Amniotic Fluid Stem Cells for Multiple Sclerosis

Recruiting in Palo Alto (17 mi)

Overseen byMahmoud Abdelrazek, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Wake Forest University Health Sciences

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults aged 18-60 with progressive multiple sclerosis, as defined by the McDonald criteria. They should have a certain level of disability but not be affected in specific functions like vision or cognition. Participants must not have changed their MS treatment for at least six months and be considered reliable and stable by their neurologist.

Inclusion Criteria

I have been diagnosed with progressive MS.

Clinically stable as determined by their neurologist for the past 6 months

Can give informed consent

+5 more

Exclusion Criteria

I do not have any active infections or other types of cancer.

I have not had an organ, tissue, or stem cell transplant or cell therapy in the last 3 years.

I have a progressive neurological disorder that is not multiple sclerosis.

+9 more

Participant Groups

Researchers are testing stem cells from amniotic fluid injected into the spinal fluid of MS patients to see if it can improve walking ability and neurological function. This new therapy will involve multiple injections over a year, with close safety monitoring.

1Treatment groups

Experimental Treatment

Group I: Open label stem cell armExperimental Treatment1 Intervention

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.