Cell-Based Therapy for White Matter Repair in Periventricular Leukomalacia

Phase

Condition

Neurologic Disorders

Cerebral Ischemia

Stroke

Treatment

Investigational Combination Product

20αHC + oRG cells + ESI1 + ChABC

Clinical Study ID

NCT06985303

MGAM-001

All Genders

Study 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. Researchers are testing whether a combination of a novel cell therapy and specific molecular agents can support brain repair.

The main questions the study aims to answer are:

Can the treatment help regrow white matter and improve myelin repair? Does the treatment reduce scarring in the brain? Is the treatment safe and well-tolerated?

The study uses several components, including:

A specific type of neural progenitor cell to form the basis of the therapy. A small molecule compound to support cell function and survival. An agent designed to promote the repair of the myelin sheath. An enzyme intended to break down scar tissue in the brain. Researchers will study how these components work together to protect and repair the brain by influencing key pathways involved in damage and recovery.

Eligibility Criteria

Inclusion

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

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 theinvestigational product or any of its components.
Participation in another interventional study within the past 30 days

Study Design

Investigational Combination Product

January 01, 2027

December 31, 2031