NCT06841068

Intrathecal Amniotic Fluid Stem Cells for Progressive Multiple Sclerosis

A Phase I/II Trial of Intrathecal Delivery of Amniotic Fluid Stem Cells for Primary and Secondary Progressive Multiple Sclerosis

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Multiple Sclerosis, Progressive

Interventions

Type	Name	Description
BIOLOGICAL	Amniotic fluid or placental CD117 stem cells	CD117 (c-Kit) positive stem cells, extracted from ethical fetal sources such as amniotic fluid and placental tissue.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-08-01
• Completion: 2026-11-01
• First posted: 2025-02-24
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study