Intrathecal Amniotic Fluid Stem Cells for Progressive Multiple Sclerosis

NCT ID: NCT06841068

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2026-11-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open label stem cell arm

The first 5 participants will receive 4 intrathecal injections of c-Kit stem cells at a dose of 25 x 106 cells per injection.

The next 5 patients will receive 4 intrathecal injections of c-Kit stem cells at a dose of 50 x 106cells per injection.

The next 10 patients will receive 4 intrathecal injections of c-Kit stem cells at a dose of 80 x 106cells per injection.

Only if a dose is deemed safe by the investigators after 1 month of its first injection, will we advance to the next dose.

Group Type: EXPERIMENTAL

Amniotic fluid or placental CD117 stem cells

Intervention Type: BIOLOGICAL

CD117 (c-Kit) positive stem cells, extracted from ethical fetal sources such as amniotic fluid and placental tissue.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Adults aged 18-60 years.
• Diagnosed with primary or secondary progressive MS according to the 2017 revised McDonald criteria.
• Expanded Disability Status Scale (EDSS) of 3.0 to 8.0 with at least one functional scale that is not vision or sensory or brainstem or cognitive or bowel/bladder that is scoring 3.0 or greater.
• Clinically stable as determined by their neurologist for the past 6 months.
• On no disease-modifying therapy (DMT) for at least 6 months, or on the same DMT for at least 6 months before study entry.
• Can give informed consent.
• Women of child-bearing age must practice adequate contraception techniques in the eye of the investigator and continue to do so during the study period.
• Must be a good candidate, known for compliance for example, in the opinion of the investigators.

Exclusion Criteria

• Participation in another clinical trial within the last 30 days.
• Severe allergic reactions to any component of the study treatments.
• Significant comorbidities.
• Active infections or malignancies.
• History of a malignancy within the past two years except for skin cancer that has been excised and controlled with only surgical treatment, not requiring chemotherapy or radiotherapy.
• Any medical condition that the investigator deems as unsuitable with therapy.
• Prior organ, tissue, or stem cell transplant or cell therapy within 3 years of study entry
• A diagnosis of a progressive neurological disorder other than multiple sclerosis.
• Inability to have an MRI scan.
• Inability to have a lumbar puncture, for example severe bleeding diathesis.
• Pregnant or breastfeeding or intention to become pregnant during the study.
• The results of the following laboratory results deemed suitable by the investigators: CBC with diff, CMP, INR, aPTT, Hepatitis C serology, HIV serology, RPR.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahmoud Abdelrazek, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Atrium Health

Charlotte, North Carolina, United States

Countries

United States

Central Contacts

Mahmoud Abdelrazek, MD

Role: CONTACT

Mahmoud.Abdelrazek@atriumhealth.org

704-403-3000

Facility Contacts

Mahmoud Abdelrazek, MD

Role: primary

mahmoud.abdelrazek@atriumhealth.org

References

Rosner M, Horer S, Feichtinger M, Hengstschlager M. Multipotent fetal stem cells in reproductive biology research. Stem Cell Res Ther. 2023 Jun 7;14(1):157. doi: 10.1186/s13287-023-03379-4.

Reference Type: BACKGROUND

PMID: 37287077 (View on PubMed)

Lassmann H. Pathogenic Mechanisms Associated With Different Clinical Courses of Multiple Sclerosis. Front Immunol. 2019 Jan 10;9:3116. doi: 10.3389/fimmu.2018.03116. eCollection 2018.

Reference Type: BACKGROUND

PMID: 30687321 (View on PubMed)

Other Identifiers

AFSC-PMS-001

Identifier Type: -

Identifier Source: org_study_id