Stem Cells + Light Therapy for Alzheimer's Disease and Autism

(ACIST Trial)

Enrolling by invitation at 3 trial locations

Overseen By Steven Levy, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MD Stem Cells

Disqualifiers: Unstable health, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether stem cells from a person's own bone marrow, combined with light therapy, can improve symptoms in individuals with Alzheimer's disease or autism. The study examines whether these treatments can enhance memory, thinking, and social skills. Participants are divided into three groups: one receives stem cells intravenously, another combines stem cells with light therapy, and the last combines intravenous and nasal stem cell treatments. Individuals with documented memory or social challenges who are stable on their current treatment might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that if you are on treatment for your condition, you should be stable on that treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that treatments using stem cells from bone marrow, administered through an IV, produced positive results for Alzheimer's patients. These treatments were safe and even improved memory and thinking skills, suggesting they are generally well-tolerated.

For those interested in combining stem cells with near-infrared light, current research appears promising. Stem cell therapies have helped treat memory and thinking problems related to brain diseases. This method has been used safely before and could be beneficial.

Researchers have also studied the safety of using stem cells both through an IV and nasally. Delivering stem cells through the nose has been found safe, with no serious side effects reported.

Overall, while more research is needed, these treatments seem safe and well-tolerated based on current evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for Alzheimer's and autism because they use bone marrow stem cells delivered intranasally and intravenously, a novel approach compared to traditional medications. These stem cells have the potential to repair and regenerate damaged brain tissues, offering a different mechanism of action than current drugs, which mainly aim to manage symptoms. Additionally, one treatment arm combines stem cells with near-infrared light exposure, which may enhance the cells' regenerative effects. These innovative methods provide hope for more effective, targeted therapies for conditions that currently lack robust treatment options.

What evidence suggests that this trial's treatments could be effective for Alzheimer's Disease and Autism?

Research has shown that using a person's own stem cells from their bone marrow may help treat Alzheimer's disease. One study found that administering these stem cells through an IV can reduce inflammation and protect brain cells from damage caused by amyloid-beta, a protein linked to Alzheimer's. Studies also report that 85% of patients receiving this therapy experience improvements in their symptoms. In this trial, one arm uses Intravenous Bone Marrow Stem Cell (BMSC) Fraction alone. Another arm combines these stem cells with Near Infrared Light, which might enhance their effectiveness. Additionally, another arm combines intravenous delivery with intranasal delivery of stem cells, potentially reducing harmful protein build-up in the brain. These methods offer hope for improving thinking and behavior in people with Alzheimer's and autism. ^{1 4 6 7 8}

Who Is on the Research Team?

Steven Levy, MD

Principal Investigator

MD Stem Cells

Jeffrey Weiss, MD

Principal Investigator

Coral Springs

Are You a Good Fit for This Trial?

This trial is for adults over 18 with cognitive impairments or diagnoses like Alzheimer's, various dementias, Autism Spectrum Disorder, and other brain diseases. They should be stable on current treatments and have potential to benefit from BMSC treatment without significant risk. Pregnant women or those who may become pregnant within 3 months post-treatment are excluded.

Inclusion Criteria

My doctor believes BMSC treatment could help me with minimal risk.

I have been diagnosed with a condition that affects my thinking, like Alzheimer's or Autism.

I have been diagnosed with a condition like Alzheimer's or Autism that affects my thinking.

Exclusion Criteria

I can undergo a full neurological exam to check my brain function.

In the estimation of the investigator, the BMSC collection and treatment will not present a significant risk of harm to the patient's general health or to their neurologic function

Women of childbearing age must not be pregnant at the time of treatment and should refrain from becoming pregnant for 3 months post-treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive autologous Bone Marrow Derived Stem Cells (BMSC) with or without Near Infrared Light exposure

12 months

Monthly visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

1, 3, 6, and 12 months post-treatment assessments

What Are the Treatments Tested in This Trial?

Interventions

• Intranasal Topical Bone Marrow Stem Cell (BMSC) Fraction
• Intravenous Bone Marrow Stem Cell (BMSC) Fraction
• Near Infrared Light

Trial Overview The study tests autologous Bone Marrow Derived Stem Cells (BMSC) administered intravenously and topically through the nose, along with Near Infrared Light therapy. It aims to improve cognitive function in dementia and behavior in adult autism.

How Is the Trial Designed?

Group I: Arm 1 Active Control 1 Intervention

Intravenous Bone Marrow Stem Cell (BMSC) Fraction

Group II: Arm 2 Active Control 2 Interventions

Intravenous Bone Marrow Stem Cell (BMSC) Fraction combined with Near Infrared Light exposure .

Group III: Arm 3 Active Control 2 Interventions

Intravenous Bone Marrow Stem Cell (BMSC) Fraction combined with Intranasal topical Bone Marrow Stem Cell (BMSC) Fraction.

Who Is Running the Clinical Trial?

MD Stem Cells

Lead Sponsor

Trials

6

Recruited

1,500+

Published Research Related to This Trial

Intranasally delivered bone marrow stromal cells (BMSCs) successfully migrated to spinal cord injuries in rats and contributed to improved hind limb motor function and reduced lesion cavity size over 2 to 4 weeks.

While the intranasal route showed some efficacy, the results were not as pronounced as those achieved with intrathecal BMSC administration, indicating that while intranasal delivery is a viable option, it may be less effective than direct spinal delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intranasal delivery of bone marrow stromal cells to spinal cord lesions. Ninomiya, K., Iwatsuki, K., Ohnishi, Y., et al.[2015]

In a phase II trial involving 120 patients with subacute ischemic stroke, intravenous infusion of autologous bone marrow mononuclear stem cells (BMSCs) was found to be safe, with no significant adverse events reported.

However, the study showed no significant improvement in stroke outcomes, as measured by the Barthel Index and modified Rankin scale, indicating that BMSCs did not provide a beneficial effect compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous autologous bone marrow mononuclear stem cell therapy for ischemic stroke: a multicentric, randomized trial. Prasad, K., Sharma, A., Garg, A., et al.[2022]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03724136

Alzheimer's Autism and Cognitive Impairment Stem Cell ... The purpose of the study is to evaluate the use of autologous Bone Marrow Derived Stem Cells (BMSC) as a means to improve cognitive impairment as occurs in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12067764/

Stem cell therapy use in patients with dementia: a systematic ... Studies utilizing SCT demonstrated notable improvements in spatial memory, reduced neuroinflammation, and protection against amyloid-beta (Aβ) toxicity.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12306092/

Intranasal administration of stem cell derivatives for the ... Studies have demonstrated that intranasal administration of stem cell derivatives can reduce Aβ deposition, improve the pathological environment ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352320425001609

Mesenchymal stem cell application in Alzheimer's disease Intravenous administration of mesenchymal stem cells reduces Tau phosphorylation and inflammation in the 3xTg-AD mouse model of Alzheimer's disease. Exp ...

5. dvcstem.com dvcstem.com/post/stem-cell-therapy-for-alzheimers

Stem Cell Therapy for Alzheimer's: Findings and Treatment ... Success Record and Data Management: Based on the patient response gathered so far, DVC Stem has a high success rate of 85% in treatment efficacy. They follow up ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11262880/

A Severe Alzheimer's Disease Patient Improved by ... We report an AD patient at the terminal stage whose symptoms were improved by the intravenous administration of ex vivo-expanded bone marrow-derived ...

7. nature.com nature.com/articles/s41591-025-03559-0

Allogeneic mesenchymal stem cell therapy with ... Laromestrocel improved clinical assessments at 39 weeks compared to placebo, as measured by a composite AD score (secondary end point was met: ...

8. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/Intravenous-Mesenchymal-Stem-Cells-Cognitive-Vitality-For-Researchers.pdf

Intravenous Mesenchymal Stem Cells (MSC) Neuroprotective Benefit: MSC injections show consistent benefits in animal models of. Alzheimer's disease, but standardization of cell preparations will likely ...