Amniotic Fluid Stem Cells for Multiple Sclerosis

Overseen By Mahmoud Abdelrazek, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Wake Forest University Health Sciences

Must not be taking: Disease-modifying therapy

Disqualifiers: Active infections, Malignancies, Progressive neurological disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for treating progressive multiple sclerosis (MS) using stem cells from amniotic fluid. The treatment, called Intrathecal Amniotic Fluid Stem Cells, involves injecting these stem cells directly into the spinal fluid, potentially improving walking and other neurological functions. Researchers focus on assessing the safety of this method and observing any potential benefits. Individuals diagnosed with progressive MS, who are clinically stable and have not changed their treatment in the past six months, might be suitable for this trial. Participants will receive multiple injections over a year and will be closely monitored throughout the process.

As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial requires that participants have not been on any new disease-modifying therapy (DMT) for at least 6 months, or they must have been on the same DMT for at least 6 months before joining the study. If you are on a DMT, you may need to continue it or have been off it for 6 months.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that amniotic fluid stem cells have been used in various studies without causing tumors in the body, suggesting safety in that regard. These stem cells are being tested for progressive multiple sclerosis (MS), a condition where symptoms worsen over time.

One study examined a different type of stem cell therapy and found it to be safe and well-tolerated in people with MS. These findings suggest that stem cells can be a safe option, though it's important to note that the specific stem cells in this trial are new to MS treatment.

In this trial, researchers will monitor for any unwanted side effects after injecting the stem cells into the spinal fluid. This careful observation ensures safety. It is important to note that this trial is in the early stages, focusing primarily on safety assessment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for MS?

Unlike the standard treatments for Multiple Sclerosis, which often include drugs that modify the immune system or manage symptoms, this new approach uses intrathecal injections of amniotic fluid stem cells. Researchers are excited because these stem cells have the potential to repair damaged nerve tissues directly, offering a regenerative approach rather than just symptom management. This method could revolutionize treatment by addressing the root cause of nerve damage in MS, potentially leading to improved outcomes for patients.

What evidence suggests that intrathecal amniotic fluid stem cells might be an effective treatment for multiple sclerosis?

Research suggests that stem cells from amniotic fluid might treat multiple sclerosis (MS) by repairing damaged cells in the brain and spinal cord. Early studies show these stem cells can reduce swelling and protect nerves. For people with progressive MS, this might slow the worsening of their condition. Although these specific stem cells have not been tested in MS patients before, similar treatments have shown promise in improving brain and nerve functions. In this trial, participants will receive intrathecal injections of these stem cells directly into the spinal fluid, which researchers hope could lead to better results for patients. ^{1 2 3 4 5}

Who Is on the Research Team?

Mahmoud Abdelrazek, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple intrathecal injections of amniotic fluid stem cells into their spinal fluid over the course of a year

12 months

4 visits for injections

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of walking ability and neurological functions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intrathecal Amniotic Fluid Stem Cells

Trial Overview 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.

How Is the Trial Designed?

Group I: Open label stem cell arm Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06841068?term=AREA%5BBasicSearch%5D(multiple%20sclerosis%20and%20stem%20cells)&rank=8

Intrathecal Amniotic Fluid Stem Cells for Progressive ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

2. withpower.com withpower.com/trial/phase-2-multiple-sclerosis-1-2026-ce356

Amniotic Fluid Stem Cells for Multiple Sclerosis What data supports the effectiveness of the treatment Intrathecal Amniotic Fluid Stem Cells for Multiple Sclerosis? Research suggests that human amniotic ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11111935/

Stem cell therapies: a new era in the treatment of multiple ... This article reviews the application of stem cells in MS, encompassing various stem cell types, therapeutic potential mechanisms, preclinical explorations, ...

4. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/578777

Intrathecal Amniotic Fluid Stem Cells for Progressive Multiple ... The study focuses on patients with progressive multiple sclerosis (MS), a form of the disease that leads to worsening disability without the typical relapses ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S221103482400258X

Neurological efficacy and safety of mesenchymal stem ... Individuals who underwent intrathecal (IT) protocol-based transplantation of mesenchymal stem cells (MSCs) experienced a noteworthy improvement in their ...