Stem Cell Research: Alzheimer’s

Research into Stem Cells for Alzheimer’s has been picking up in recent years. 

We’ve broken down each study that’s looking into Stem Cells for Alzheimer’s in detail, but we know it’s a lot to digest. 

At the start of the article, we’ve provided an initial summary of what all the research is telling us. If you want to look at any study in particular, use the Content Table on the left to go to a particular study, or the conclusion at the end of the article.

We hope this is helpful!

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Current Trials looking at Stem Cells treating Alzheimer’s Disease: 2025

HUC-MSC-sEV-001: Nasal Drops for Alzheimer’s

(Full study is here)

What’s Being Tested?
A nasal drop treatment made from human umbilical cord-derived mesenchymal stem cell small extracellular vesicles (hUC-MSC-sEV-001). It’s being tested as a drug intervention.

Purpose:
To evaluate the safety and early signs of effectiveness of this stem cell-derived nasal therapy for neurodegenerative diseases, including:
– Alzheimer’s Disease
-Parkinson’s Disease
– Lewy Body Dementia

Location
Xuanwu Hospital, Capital Medical University, Beijing, China

Timeline:
Start Date: November 2024
Primary Completion: August 2027
Study Completion: August 2028
Status: Not yet recruiting (as of latest update on Sept 25, 2024)

Outcomes Being Measured:

Primary Outcome:
Change in Alzheimer’s Disease Composite Score (ADCOMS)

Secondary Outcomes:
Barthel Index (daily living)
MoCA (cognitive ability)
GDS (depression)
Sleep quality
Olfactory function
Brain MRI changes

Design Overview:
Single group
No control group (NA allocation)
Interventional
No results posted yet

Phase II Allogenic Mesenchymal Stem Cell Study Alzheimer’s-Related Agitation: Miami University 

(Clinical Trial ID: NCT06781333, here’s the full article)

Who’s Running It:
Dr. Bernard Baumel at the University of Miami is leading this study.

Participants:
8 people with moderate to severe Alzheimer’s who are experiencing behavioral symptoms like agitation, aggression, or anxiety.

What They’re Testing:
The trial is exploring whether a single IV infusion of 25 million mesenchymal stem cells (hMSCs) can help reduce these challenging symptoms. The stem cells are not taken from the patient, but come from a healthy donor. Basically they’re using allogeneic stem cells.

Why It Matters:
Behavioral symptoms like agitation are among the most difficult aspects of Alzheimer’s, both for patients and caregivers. This study is testing whether donor-derived stem cells can safely improve these symptoms without relying solely on medications.

What They’re Measuring:

• Changes in behavior and mood, using a tool called the Neuropsychiatric Inventory
  
• Whether patients need less antipsychotic medication
  
• Side effects or safety issues from the treatment
  

Timeline:

• The study is expected to begin in May 2025 and finish by June 2026
  
• It is not yet recruiting participants

Phase I Fat Derived Mesenchymal Stem Cell Study for Early Alzheimer’s: Texas University

(Clinical Trial ID: NCT06775964. Full Article here.)

Who’s Running It:
The trial is being conducted at The University of Texas Health Science Center at Houston. 

Participants:
12 adults between 60 and 80 years old who are in the early stages of Alzheimer’s or at high risk of developing it.

What They’re Testing

This study is testing whether stem cells taken from a person’s own fat tissue (autologous adipose-derived mesenchymal stem cells, or adMSCs) can help reduce brain inflammation and slow down memory loss.

• Participants will undergo a fat biopsy to collect stem cells.
  
• They’ll receive 4 intravenous (IV) infusions of their own stem cells over a 13-week period.
  

• Each infusion contains about 200 million cells in a saline solution.

What They’re Measuring

Primary Outcomes:

• Changes in brain inflammation, tracked using PET scans and biomarkers like TSPO (a signal of activated brain immune cells).
  

• Inflammatory markers in spinal fluid (CSF).

Secondary Outcomes:

• Safety: number of side effects
  
• Changes in memory and thinking using tests like MMSE and RBANS
  
• Changes in Alzheimer’s-related proteins in spinal fluid (like Tau, Amyloid-β, and Nf-L)
  
• Brain metabolism changes via FDG-PET scans
  
• Daily functioning, measured using the Lawton IADL scale
  
• Immune markers in blood and spinal fluid

Timeline:

• Start Date: February 2025
  
• Primary Completion: December 2026
  
• Full Study Completion: January 2027
  

• Recruitment Status: Not yet recruiting

Why This Matters

This is one of the first human trials using a person’s own fat-derived stem cells (autologous adMSCs) to specifically target neuroinflammation in the early stages of Alzheimer’s. Most previous studies have used donor-derived cells or focused on later-stage disease.

Targeting inflammation in the brain is a promising direction because it’s increasingly seen as a major driver of Alzheimer’s progression, not just a side effect.

Regeneration BioMedical Phase 1 Trial: Autologous Fat Derived Stem Cells for Mild to Moderate Alzheimer’s: USA: Ongoing

(Clinical Trial ID: NCT05667649, the full study is here & the interim results were published in a press release.)

This is an ongoing clinical trial sponsored by Regeneration Biomedical, to evaluate the safety of an investigational stem cell therapy called RB-ADSC. 

The therapy uses a person’s own stem cells to treat mild to moderate Alzheimer’s disease. The main goal is to determine a safe dose for future trials. The study is a “first-in-human” trial, which means it’s the first time this specific therapy is being tested in people.

Participants: 

• The trial recruited 6 participants with mild to moderate AD. 
• Participants must be between 45 and 80 years of age and in generally good health. 
• They also need a relative or caregiver to participate with them.

Procedure:

• The study is an open-label trial, which means both the patients and doctors know what treatment is being given.
• Follow up was done 12 months after the injection

Cell Type & Source:

• The study uses autologous adipose-derived stem cells (ADSCs), which means the cells are taken from the patient’s own fat tissue through a procedure called lipoaspirate.
  

Delivery Method:

• The cells are injected directly into the brain’s ventricles (fluid-filled cavities).
• To do this, a soft plastic pouch called an Ommaya reservoir is surgically placed under the scalp.
• The reservoir allows doctors to bypass the blood-brain barrier (a protective layer that prevents substances from entering the brain) and deliver the cells where they need to go.

Dosage: The trial uses a “dose escalation” design, with three different doses:

1. Low dose: 2 million cells
2. Medium dose: 5 million cells
3. High dose: 10 million cells

Culture Method:

• After the cells are collected, they are grown and multiplied in a lab and also “Wnt-activated.”
• This is a specific process designed to enhance their effectiveness.

How the Cells Are Believed to Work

The researchers believe the therapy works by stimulating the brain’s own ability to repair itself and by reducing inflammation.

This “regenerative” approach may be more comprehensive than current treatments that only target specific proteins like amyloid plaques.

The cells are not meant to turn into new brain cells. Instead, they are designed to send out helpful signals to improve the brain’s environment. The direct injection method helps these signals reach their target and maximize the cells’ activity.

Results

• Follow-up duration: 12 to 72 weeks for safety, with secondary outcomes measured at 12 weeks.
• Primary Outcome: The primary goal was to confirm the safety of the therapy, which was achieved with a clean safety profile. No adverse events were observed that were directly attributable to the stem cell injection
• Key Findings:
  • The therapy showed promising early signs of efficacy, with most patients experiencing improvements in cognitive and biomarker scores.
  • Researchers believe the cells worked by stimulating the brain’s own ability to repair itself and reducing inflammation, rather than turning into new brain cells.
  • The treatment was found to be safe, with no major side effects directly related to the stem cell injection over 12–72 weeks.
• Efficacy Data at 12 Weeks:
  • Cognitive Scores:
    • ADAS-cog improved in 80% of evaluable participants. This is a widely used test to measure the severity of cognitive impairment in patients with Alzheimer’s disease.
    • MMSE improved in 60% of evaluable participants. A test used to check for cognitive impairment and to track a person’s mental status over time.
  • BioMarkers:
    • p-Tau improved in 80% of evaluable participants.
      Lower levels of the p-Tau protein are significant because they suggest the therapy is effectively reducing the harmful protein buildup directly linked to the progression of Alzheimer’s disease.
    • Amyloid PET centiloid scores decreased in 60%. Lower amyloid PET centiloid scores are a good thing because they indicate a reduction in the abnormal amyloid plaques in the brain, which are a key sign of Alzheimer’s disease.
      

What’s Happening Next

The Phase 1 trial has now concluded with six participants.

Regeneration BioMedical announced in a press release in August 2025 has submitted the results to the FDA and is preparing to launch a multi-site, placebo-controlled Phase 2 trial in the United States. 

The team is also planning to explore this approach for other neurodegenerative diseases, including Parkinson’s disease, ALS, multiple sclerosis & chronic traumatic encephalopathy (CTE).

Longeveron’s Phase II Laromestrocel Trial: Bone Marrow Derived MSC Stem Cells for Alzheimer’s: USA: Ongoing

(Clinical Trial ID: NCT05233774. Results were posted here)

Who’s Running It:
This study was led by Longeveron, a biotech company focused on regenerative cell therapies. It was conducted across 10 sites in the U.S., including centers in Florida, Texas, and California.

Participants:
The trial included 50 adults between 60 and 85 years old who had been diagnosed with mild Alzheimer’s disease.

What they Tested

The treatment is called Lomecel-B (laromestrocel). A type of stem cell therapy made from donor bone marrow (these are not the patient’s own cells). These stem cells are known for their ability to reduce inflammation and support blood vessel and brain health.

Participants were randomly placed into four groups:

• Group 1: Placebo (no stem cells), given 4 times
  
• Group 2: One infusion of 25 million stem cells, then 3 placebos
  
• Group 3: Four infusions of 25 million cells
  
• Group 4: Four infusions of 100 million cells
  

All treatments were given through a standard IV drip, once a month for four months.

What They Measured

Main Goal:
Make sure the treatment was safe, looking for side effects or problems on brain scans.

Other Goals:

• Track changes in memory and thinking, using tools like MMSE and ADAS-Cog
  
• Measure brain shrinkage (especially in the hippocampus) using MRI
  
• Look at inflammation in the brain through advanced imaging
  

• See if cognitive improvements matched physical brain changes

What They Found

•  Safe: There were no serious side effects, and no brain issues like swelling or microbleeds on MRI (a common problem in other Alzheimer’s drugs)
  
• Cognitive improvement:
  
  • 60–80% of patients improved on memory and thinking tests
    
• Slowed brain shrinkage:
  
  • Whole brain shrank 48% less compared to placebo
    
  • Hippocampus (a key memory area) shrank 62% less
    
•  Less brain inflammation was seen on imaging
  
• Cognitive improvements matched physical improvements in the brain

Why It Matters

They’re now waiting for top Line results in the final quarter of 2026.

This is one of the most advanced stem cell trials for Alzheimer’s to date. It shows that laromestrocel (Lomecel-B) is safe and may help slow brain degeneration and improve memory  without the side effects seen in other treatments like antibody drugs. A larger Phase 3 trial may be next to confirm these results.

While the treatment showed promising results overall, the study did not report whether higher doses led to better outcomes, so it’s still unclear if more cells provide more benefit.

Previous Studies Looking Stem Cells Treating Alzheimer’s  (post 2020)

Nasal Spray Study Overview: 2022: China

Who’s Running It
This trial was led by Dr. Jianqing Xie and a neurology team at Tianjin Huanhu Hospital and the Tianjin Neurological Institute in China. (Full article is here.)

Methodology
This was a Phase I/II open-label clinical trial testing a new therapy for Alzheimer’s disease using exosomes derived from allogeneic human adipose-derived mesenchymal stromal cells (ahaMSCs-Exos).

Exosomes are small vesicles secreted by cells that carry proteins, RNA, and other molecules. They can travel through bodily fluids and potentially cross into the brain to support cell repair and reduce inflammation.

Key Points

Safety

• No adverse events or serious adverse events were reported.
  
• Participants tolerated the intranasal administration well, even those with elevated IgE levels.
  

• Vital signs and lab tests (liver, kidney, etc.) remained stable and normal throughout the trial.
  

Participants

• 9 patients completed treatment: 5 with mild AD, 4 with moderate AD.
  
• Participants were divided into 3 dosage groups:
  
  • Low: 2×10⁸ particles
    
  • Medium: 4×10⁸ particles
    
  • High: 8×10⁸ particles
    
• Treatment: 2 nasal sprays per week for 12 weeks, followed by 9 months of observation.
  

Efficacy

• Medium-dose group showed the most promising results:
  
• Low and high doses were less consistent or showed no significant cognitive improvement.
  
• Amyloid and tau buildup didn’t change much overall, though one high-dose patient showed a notable reduction in amyloid levels.

Mechanism

• Exosomes carried over 1,400 proteins and 277 microRNAs, including:
  
  – Neurotrophic and anti-inflammatory factors
  – Molecules linked to neurogenesis, synaptic plasticity & cell protection
  
• These molecules are believed to support brain repair and cognitive function.

Limitations & Next Steps

• Small sample size and no control group
  
• Participants varied in disease severity and age, which may have affected results
  
• Future trials should:
  
  • Use a randomized, placebo-controlled design
    
  • Focus on mild AD or early intervention
    
• Explore dose optimization and mechanisms of action

Why This Matters

This is the one of the first published human clinical trial testing MSC-derived exosomes for Alzheimer’s. Results suggest that medium-dose intranasal exosomes could help slow cognitive decline and maintain daily function with a strong safety profile.

It also provides early clinical evidence that this stem cell-based approach, especially without using whole cells could be a HUGE for treating neurodegenerative diseases like Alzheimer’s.

MediPost’s NeuroStem Trials: South Korea

Study Title: Clinical safety and efficacy of allogenic human adipose mesenchymal stromal cells-derived exosomes in patients with mild to moderate Alzheimer’s disease
Location: Samsung Medical Center, Seoul, South Korea
Sponsor: MEDIPOST
Published: 2021 (Here is the link)

Who Ran the Study?
This research was carried out by doctors and scientists at a top hospital in South Korea to test a new Alzheimer’s treatment using umbilical cord stem cells. These stem cells came from healthy donors and were turned into a treatment called NEUROSTEM®.

Who Took Part

• 9 people with mild to moderate Alzheimer’s disease
  
• All were between 50 and 85 years old
  
• Everyone had Alzheimer’s confirmed by memory tests and brain scans
  
  

What Was the Treatment?

The treatment involved injecting stem cells directly into the brain using a small device placed under the scalp (called an Ommaya reservoir).

Each person got:

• 3 injections total
  
• One every 4 weeks
  

Two dosage levels were tested:

• Low dose: 10 million cells per injection
  

• High dose: 30 million cells per injection

Was it Safe?

Mostly, yes. But there were some short-term side effects:

• Everyone got a fever after the injection
  
• Some people felt sick, had headaches, chills, or muscle aches
  
• These symptoms lasted less than 2 days
  
• No one had long-term problems, and brain scans showed no serious issues
  

Bottom line: The treatment was generally safe, even though it caused brief fevers and discomfort.

Did it Help?

This trial wasn’t designed to prove whether the treatment works. Tt was focused on safety. But the doctors still looked for early signs of improvement:

• Some Alzheimer’s-related proteins (like tau and amyloid) went down right after the injection, but only for a short time.
  
• Memory test scores didn’t really improve.
  
• Brain scans looked mostly the same after a year.
  

So while the stem cells may have had some short-term effects, they didn’t lead to big improvements in memory or thinking, at least not in this small group.

Why This Matters

This was one of the first studies to test whether stem cells from umbilical cords can be safely injected into the brain of people with Alzheimer’s.

Here’s why it’s important:

• The approach was safe enough to keep testing
  
• It showed that repeated brain injections are possible
  
• It raised new questions, like whether higher or more frequent doses are needed to see real benefits

So, What Happened to NEUROSTEM®?

After the initial trial showed the treatment was safe, researchers followed patients for another 3 years to track long-term effects. But here’s the thing, no results have ever been published, and there’s been no press release or update since that follow-up study ended.

Even more telling? The treatment is no longer listed on MEDIPOST’s website.

That usually means one of two things:

• The results weren’t exciting enough to move forward, or
  
• The company quietly shifted focus to other therapies that showed more promise.
  

It doesn’t necessarily mean NEUROSTEM® failed or caused harm, just that it likely didn’t work well enough to justify a larger, expensive trial. Instead of announcing that publicly, the company seems to have just let it fade away.

So for now, NEUROSTEM® looks like a promising idea that didn’t quite pan out. At least not yet.

Reviews looking at Stem Cells Treating Alzheimer’s

In science, a review isn’t a single experiment,it’s more like a big-picture summary. Instead of testing one small idea, reviews look at lots of different studies on the same topic, gather their results, and explain what the overall evidence shows.

Think of it as reading dozens of studies then pulling out the key takeaways. What’s promising, what’s unclear and where more research is needed

2023 Review on Stem Cell Therapies for Alzheimer’s Disease: Iran

You can read more about this review which was published in Dementia & Neuropsychologia

A team of scientists from Tabriz University of Medical Sciences in Iran conducted a systematic review of existing research on stem cell therapies for Alzheimer’s disease (AD). Their goal was to summarize the current evidence on the safety and effectiveness of these treatments

What they looked at

• The researchers conducted a systematic search of several medical databases up to June 2023.

• They reviewed five clinical studies that used cell-based therapies to manage AD in a total of 70 individuals.
• Types of Stem Cells Reviewed: The studies used various types of stem cells, including:
  • Umbilical cord-derived mesenchymal stem cells (UC-MSCs)
  • Adipose-derived stromal vascular fraction (ADSVF)
  • Bone Marrow derived mesenchymal stem cells (Lomecel-B).

What they were trying to find out:

• The main goal of the review was to estimate the safety and effectiveness of these cell-based treatments.
• The review also evaluated how the different studies were designed and the risk of bias.

What they found

1. Effectiveness: The review noted that the studies showed some improvements in biomarkers and clinical outcomes as a secondary finding. However, the researchers emphasized that the evidence for effectiveness is currently limited and based on studies with small sample sizes.
2. Mechanism of Action: The review suggests that the stem cells work through several mechanisms to improve brain health, rather than just replacing cells.
   • Reducing Inflammation: The cells are thought to work by reducing inflammation and oxidative stress in the brain.
   • Supporting Cells: They may help form and maintain the brain’s neural networks by supporting existing brain cells and preventing the buildup of toxic proteins.
   • Promoting Growth: The review also mentions that some studies show the cells’ potential to promote the growth of new brain cells (neurogenesis) and new connections (synaptogenesis).
3. Delivery Methods:
   • Direct Brain Injections: Injections into specific brain regions, like the bilateral hippocampi and the right precuneus.
   • Brain Cavity Injections: Injections directly into the brain’s fluid-filled cavities (intracerebroventricular injection).
   • IV Infusion: Intravenous (IV) injection into the bloodstream.
4. Safety:
   • The therapies were found to be well-tolerated and safe across all five reviewed studies, with no significant safety concerns linked to the injections.
   • Common Side Effects: The most common side effects were mild and short-lived, such as fever, headache, dizziness, nausea and surgical wound pain.
   • No Serious Events: No serious events like tumor formation, cerebral hemorrhage, or hydrocephalus were reported in the long-term follow-up of these studies.

Researchers’ Conclusions

The researchers concluded that cell-based therapies are a promising new therapeutic approach for Alzheimer’s disease because they are well-tolerated and appear to reduce disease progression. 

However, they strongly recommend that future research address the limitations they found, such as the small number of studies, small sample sizes, and a lack of well-designed, randomized controlled trials.

Conclusion

Research into stem cell therapy for Alzheimer’s is global but concentrated, with most trials taking place in the USA and China, alongside a notable study from South Korea.

The most common cell type being studied is the Mesenchymal Stem Cell (MSC), sourced from a patient’s own fat (adipose) tissue, as well as from donor bone marrow and umbilical cords. 

The success of the therapy is not a cure, but rather slowing down the symptoms. The most successful trials have shown improvements in cognitive scores, a reduction in harmful Alzheimer’s-related proteins. However, results are inconsistent, with some trials showing no significant long-term benefits.

How it works

The consensus is that the cells work primarily through paracrine signaling. They release substances that reduce brain inflammation, support existing brain cells, and encourage the brain’s own repair mechanisms, rather than turning into new brain cells.

Dosages vary widely between trials, from a single infusion of 25 million cells to multiple infusions of 200 million cells. 

Three main delivery methods are being explored are intravenous (IV) infusion & direct injection into the brain.

 There is currently no clear evidence to suggest one delivery method is more successful than another; promising results have been seen across all approaches.

Safety is a consistently strong finding across all reviewed trials. The therapies are reported as well-tolerated and safe, with most side effects being mild and short-term, such as fever or headache.

The research is still in its very early stages. Studies are universally limited by very small patient numbers, a lack of placebo-control groups and highly varied methods, which makes it difficult to draw firm conclusions about effectiveness.

If you’re thinking about treatment, be aware commercial clinics won’t always follow the same strict protocols used in these trials, whether it’s the way they test cells before the procedure or the manufacturing standards they follow.