leukomalacia (PVL) confirmed by MRI
- Clinically stable at time of intervention
- Parental or legal guardian consent if participant is a minor
Exclusion
- Severe congenital brain malformations unrelated to PVL
- Active CNS infection or systemic inflammatory disease
- History of severe intraventricular hemorrhage (Grade III/IV)
- Known allergy or history of a significant hypersensitivity reaction to the investigational product or any of its components.
- Participation in another interventional study within the past 30 days
Key Trial Info
Start Date :
January 1 2027
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2031
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06985303
Start Date
January 1 2027
End Date
December 31 2031
Last Update
July 22 2025
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