Cell-Based Therapy for White Matter Repair in Periventricular Leukomalacia
Launched by MGAM LLC · May 14, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment to help repair brain damage in individuals with periventricular leukomalacia (PVL), a condition that affects the white matter in the brain. The researchers want to find out if a combination of special cells and certain substances can help regrow white matter, improve the protective covering around nerves, and reduce scarring in the brain. They will examine how these components work together to support brain recovery and ensure the treatment is safe for patients.
To participate in this study, individuals must have a confirmed diagnosis of PVL through an MRI and be in a stable condition at the time of treatment. Parents or legal guardians must give consent for minors to take part. However, individuals with severe unrelated brain conditions, active brain infections, or certain allergies will not be eligible. The trial is currently not recruiting participants, but it aims to provide hope for better treatment options for those affected by PVL.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
About Mgam Llc
mgam llc is a dedicated clinical trial sponsor focused on advancing innovative therapeutic solutions through rigorous research and development. With a commitment to improving patient outcomes, mgam llc specializes in designing and conducting high-quality clinical trials across various therapeutic areas. The company leverages a robust network of experienced professionals and cutting-edge technology to ensure the integrity, efficiency, and compliance of its studies. By fostering collaboration with medical institutions and regulatory bodies, mgam llc aims to bring transformative treatments to market while prioritizing patient safety and ethical standards in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported