Alzheimer’s trial doses patients with stem cell treatment directly to brain – Clinical Trials Arena

California-based Regeneration Biomedical has dosed the first patient has been dosed in a first-in-human trial of its autologous stem cell treatment, RB-ADSC, for patients with mild-to-moderate Alzheimers disease.

The Phase I trial (NCT05667649) of the candidate bypasses the blood-brain barrier (BBB) which most approved and investigated treatments pass through, with Regenerations stem cell treatment, RB-ADSC, being injected directly into the ventricular system.

RB-ADSCs are Wnt-activated adipose-derived stem cells obtained from a patients own adipose tissue. The cells are cultured and expanded in vitro, selected for Wnt expression, and then reintroduced into the patients brain.

The Phase I trial is an open-label, single-arm study which will enroll nine patients over one year. Patients will be randomised into a 3 + 3 dose escalation design to evaluate the safety of autologous RB-ADSC infused into the lateral ventricles of the brain in subjects with mild-to-moderate AD, as well as to determine a recommended dose for a potential Phase II clinical trial.

Secondary endpoints include AD clinical assessments and biochemical and anatomical biomarkers. Each patient will be followed for up to 12 months after treatment.

Founder of Regeneration Biomedical, Christopher Duma, said: Stem cells have represented a novel approach to treatment, but evidence of efficacy has been elusive because systemically administered cells are unable to bypass the BBB and enter the brain. Our RB-ADSC product candidate is designed to overcome the BBB by delivering potentially efficacious stem cells directly to the brain.

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Duma said the company hopes that the therapy will turn on the stem cells that are sitting dormant in the brain to initiate repair and replacement of damaged neurons.

The company has plans to investigate the therapy in other neurodegenerative diseases at Phase II including multiple sclerosis, Parkinsons disease, traumatic brain injury and amyotrophic lateral sclerosis.

Alzheimers disease is a chronic neurodegenerative disease that usually starts slowly in people aged over 65 and worsens over time. It is the most common cause of dementia, accounting for 60% to 70% of all cases. Estimates suggest that as many as 12.4 million patients in the US could have the disease by 2050.

Currently, the only disease-modifying treatments on the market are amyloid targeting treatments Leqembi (lecanemab) and Aduhelm (aducanemab), however, Biogen has decided to discontinue Aduhelm, returning the rights for the drug back to the original developer Neurimmune.

Eli Lilly was hoping that its amyloid targeting therapy donanemab would be on the market by now however it has faced a couple of set back by the US Food and Drug Administration (FDA), with the agency now wanting an Adcomm to further evaluate the unique trial design.

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Editorial content is independently produced and follows thehighest standardsof journalistic integrity. Topic sponsors are not involved in the creation of editorial content.

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Alzheimer's trial doses patients with stem cell treatment directly to brain - Clinical Trials Arena

Stem cells improve memory, reduce inflammation in Alzheimer’s mouse brains – Newswise

BYLINE: Noah Fromson

Newswise When people think of Alzheimers Disease and possible treatment, amyloid and the accumulation of plaques that invade the cerebral cortex is often brought up first.

However, scientists are finding that Alzheimers is influenced by many factors, including neuroinflammation and disrupted metabolism.

By transplanting human neural stem cells, researchers led by Michigan Medicine improved memory and reduced neuroinflammation in a mouse model of Alzheimers Disease, suggesting another avenue for potential treatment.

The results are published inFrontiers in Aging Neuroscience.

The beneficial effects of transplanting human neural stem cells within the brains of Alzheimer's Disease miceoccurred despite amyloid plaque levels remaining unchanged, which lends further evidence that strategies targeting neuroinflammation may be a promising therapeutic strategy, independent of amyloid plaques, saidlead authorKevin Chen, M.D., clinical assistant professor of neurosurgery and neurology at Michigan Medicine.

Additionally, the treatment was associated with normalized inflammation in the microglia, which are the innate immune cells of the brain that become activated with Alzheimers Disease. As the disease progresses, microglia and their inflammatory signaling is thought to contribute to neuron loss.

A team at Michigan MedicinesNeuroNetwork for Emerging Therapies transplanted neural stem cells into the memory centers of transgenic mice that expressed mutations associated with familial Alzheimers Disease. They had both the test mice and control mice perform a task called the Morris water maze to assess spatial memory and learning eight weeks after transplant.

Investigators found that Alzheimers disease mice transplanted with stem cells had their learning curves restored to resemble the control mice with normal learning and memory.

Additional testing through spatial transcriptomics a method to measure gene expression in areas across the brain revealed over 1,000 differently expressed genes that were normalized in the memory centers of the Alzheimers Disease mice after transplantation.

In analyzing the gene expression changes specifically in microglia, the genetic markers linked to progression of Alzheimers Disease were also restored to levels close to control mice. This suggested a reduction in neuroinflammation and disease progression.

Researchers say the improvements reported after stem cell transplantation must be further studied in mice before advancing to larger animals and, eventually, humans.

Our research is incredibly important and continues to support the promise of stem cell therapies in neurodegenerative diseases, according tosenior authorEva Feldman, M.D., Ph.D.,director of the ALS Center of Excellence at U-M and James W. Albers Distinguished University Professor at U-M.

These preclinical studies are the required first step on the road to stem cell therapies.

Additional authors:Include Mohamed H. Noureldein, Ph.D., Lisa M. McGinley, Ph.D., John M. Hayes, Diana M. Rigan, Jacquelin F. Kwentus, Shayna N. Mason, Faye E. Mendelson, all of University of Michigan, and Masha G. Savelieff, CRED, of University of North Dakota.

Funding:This research was supported by the National Institutes of Health, The Handleman Emerging Scholar Program, the NeuroNetwork for Emerging Therapies, The Robert E. Nederlander Sr. Program for Alzheimers Research, the Sinai Medical Staff Foundation and an Alzheimer's Association grant.

Michigan Research Core:Advanced Genomics Core

Citation:Human neural stem cells restore spatial memory in a transgenic Alzheimers disease mouse model by an immunomodulating mechanism,Frontiers in Aging Neuroscience. DOI:10.3389/fnagi.2023.1306004

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Stem cells improve memory, reduce inflammation in Alzheimer's mouse brains - Newswise

Celebrities Quietly Paying Huge Amounts for Anti-Aging Stem Cell Therapy That May Cause Gruesome Side Effects – Yahoo Canada Shine On

Age is just a number. Or, in the era of immortality-obsessed elites, it's just the number of bizarre, supposedly youth-preserving stem cell treatments you can afford.

One celebrity to recently come clean about their use of these experimental treatments is British actor and comedian John Cleese. In an interview with Saga Magazine, the 84-year-old revealed that for the past two decades, he's been spending around 17,000 the equivalent of about $21,000 a year on a private stem cell therapy to stave off aging.

Sure, the Monty Python co-creator is looking pretty good for his age. But experts warn that not only are the purported benefits of these therapies unproven, they may even be outright damaging to our bodies, possibly leading to gruesome outcomes like cancer.

The private clinics that provide these treatments, they warn, operate in "regulatory gray zones" in countries like the US and Switzerland where Cleese gets his treatment preying on the public's lack of understanding on the science behind the technology.

"These clinics may be operating outside of regulatory oversight and scientific collaboration, and do not publish the protocols or outcomes of what they are doing to patients that pay for their services," Anna Couturier at the European Consortium for Communicating Gene and Cell Therapy Information (EuroGCT) told The Telegraph.

Of course, there's a reason that stem cells have their reputation as a miracle of science. Not only are they remarkably good at renewing themselves, the so-called "pluripotent" ones are capable of developing into virtually any kind of cell in the human body. They're basically jacks of all trades, and it's these properties make them ideal for regenerating damaged or even lost tissue.

Perhaps one day advances in this field will let us regrow limbs like frogs. Even now, stem cells already have a well established use in treating leukemia patients by being transplanted into diseased bone marrow.

"You're looking to get rid of the disease and then replace the blood system with some fresh stem cells," Jon Frampton, a stem cell biologist at the University of Birmingham, told The Telegraph. "It's tried and tested and proven to work."

Things get shady beyond these limited proven uses, though. Some anti-aging treatments purport to make you look younger by replenishing the collagen in your face despite there being limited evidence to support them and the potential downsides don't sound worth the risk.

"If put into the wrong context without the right prompts and cues, stem cells do what they're capable of doing but in a very random way," Frampton told The Telegraph. "You can get a tumor called a teratoma, because the stem cells grow a lot and form a lump."

There's also considerable risks about the way these stem cells are administered.

"If the product is not sterile, it can lead to inflammation and, in worst case scenarios, septic shock," Darius Widera, a professor of stem cell biology and regenerative medicine at the University of Reading, told The Telegraph. "Many patients have been harmed by these gray zone clinics."

It's not that stem cells can't live up to the sky high potential we've predicted for them. But we should be skeptical about rushing to use them in these dubious, supposedly age-defying applications. Whatever your anxieties about getting old, it's best to let the science catch up first.

More on stem cells: Scientists Grow Teeny Tiny Testicles in Laboratory

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Celebrities Quietly Paying Huge Amounts for Anti-Aging Stem Cell Therapy That May Cause Gruesome Side Effects - Yahoo Canada Shine On

Trial testing Parkinson’s cell therapy ANPD001 treats 1st patient – Parkinson’s News Today

A Phase 1/2 clinical trial dubbed ASPIRO thats testing Aspen Neurosciences ANPD001 a stem cell therapy candidate designed to replace the nerve cells that are lost in Parkinsons disease has dosed its first patient.

A first transplant was conducted at the Banner-University Medical Center Tucson by neurosurgeon Paul Larson, MD, the trials lead investigator, Aspen announced in a company press release

ASPIRO (NCT06344026), which was cleared by the U.S. Food and Drug Administration (FDA) last year, is testing the long-term safety and tolerability of the ANPD001 stem cell therapy when transplanted at two escalating doses in people with moderate to severe Parkinsons. The eligible study participants range in age from 50 to 70.

The initiation of this clinical trial is a major milestone in Aspens mission to develop and deliver personalized, regenerative neurologic therapies for people with unmet medical needs, starting with Parkinsons disease, said Damien McDevitt, PhD, president and CEO of Aspen Neuroscience.

To date, there is no disease-modifying therapy that can stop, replace or prevent the loss of dopamine neurons or slow the progression of Parkinsons, McDevitt said.

Additional trial goals will include assessments of the therapys early efficacy by measuring so-called on time, or periods when a patients symptoms are controlled by medications and the easing of motor symptoms. The trial is running at five clinical sites in the U.S.

Parkinsons is caused by the death of dopamine-producing neurons in the brains nigrostriatal dopaminergic pathway. That pathway includes the substantia nigra and the dorsal striatum, both involved in motor control. Dopamine is a major brain chemical messenger.

ANPD001 aims to replace the dopaminergic neurons that are lost in Parkinsons.

This experimental therapy for Parkinsons uses a type of stem cell called an induced pluripotent stem cell, or iPSC, which is able to generate nearly any type of cell in the body including dopamine-producing neurons. Its manufacturing is a three-step process.

The first step involves collecting skin cells from a patient, which are then modified in the lab and reprogrammed into iPSCs. The iPSCs are then provided with biochemical cues that guide them into transforming into dopamine neuronal precursor cells. These cells will eventually mature into dopamine-producing neurons once transplanted into patients.

The procedure is known as autologous because it uses a patients own cells.

This is the first use of the autologous approach in a formal clinical trial, saidLarson, also a professor of neurosurgery at the University of Arizona College of Medicine-Tucson.

Larson called it an honor to take part in ASPIRO, saying its an important study.

Parkinsons disease is the most common neurodegenerative movement disorder, primarily affecting the depletion of dopamine neurons in the midbrain, Larson said.

By the time of diagnosis, it is common for people with Parkinsons to have lost the majority of dopaminergic (DA) neurons in the nigrostriatal pathway, which leads to progressive loss of motor and neurological function, Larson said.

The enrolled participants expected to be nine in total were first remotely monitored via a digital health platform, by Rune Labs, as part of a Trial-Ready Cohort Screening study. The goal was to have a comprehensive view of the disease ahead of patient recruitment.

Also included in the trials additional goals, along with increased on time and reduced motor symptoms, is improvement in patients quality of life.

This first-in-human trial holds significant promise to investigate the ability of ANPD001 to improve the lives of people with moderate to advanced Parkinsons disease.

The trials primary phase is expected to be completed by next year, and patients will be assessed for five years post-transplant, with the use of imaging scans of the brain.

This first-in-human trial holds significant promise to investigate the ability of ANPD001 to improve the lives of people with moderate to advanced Parkinsons disease, said Edward Wirth III, MD, PhD, Aspens chief medical officer.

Our 2022 Trial Ready Cohort Screening Study has completed enrollment, and we plan to dose patients in the ASPIRO Phase 1/2a study this year, Wirth said.

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Trial testing Parkinson's cell therapy ANPD001 treats 1st patient - Parkinson's News Today