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

20 Participants Needed

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.

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.

What data supports the effectiveness of the treatment Intrathecal Amniotic Fluid Stem Cells for Multiple Sclerosis?

Research suggests that human amniotic epithelial cells (hAECs) and human amniotic mesenchymal stem cells (hAMSCs) have potential therapeutic effects for multiple sclerosis by modulating the immune system, reducing inflammation, and promoting nerve repair. These cells have shown promise in experimental models of MS-like diseases, indicating they might help in managing MS symptoms. ^{1 2 3 4 5}

Is it safe to use amniotic fluid stem cells in humans?

Research shows that amniotic fluid stem cells have been used in various studies and have not been found to form tumors in the body, which suggests they are generally safe for use in humans. They have been tested in animal models and some human trials for different conditions, showing potential for safe application in regenerative medicine. ^{2 6 7 8 9}

How is the treatment of Intrathecal Amniotic Fluid Stem Cells for Multiple Sclerosis different from other treatments?

Intrathecal Amniotic Fluid Stem Cells (AFSCs) are unique because they are derived from amniotic fluid and have the ability to transform into various cell types without forming tumors, unlike some other stem cells. This treatment is novel for multiple sclerosis as it involves injecting these stem cells directly into the spinal canal, potentially offering a new way to repair damaged tissues and modulate immune responses. ^{4 9 10 11 12}

Research Team

Mahmoud Abdelrazek, MD

Principal Investigator

Wake Forest University Health Sciences

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

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Potential Therapeutic Features of Human Amniotic Mesenchymal Stem Cells in Multiple Sclerosis: Immunomodulation, Inflammation Suppression, Angiogenesis Promotion, Oxidative Stress Inhibition, Neurogenesis Induction, MMPs Regulation, and Remyelination Stimulation. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Amnion-Derived Multipotent Progenitor Cells Suppress Experimental Optic Neuritis and Myelitis. [2022]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Therapeutic Aspects of Mesenchymal Stem Cell-Based Cell Therapy with a Focus on Human Amniotic Epithelial Cells in Multiple Sclerosis: A Mechanistic Review. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Immunosuppressive potential of human amnion epithelial cells in the treatment of experimental autoimmune encephalomyelitis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Therapeutic Use of Intrathecal Mesenchymal Stem Cells in patients with Multiple Sclerosis: A Pilot Study with Booster Injection. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Amniotic Fluid Stem Cells for the Treatment of Surgical Disorders in the Fetus and Neonate. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Recruitment of host's progenitor cells to sites of human amniotic fluid stem cells implantation. [2021]

8. Japan pubmed.ncbi.nlm.nih.gov

Human Amniotic Fluid Stem Cells: Therapeutic Potential for Perinatal Patients with Intractable Neurological Disease. [2019]

9. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Therapeutic potential of amniotic fluid stem cells. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Cell fusion phenomena detected after in utero transplantation of Ds-red-harboring porcine amniotic fluid stem cells into EGFP transgenic mice. [2014]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Stem cells derived from amniotic fluid: new potentials in regenerative medicine. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Amniotic fluid as a rich source of mesenchymal stromal cells for transplantation therapy. [2022]