Stem Cell Therapy for Alzheimer's Disease

Overseen By Harshali Patel

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Paul E Schulz

Disqualifiers: TBI, Parkinson's, Multiple sclerosis, others

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

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

12 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment adMSC for Alzheimer's disease?

Research shows that mesenchymal stem cell transplantation can improve brain function in animal models of Alzheimer's disease, suggesting potential benefits for humans. These stem cells have been observed to help with memory and learning in rats with Alzheimer's-like symptoms. ^{1 2 3 4 5}

Is stem cell therapy safe for humans?

In a small study with Alzheimer's patients, stem cell therapy using human umbilical cord blood-derived mesenchymal stem cells was tested for safety, and no major safety issues were reported. Additionally, in animal studies, no cases of cancerous changes were observed after stem cell treatment, suggesting it may be generally safe. ^{1 3 4 6 7}

How is the adMSC treatment for Alzheimer's disease different from other treatments?

The adMSC treatment for Alzheimer's disease is unique because it uses mesenchymal stem cells, which can potentially protect and repair brain cells, reduce inflammation, and replace lost neurons, unlike current treatments that only relieve symptoms without addressing the underlying disease processes. ^{3 4 8 9 10}

What is the purpose of this trial?

The goal of this clinical trial is to learn if stem cell therapy works to treat brain inflammation in adults. Inflammation in the brain may be involved in adults who have memory or thinking problems. The stem cells will be taken from participant's fat samples, processed and given back to participants, so they are their own donor. The main questions this trial aims to answer are: * Does stem cell therapy reduce inflammation in the brain? * Does stem cell therapy improve brain activity? * Does stem cell therapy slow down progression to Alzheimer's disease? Participants will: * Have a small fat biopsy taken at a doctor's office to process stem cells * Receive 4 infusions of stem cells, through a vein in the arm over 12 weeks * Visit the clinic every 2-4 weeks for the first 4 months and then every 1-2 months for 8 months for checkups and tests

Research Team

Paul E Schulz, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for adults with memory or thinking problems due to conditions like early Alzheimer's or mild cognitive impairment. Participants must be willing to have a small fat biopsy and receive stem cell infusions. Specific eligibility details are not provided, but typically there would be criteria related to age, disease severity, and overall health.

Inclusion Criteria

Has an MRI to evaluate AD pathology (may use previous if within 6mo.)

Has signed an informed consent form before any assessment is performed as part of the study

I am between 60 and 80 years old.

Exclusion Criteria

I have the TSPO SNP rs6971 mutation.

I have a condition like TBI, PD, or MS that could affect my thinking.

My condition is stable and does not include severe heart, kidney, liver issues, or autoimmune diseases.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 4 infusions of autologous, adipose-derived Mesenchymal Stem Cells over 12 weeks

12 weeks

4 visits (in-person)

Follow-up

Participants visit the clinic every 2-4 weeks for the first 4 months and then every 1-2 months for 8 months for checkups and tests

8 months

Multiple visits (in-person)

Long-term follow-up

Participants are monitored for safety and effectiveness after treatment

337 days from 1st infusion

Treatment Details

Interventions

• adMSC

Trial Overview The study tests whether stem cells derived from participants' own fat can reduce brain inflammation and improve cognitive function in those showing early signs of Alzheimer's. It involves processing these cells and administering them back into the patient through arm vein infusions over 12 weeks.

Participant Groups

Group I: adMSC Experimental Treatment 1 Intervention

IV-infusions of autologous, adipose-derived, Mesenchymal Stem Cells (adMSCs)

Who Is Running the Clinical Trial?

Paul E Schulz

Lead Sponsor

Trials

2

Recruited

30+

Weston Brain Institute

Collaborator

Trials

13

Recruited

990+

Findings from Research

Intrathecal injection of bone marrow stromal cells (BMSCs) in a rat model of Alzheimer's disease led to the successful migration and differentiation of these cells into cholinergic neurons, which are crucial for cognitive function.

The treatment resulted in an increase in healthy neurons and a decrease in damaged neurons, suggesting that BMSC therapy could be a promising approach for Alzheimer's disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of intrathecal delivery of bone marrow stromal cells on hippocampal neurons in rat model of Alzheimer's disease. Eftekharzadeh, M., Nobakht, M., Alizadeh, A., et al.[2022]

References

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

A Mesenchymal Stem Cell Line Transplantation Improves Neurological Function and Angiogenesis in Intraventricular Amyloid β-Infused Rats. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Therapeutic effect of mesenchymal stem cells in an animal model of Alzheimer's disease evaluated by β-amyloid positron emission tomography imaging. [2021]

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

Stem-cell challenges in the treatment of Alzheimer's disease: a long way from bench to bedside. [2014]

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

In vivo tracking of intravenously injected mesenchymal stem cells in an Alzheimer's animal model. [2020]

5. Ireland pubmed.ncbi.nlm.nih.gov

Bone marrow stromal cells of transgenic mice can improve the cognitive ability of an Alzheimer's disease rat model. [2022]

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

Stereotactic brain injection of human umbilical cord blood mesenchymal stem cells in patients with Alzheimer's disease dementia: A phase 1 clinical trial. [2022]

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

Therapeutic effect of mesenchymal multipotent stromal cells on memory in animals with Alzheimer-type neurodegeneration. [2019]

8. Iran pubmed.ncbi.nlm.nih.gov

The effect of intrathecal delivery of bone marrow stromal cells on hippocampal neurons in rat model of Alzheimer's disease. [2022]

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

Stem Cell Therapies in Alzheimer's Disease: Applications for Disease Modeling. [2021]

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

Human neural stem cells alleviate Alzheimer-like pathology in a mouse model. [2018]