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A Phase I/II Trial of Intrathecal Delivery of Amniotic Fluid Stem Cells for Primary and Secondary Progressive Multiple Sclerosis
In this clinical trial, researchers are exploring a novel approach to delivering therapy directly into the spinal fluid, which surrounds and nourishes the brain and spinal cord. The study focuses on patients with progressive multiple sclerosis (MS), a form of the disease that leads to worsening disability without the typical relapses seen in other MS subtypes. This investigational therapy involves the use of stem cells derived from amniotic fluid-the protective liquid surrounding a developing baby in the womb. To the best of the researchers' knowledge, these specific stem cells have never been tested in MS patients before. Amniotic fluid is ethically sourced from routine medical procedures during pregnancy, and similar stem cells can also be obtained from placentas that are typically discarded after childbirth. Participants in the trial will receive multiple injections of these stem cells into their spinal fluid over the course of a year. Researchers will closely monitor for the safety of this therapy, as well as monitor the participants' walking ability and other neurological functions to assess potential improvements.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
Atrium Health
Charlotte, North Carolina, United States
Start Date
February 1, 2026
Primary Completion Date
August 1, 2026
Completion Date
November 1, 2026
Last Updated
February 6, 2026
Amniotic fluid or placental CD117 stem cells
BIOLOGICAL
Lead Sponsor
Wake Forest University Health Sciences
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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