Cell-Based Therapy for White Matter Repair in Periventricular Leukomalacia
NCT ID: NCT06985303
Last Updated: 2025-07-22
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WITHDRAWN
EARLY_PHASE1
INTERVENTIONAL
2027-01-01
2031-12-31
Brief Summary
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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.
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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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Experimental: Investigational Combination Therapy
Participants will receive an investigational combination therapy. This therapy consists of a proprietary cell-based component administered with a cocktail of molecular and enzymatic agents. These agents are designed to support cell health, promote myelin repair, and reduce inhibitory factors in the damaged brain tissue. The overall goal of the intervention is to promote white matter regeneration in patients with periventricular leukomalacia by targeting key barriers that prevent natural repair.
Investigational Combination Product
This investigational therapy combines a proprietary, human-derived cell-based component with a unique blend of small molecules and an enzyme. The components are designed to work synergistically to address the complex pathology of white matter injury. The therapy aims to provide a source for cellular regeneration, support the survival of existing cells, enhance the potential for myelin repair, and modify the inhibitory environment of glial scar tissue. This multi-pronged biological intervention is designed to promote neural regeneration and functional recovery in patients with PVL.
Interventions
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Investigational Combination Product
This investigational therapy combines a proprietary, human-derived cell-based component with a unique blend of small molecules and an enzyme. The components are designed to work synergistically to address the complex pathology of white matter injury. The therapy aims to provide a source for cellular regeneration, support the survival of existing cells, enhance the potential for myelin repair, and modify the inhibitory environment of glial scar tissue. This multi-pronged biological intervention is designed to promote neural regeneration and functional recovery in patients with PVL.
Eligibility Criteria
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Inclusion Criteria
* Clinically stable at time of intervention
* Parental or legal guardian consent if participant is a minor
Exclusion Criteria
* 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
ALL
No
Sponsors
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MGAM LLC
INDUSTRY
Responsible Party
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Other Identifiers
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MGAM-001
Identifier Type: -
Identifier Source: org_study_id
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