Stem Cell Therapy for Alzheimer's Disease

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Regeneration Biomedical, Inc.

Must be taking: Donepezil, Memantine, AChEIs

Must not be taking: Other AD medications

Disqualifiers: Neurological, Psychiatric, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 28 weeks

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a research study to evaluate the safety of an investigational autologous cell product obtained from participant's own adipose tissue as a possible treatment for Alzheimer disease.

Do I have to stop taking my current medications for the trial?

You can continue taking your current medications if they are stable for at least 3 months and do not include other Alzheimer's medications, except for donepezil, memantine, AChEIs, Vitamin E, fish oil, and gingko biloba.

Do I have to stop taking my current medications for the trial?

The trial allows certain Alzheimer's medications like donepezil, memantine, and some supplements if you've been on a stable dose for at least 3 months. Other Alzheimer's medications are not allowed.

What safety data exists for stem cell therapy using adipose-derived stem cells?

The study titled 'Human Adipose-Derived Mesenchymal Stem Cells in Cell Therapy: Safety and Feasibility in Different "Hospital Exemption" Clinical Applications' provides relevant safety data. It assessed the safety of autologous adipose-derived stem cell (ASC) therapies in 17 patients for various clinical applications. The study found no microbiological, mycoplasma, or endotoxin contamination, no harmful genomic anomalies, and optimal ASC purity. No serious adverse events were reported for up to 54 months, indicating that autologous ASC transplantation is considered safe and feasible for extreme clinical indications. ^{1 2 3 4 5}

Is stem cell therapy using adipose-derived stem cells safe for humans?

Research shows that using adipose-derived stem cells (ADSCs) in humans is generally safe. In a study involving 17 patients treated for bone and skin conditions, no serious side effects were reported for up to 54 months after treatment. ^{1 2 3 4 5}

Is the treatment RB-ADSC a promising treatment for Alzheimer's disease?

Yes, RB-ADSC, which involves using stem cells from fat tissue, shows promise for treating Alzheimer's disease. Studies in mice have shown that these stem cells can improve memory and brain health, suggesting they could help people with Alzheimer's. ^{2 5 6 7 8}

How is the treatment RB-ADSC different from other Alzheimer's treatments?

RB-ADSC uses stem cells derived from fat tissue, which can transform into different cell types and help repair brain damage, unlike most Alzheimer's treatments that focus on managing symptoms rather than regeneration. ^{2 5 6 7 8}

What data supports the idea that Stem Cell Therapy for Alzheimer's Disease is an effective treatment?

The available research shows that Stem Cell Therapy using adipose-derived stem cells (ASCs) has shown promise in treating Alzheimer's Disease in mouse models. In one study, these stem cells were transplanted into mice with Alzheimer's, and the results showed significant improvements in memory and brain health. Another study found that this therapy increased the growth of new brain cells and reduced brain stress, which helped improve thinking skills in the mice. These findings suggest that Stem Cell Therapy could be a beneficial treatment for Alzheimer's Disease. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment RB-ADSC for Alzheimer's Disease?

Research shows that adipose-derived stem cells (stem cells from fat tissue) can improve memory and reduce brain damage in Alzheimer's disease mouse models, suggesting they might help in treating Alzheimer's in humans. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals aged 45-80 with mild to moderate Alzheimer's Disease, who can donate their own fat tissue for treatment and have a caregiver. Participants should be in good health, with stable medications for other conditions, and no recent cancer or stem cell treatments.

Inclusion Criteria

My thinking and memory skills are good.

My other health conditions are stable and I've been on the same medication for 3 months.

I have been diagnosed with mild to moderate Alzheimer's disease.

Exclusion Criteria

I have a neurological condition, but it's not Alzheimer's disease.

I have not had any stem cell implantation in the last 3 months.

I have had cancer within the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intracerebroventricular injections of ex vivo expanded, autologous adipose-derived stem cells (ADSCs) through an Ommaya reservoir

28 weeks

Regular visits for monitoring adverse events and dose escalation

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Follow-up visits for clinical assessments and imaging

What Are the Treatments Tested in This Trial?

Interventions

• RB-ADSC

Trial Overview The study tests the safety of RB-ADSC, a new therapy using participants' own fat-derived cells to treat Alzheimer's. It aims to see if this approach is safe and how it affects the disease symptoms.

How Is the Trial Designed?

Group I: RB-ADSC medium dose Experimental Treatment 1 Intervention

Participants will receive one dose of 5x10\^6 RB-ADSC infused in the previously implanted Ommaya reservoir

Group II: RB-ADSC low dose Experimental Treatment 1 Intervention

Participants will receive one dose of 2x10\^6 RB-ADSC infused in the previously implanted Ommaya reservoir

Group III: RB-ADSC high dose Experimental Treatment 1 Intervention

Participants will receive one dose of 10x10\^6 RB-ADSC infused in the previously implanted Ommaya reservoir

Who Is Running the Clinical Trial?

Regeneration Biomedical, Inc.

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

Adipose-derived stem cells (ASCs) show promise as a potential treatment for Alzheimer's disease (AD), demonstrating significant improvements in memory and neuropathology in Tg2576 mice, a model for AD.

The study indicates that both intravenous and intracerebral transplantation of human ASCs can effectively enhance cognitive function, highlighting their therapeutic potential for neuroregeneration in AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The therapeutic effects of human adipose-derived stem cells in Alzheimer's disease mouse models. Chang, KA., Kim, HJ., Joo, Y., et al.[2018]

Adipose tissue-derived stromal cells (ADSCs) can be isolated from adult human fat and have the potential to differentiate into neuron-like cells, indicating they could serve as a new source for cell transplantation in the central nervous system.

While only 0.1%-0.2% of ADSCs differentiated into neuron-like cells, these cells exhibited key neuronal characteristics, suggesting that ADSCs could be a viable autologous stem cell source for neurological therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The in vitro study of the human adipose tissue-derived stromal cells differentiating into the neuron-like cells]. Yang, L., Zheng, J., Wang, C.[2014]

Adipose-derived stem cells (ADSCs) can be easily harvested from piglets' fat tissue and expanded in culture, maintaining their stem cell characteristics over more than 15 passages.

These ADSCs have the potential to differentiate into neuron-like cells, suggesting that adipose tissue could serve as a viable alternative source for stem cell therapy in treating nervous system injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuron-like differentiation of adipose-derived stem cells from infant piglets in vitro. Huang, T., He, D., Kleiner, G., et al.[2019]

Adipose tissue-derived stromal cells from adult rats can be successfully induced to differentiate into neuron-like cells using beta-mercaptoethanol, demonstrating their potential as a source for central nervous system transplantation.

With an optimal differentiation protocol, 60%-85% of these cells expressed neuron-specific markers, indicating they can effectively take on a neuronal phenotype, which supports their use in regenerative medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adipose tissue-derived stromal cells differentiate into neuron-like cells]. Yang, L., Zheng, J., Liu, X., et al.[2006]

Transplanting adipose-derived mesenchymal stem cells into the hippocampi of Alzheimer's model mice significantly increased the generation of new brain cells, indicating enhanced neurogenic activity.

This treatment not only reduced oxidative stress but also improved cognitive function in the mice, suggesting a potential therapeutic approach for Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adipose-derived mesenchymal stem cell transplantation promotes adult neurogenesis in the brains of Alzheimer's disease mice. Yan, Y., Ma, T., Gong, K., et al.[2021]

Topical treatment with adipose-derived stem cells (ADSC) significantly improved corneal wound healing in injured rat corneas, showing smaller epithelial defects compared to control and adipose-treated eyes.

Histological analysis revealed that ADSC-treated corneas achieved complete re-epithelization with reduced inflammation and fibroblast activation, indicating a beneficial effect on corneal repair mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human adipose-derived stem cells for the treatment of chemically burned rat cornea: preliminary results. Zeppieri, M., Salvetat, ML., Beltrami, AP., et al.[2013]

The study evaluated the safety and efficacy of autologous adipose-derived stem cell (ASC) therapies in 17 patients with severe conditions, finding no serious adverse events over a follow-up period of up to 54 months.

Both ASC-derived products—a scaffold-free osteogenic graft for bone non-union and a biological dressing for chronic wounds—were successfully manufactured and implanted without contamination or genomic issues, demonstrating their feasibility for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Adipose-Derived Mesenchymal Stem Cells in Cell Therapy: Safety and Feasibility in Different "Hospital Exemption" Clinical Applications. Vériter, S., André, W., Aouassar, N., et al.[2022]

Cultured adipose tissue-derived stem cells (ADSC) can enhance the survival, migration, and tube formation of human endothelial cells by secreting important growth factors like VEGF and HGF, indicating their potential role in promoting blood vessel formation.

In a mouse model of ischemia, transplantation of ADSC improved blood flow and capillary density in the affected area after 4 weeks, suggesting that these cells could be an effective therapy for ischemic diseases, although they do not directly become endothelial cells themselves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel autologous cell therapy in ischemic limb disease through growth factor secretion by cultured adipose tissue-derived stromal cells. Nakagami, H., Maeda, K., Morishita, R., et al.[2022]

Adipose tissue-derived stromal cells (ADSCs) successfully expressed the LacZ gene after being transplanted into the brains of adult rats, indicating their potential for gene therapy applications.

The transplanted ADSCs integrated well into the host brain tissue without causing disruption, overproliferation, or gliosis, suggesting they are safe and compatible for use in treating central nervous system disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adipose tissue-derived stromal cells as vector for gene therapy in central nervous system]. Yang, LY., Zheng, JK., Hui, GZ., et al.[2012]

Citations

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

The therapeutic effects of human adipose-derived stem cells in Alzheimer's disease mouse models. [2018]

2. China pubmed.ncbi.nlm.nih.gov

[The in vitro study of the human adipose tissue-derived stromal cells differentiating into the neuron-like cells]. [2014]

3. England pubmed.ncbi.nlm.nih.gov

Neuron-like differentiation of adipose-derived stem cells from infant piglets in vitro. [2019]

4. China pubmed.ncbi.nlm.nih.gov

[Adipose tissue-derived stromal cells differentiate into neuron-like cells]. [2006]

5. India pubmed.ncbi.nlm.nih.gov

Adipose-derived mesenchymal stem cell transplantation promotes adult neurogenesis in the brains of Alzheimer's disease mice. [2021]

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

Human adipose-derived stem cells for the treatment of chemically burned rat cornea: preliminary results. [2013]

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

Human Adipose-Derived Mesenchymal Stem Cells in Cell Therapy: Safety and Feasibility in Different "Hospital Exemption" Clinical Applications. [2022]

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

Novel autologous cell therapy in ischemic limb disease through growth factor secretion by cultured adipose tissue-derived stromal cells. [2022]

9. China pubmed.ncbi.nlm.nih.gov

[Adipose tissue-derived stromal cells as vector for gene therapy in central nervous system]. [2012]