Category Archives: Stem Cell Treatment


New Study Shows Short-Term Benefits of Stem Cell Therapy for MS Patients, But Long-Term Efficacy Remains Unclear – Managed Healthcare Executive

There have been several studies looking at how MS patients respond to stem cell transplantation, a method where patients are infused with healthy stem cells in hopes of resetting their immune system.

Past research has shown remyelinating and immunomodulatory functions representing a potential therapeutic option for MS patients.

Now, new research, published in Nature Scientific Reports on May 31, revealed that people with MS are more prone to experience a short-term reduction in disability and brain lesion volume after receivingstem cell therapy.

The study, conducted by faculty at Zagazig University in Zagazig, Egypt, was led by Asmaa Ahmed Nawar, and involved a meta-analysis of nine studies detailing randomized clinical trials.

From a literature search of 3,948 records, the research team looked at randomized control trials of stem cell therapy in MS patients in 422 patients collected from PubMed, Web of Science, Scopus and Cochrane Library.

We prepared this study following the PRISMA checklist and performed all the steps according to the Cochrane Handbook for Systematic Reviews of Interventions, Nawar explained. We included cross-over trials to increase the sample size of the analysis to get credible results, and these studies were included until the cross-over point to avoid the carry-over effect in such trials.

From the data, it was determined that stem cell therapy significantly improved MS patients expanded disability status scale following twomonths, and reduced brain lesion volume during the first two months as well. Therefore, the team concluded stem cell therapy does improve the disability of MS patients and reduce their brain lesion volume. The research team further found that stem cell therapy was safe, with zero cases of mortality during the follow-up period.

An interesting finding was that those who received stem cell therapy showed clinical improvements for those patients who received their own hematopoietic stem cells as opposed to those who received mesenchymal stem cells, proving the value of the former.

Despite the positive findings of clinical improvement in the early months, the researchers discovered that after 12 months, there were no differences in disability between patients who underwent stem cell therapy and controls, or individuals with MS who received another treatment or a placebo.

Additionally, the authors noted that those who underwent stem cell therapy showed not significant improvement in motor function, hand dexterity or cognitive function.

Therefore, Nawar and his research team suggested further study of stem cell therapy in MS patients was important, noting in the paper that longer follow-up can help to detect the long-term effect on disease progression and determine any long-term safety concerns. The team also encourages the research of different types of stem cell therapy to better find those that result in optimal results.

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New Study Shows Short-Term Benefits of Stem Cell Therapy for MS Patients, But Long-Term Efficacy Remains Unclear - Managed Healthcare Executive

The Next Berlin Patient: Another Man Cured of HIV After Stem Cell Transplant – POZ

[Editors note: This case was presented at a July 18 press briefing in advance of the International AIDS Conference next week. POZ will update this report, if needed, after the full data are presented on July 24.]

A seventh person appears to be cured of HIV after a stem cell transplant for cancer treatment, according to a case study to be presented at the International AIDS Conference (#AIDS2024) next week in Munich. The man and his donor both have only a single copy of a rare mutation that prevents HIV from entering cells, raising questions about the keys to a functional cure.

The anonymous man was diagnosed with HIV in 2009 and receiveda transplant to treat acute myeloid leukemia inOctober 2015. He stopped antiretroviral therapy in September 2018 and still has sustained HIV remission nearly six years later, Christian Gaebler, MD, of Charite University of Medicine in Berlin told reporters.

The apparent success of this procedure suggests that the stem cell donor pool could be expanded, giving more HIV-positive cancer patients a chance to be cured of HIV. The procedure is too risky for people who dont have life-threatening malignancies, but each case offers new clues.

All these cases are important scientificallywith every case, you learn more about whats possible, and therefore what could be mimicked in an intervention, said International AIDS Society president and conference cochair Sharon Lewin, MD, PhD, of the Peter Doherty Institute at the University of Melbourne. While these cases are very rare, they are inspirational to both people living with HIV and scientists, she added. We need to give people hope but make it realistic.

A Handful of Curesand Some Failures

Antiretroviral therapy can keep HIV suppressed indefinitely, but the virus inserts its genetic blueprints into host cells and establishes a long-lasting reservoir that is nearly impossible to eradicate.

To date, only a small number of people have been cured of HIV after stem cell transplants. The first, Timothy Ray Brownthe original Berlin Patientreceived two transplants to treat acute myeloid leukemia in 2006. In the hope of curing both cancer and HIV, his oncologist, Gero Htter, MD, from the same medical center in Berlin, had the idea to use stem cells from a donor with two matching copiesknown as homozygousof a mutation dubbed CCR5-delta32 that disables a receptor most strains of HIV use to enter cells.

Brown underwent intensive chemotherapy and whole-body radiation to prepare for the transplant. In effect, the conditioning regimen kills off existing malignant immune cells to make room for healthy new ones from the donor. Afterward, he developed near-fatal graft-versus-host disease, which occurs when donor immune cells attack the recipient. As first reported in 2008, he stopped antiretrovirals at the time of his initial transplant, but his viral load did not rebound. Over the years, researchers extensively tested his blood, gut and other tissues, finding no evidence of intact HIV anywhere in his body. At the time of his death in September 2020, he had been free of HIV for more than 13 years.

Three other peopleAdam Castillejo (the London Patient), Marc Franke (the Dsseldorf Patient) and Paul Edmonds (the City of Hope Patient)were also cured after receiving stem cell transplants to treat leukemia or lymphoma from donors with a double CCR5-delta32 mutation. They received less harsh conditioning chemotherapy and experienced milder graft-versus-host disease. All three remain off antiretroviral therapy without viral rebound, their cancer is still in remission and they will appear together at next weeks conference.

Initially, experts assumed Browns cure was attributable to the use of homozygous donor cells with a double CCR5-delta32 mutation. More than a decade ago, Timothy Henrich, MD, now at the University of California San Francisco, described two HIV-positive men in Boston who received transplants of stem cells without the mutation, known as wild-type. These cases generated much excitement as the patients appeared to control HIV after stopping antiretrovirals, but they ultimately experienced viral rebound three months and eight months after treatment interruption.

But Henrichs team later performed a mathematicalmodelinganalysis that predicted a small number of transplant recipients would achieve a cure without CCR5-delta32 stem cells, he told POZ.

In early 2022, researchers described the New York Patient, a middle-aged, mixed-race woman with leukemia who received a combination of umbilical cord blood cells with the CCR5-delta32 mutation and partially matched adult stem cells from a relative without the mutation. Prior to the transplant, she received intensive chemotherapy and whole-body radiation, but she did not develop graft-versus-host disease. The CCR5-delta32 variation is most often found in people of Northern European descent, so this approach could potentially open up the procedure to more people of color. The woman stopped antiretrovirals three years after her transplant and at last report was still free of HIV.

The mystery deepened last year when researchers at the International AIDS Society Conference on HIV Science presented the case of a man known as the Geneva Patient, who appears to have been cured after a wild-type stem cell transplant from a donor with no copies of the CCR5-delta32 mutation. This man received whole-body radiation and chemotherapy and experienced moderately severe graft-versus-host disease. He also used ruxolitinib (Jakafi), an immune-modulating drug that may help shrink the viral reservoir.

Another Berlin Patient

This brings us to the latest casethe new Berlin Patienta man with a single copy of the CCR5-delta32 mutation, known as heterozygous. His doctors were unable to find a suitable donor with two copies of the mutation but found a heterozygous match with one copy. CCR5-delta32 heterozygous individuals can acquire HIV, but the disease generally progresses more slowly. About 16% of Northern Europeans have a single copy of the mutation, while only about 1% have two copies, Gaebler noted.

Prior to the transplant, the man received whole-body radiation and intensive chemotherapy, and he developed mild graft-versus host disease. He achieved full chimerism, meaning all his immune cells eventually originated from the donor, and his leukemia went into remission.

The man discontinued antiretroviral treatment in 2018. Since then, his plasma viral load has remained suppressed, he has no detectable HIV DNA in peripheral blood cells, and duodenal and ileum gut biopsies tested negative. The researchers could not induce virus production from his CD4 cells in the lab. No HIV-specific T cell responses were detected, and his HIV antibodies are decreasing, suggesting there may be no remaining virus to trigger an immune response.

The fact that the man receivedpartiallysusceptible donor cells makes Gaebler more hesitant to declare that hes cured, but if he was going to experience viral rebound, it likely would have happened sooner than six years.

Researchers are still trying to figure out why these seven people were cured with stem cell transplants while other attempts have failed, but there does not seem to be a single decisive factor common to all cases.

Four of the men received transplants from CCR5-delta32 homozygous donors, one received cells from a heterozygous donor, one received wild-type stem cells and the woman received a mix of CCR5-delta32 homozygous and wild-type cells. Four patients underwent intensive conditioning therapy, while three received gentler regimens. Brown and the Geneva Patient experienced severe graft-versus host disease, but the other did not.

Taken together, the seven cases suggest that its not all about CCR-delta32, Lewin said. Its likely that multiple factors play a role in remission, and these may differ from patient to patient. People who receive stem cells from CCR-delta32 wild-type donors have the most susceptible T cells for the virus to target, people who receive stem cells from a heterozygous donoror who are heterozygous themselveshave fewer vulnerable T cells and those with a homozygous donor have few or no susceptible cells. The size of the viral reservoir, the severity of graft-versus host disease and individual immune response are also important.

We believe there was depletion of the replication-competent HIV reservoir, which cannot lead now to viral rebound, Gaebler said. He thinks allogeneic immunity, or the immune response of the donor stem cells, might be key. Having one or two copies of the CCR5-delta32 mutation provides an additional safety layer to give us protection with a resistant immune system, but based on the new case and that of the Geneva Patient, it is possible to cure HIV even when functional receptors for the virus are present. Maybe we do not fully need to achieve complete depletion.

Henrich suggested that the conditioning regimen and graft-versus-host response may be key,while using CCR5-delta32 heterozygous donor cells leaves the virus with fewer targets. This case demonstrates that by dramatically reducing the pretransplant HIV reservoir and maintaining this reduction over time with beneficial graft-versus-host effects, long-term remission remains a possibility for a small number of people even without CCR5-delta32 homozygous donor cells, he told POZ.

Stem cell transplantation is an arduous procedure limited to people with advanced cancer, and it is far from a feasible solution for the vast majority of people living with HIV worldwide. But each new case provides clues that could lead to a more widely applicable functional cure. Some researchers, for example, are exploring whether gene editing approaches such as CRISPR could be used to delete or disable CCR5 receptors to make an individuals own immune cells resistant to HIV.

The next Berlin Patients experience suggests that we can broaden the donor pool for these kinds of cases, although stem cell transplantation is only used in people who have another illness, such as leukemia, Lewin said. This is also promising for future HIV cure strategies based on gene therapy, because it suggests that we dont have to eliminate every single piece of CCR5 to achieve remission.

[This report has been updated to include comments from Timothy Henrich]

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The Next Berlin Patient: Another Man Cured of HIV After Stem Cell Transplant - POZ

T&C Tried & True : The Hair Growth Trio That Banishes Thinning – Town & Country

Here at T&C, we pride ourselves on our discerning eye for quality. With

Last year, I became completely obsessed with my hair health and went on a bit of a re-growth journey. After obsessing over how much hair I seemed to be losing, I took matters into my own hands and started regularly using an LED Red Light helmet to boost my follicles, and I haven't looked back since. While talking to an expert, though, I was made aware that while the benefits of LED to hair growth are measurable, there is an added benefit to topical productions or even supplementation in tandem with regular use of LED. My next step, was finding a topical regimen that would help boost my growth.

For that, I have turned to Act + Acre, with emphasis on their Stem Cell Shampoo and their 3% Stem Cell Peptide treatment. The difference I noticed was remarkable. It should be noted that I originally used the system with a hair mask, and the set has now been discontinued, but the shampoo, conditioner, and treatment are just as easily integrated as a complete routine. When I first started with the shampoo, I took to washing my hair every day, but then was able to get myself back to a place where I was washing every other day. The double cleanse, starting at the nape and working your way up, is key. I found that the lather was considerable and in general my hair was left feeling clean and balanced, without being stripped. This is notable because my hair is baby fine. Another major thing I noticed was that I was losing, and still lose, far less hair in the shower and when I brush than I used to, ever since starting with the program. Reassuring! Not only would I be stimulating growth, but losing fewer hairs that I already have? Sign me up.

As for the special sauce, Act + Acre leverages a trademarked and clinically vetted blend of grape stem cells to optimize hair follicle function in tandem with growth peptides and caffeine to boost circulation to the scalp, and as a result, further support the hair follicle and hair density. In my experience, this has been incredibly effective.

Within a few months of regular use of the shampoo and the peptide treatment, the thinning at my temples was yielding more baby hairs than ever. I really did see that the addition of topical products boosted the already good results from regular use of LED. The peptide treatment, in particular I felt really made a difference, and I love the tingling sensation when I massage it inthough I will note that it took some trial and error to make sure I didn't overapply and make my strands look dirty.

All in all, I found that this set was noticeably efficacious in boosting my growth when paired with LED. So if hair growth and health is your priority, don't think twice about adding the Stem Cell System to your routine.

As the deputy digital lifestyle director at Town & Country, Roxanne Adamiyatt covers fashion, beauty, wellness, design and travel.

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T&C Tried & True : The Hair Growth Trio That Banishes Thinning - Town & Country

What Parents Should Know About Cord Blood Banking – The New York Times

Pregnant women are bombarded with advertisements on social media, in childbirth classes, even in their doctors offices urging them to bank the blood in their babys umbilical cord and gain peace of mind.

Private banks claim that the stem cells inside the blood are a powerful tool to have on hand in case a child one day becomes seriously ill. They charge several thousand dollars upfront for storage plus hundreds more every year thereafter.

But an investigation by The New York Times found that leading banks have consistently misled parents about the technologys promise. The few parents who try to withdraw samples often find that they are unusable either because their volume is too low or they have been contaminated with microbes.

Heres what parents should know about cord blood banking.

In the 1990s, transplant doctors saw cord blood as a promising new source of stem cells for patients with sickle cell anemia and leukemia who could not find suitable matches from their families or bone marrow donor registries.

The major cord blood banks Cord Blood Registry, ViaCord and Cryo-Cell told The Times that the cells they store had saved childrens lives and that no one knew what scientists may one day discover.

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What Parents Should Know About Cord Blood Banking - The New York Times

Stem cell therapy leads to short-term disability reduction in MS – Multiple Sclerosis News Today

People with multiple sclerosis (MS) tend to experience a short-term reduction in disability and brain lesion volume after receiving stem cell therapy, according to a meta-analysis of nine studies detailing randomized clinical trials.

After six and 12 months, however, the researchers found no differences in disability between patients who underwent stem cell therapy and controls, or individuals with MS who received another treatment or a placebo. Moreover, the use of the stem cell therapies did not significantly improve measures of motor function, hand dexterity, and cognitive function among patients.

Clinical improvements occurred primarily among individuals who received their own hematopoietic stem cells (HSCs), or stem cells that give rise to blood cells, and were less evident in a group that received another type of stem cells called mesenchymal stem cells (MSCs).

The scientists said more studies of stem cell therapy in MS were needed, noting that longer follow-up of [randomized controlled trials] will help to detect the long-term effect on disease progression and determine long-term safety concerns.

We also encourage [clinical trials] to compare different routes of [stem cell therapy] to determine the administration route that yields optimal results, the team added.

Their findings were detailed in Efficacy and safety of stem cell transplantation for multiple sclerosis: a systematic review and meta-analysis of randomized controlled trials, published in the journal Nature Scientific Reports.

In MS, the immune system mistakenly attacks the fatty protective layer around nerve fibers, called the myelin sheath. Because myelin helps speed electrical signals, its loss leads to deficits in neuronal communication and a range of MS symptoms.

A stem cell transplant represents a potential way to reset the faulty immune response and stop these misguided inflammatory attacks. It typically involves partly or fully wiping out a patients immune system with a course of chemotherapy or radiation therapy a preparatory treatment known as immunosuppression and then replacing it with HSCs that can grow into healthy immune cells.

In addition to HSCs, mesenchymal stem cells, which can develop into bone, cartilage, and fat cells, are also commonly used in MS therapy. However, these cells are mainly designed to produce signaling molecules that boost neuronal survival and do not require immunosuppression to work.

In clinical trials, stem cell therapy has generated promising results in clinical and quality-of-life improvements in MS patients. Still, these studies followed different protocols regarding dosage, the origin of stem cells, and the route of administration.

These variations limited finding the transplantation approach that produces the optimal benefits for MS patients, the researchers wrote.

When faced with varying findings in the medical literature, scientists can conduct a meta-analysis, which pools data from multiple studies that address a similar research question. Such analyses can find patterns or trends, help clarify conflicting findings, and summarize current research to guide future studies.

In this report, a team of researchers in Egypt conducted a meta-analysis to assess the efficacy and safety of various stem cell transplant approaches in MS. The team pooled data from nine randomized controlled trials that enrolled a total of 422 MS patients.

Two studies applied immunosuppression before autologous HSCs, using the patients own stem cells, while seven studies transplanted MSCs without immunosuppression. All studies infused stem cells intravenously, or directly into the bloodstream, except one study, which included an injection into the spinal canal.

The results from all the studies, regardless of stem cell origin, showed that patients who received a stem cell transplant experienced a reduction in their disability after two months. Disability was measured with the commonly used Expanded Disability Status Scale (EDSS).

However, no significant differences between stem cell therapy and control patients were observed at the last reported follow-up for most studies.

Only one study showed that patients who received autologous HSCs plus immunosuppression experienced a significant EDSS reduction at one year. Meanwhile, those treated with MSCs without immunosuppression showed nonsignificant improvement over controls at six months.

EDSS scores before transplants, stem cell doses, and stem cell sources (adult or embryonic) did not appear to influence EDSS outcomes. There were no differences in the number of relapses between the treatment and control groups.

In other outcome measures, stem cell therapy resulted in non-significant improvements in motor function, finger dexterity, and cognitive function. However, when only patients who received HSCs were included, there were significant improvements in motor function and finger dexterity compared with controls.

MRI studies revealed a significant reduction in the volume of brain lesions, or signs of myelin damage, but not in the number of lesions.

This meta-analysis showed that [stem cell transplant] improves multiple sclerosis patients disability at 2 months and reduces their brain lesions volume. However, we cannot generalize our results due to the sparse number of [randomized clinical trials].

Across most adverse events, the difference between transplants and controls was nonsignificant. Administration-related side effects, including infusion site swelling, bruising, and pain, were significantly more common in the transplant group compared with the control group. Autologous HSCs were significantly associated with a higher incidence of blood and lymphatic system-related side effects, the analysis found.

This meta-analysis showed that [stem cell transplant] improves multiple sclerosis patients disability at 2 months and reduces their brain lesions volume, the researchers concluded.

However, we cannot generalize our results due to the sparse number of [randomized clinical trials] assessing [autologous HSC transplant] combined with immunosuppression for MS, they added.

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Stem cell therapy leads to short-term disability reduction in MS - Multiple Sclerosis News Today

Cell BioEngines Raises Additional $2M in Funding – FinSMEs

Cell BioEngines, a NYC-based company researching stem cells in order to develop new cell therapies, raised additional $2M in funding.

The round consisted of $1.75M from SOSV and the Partnership Fund, and $0.25M from Empire State Developments NY Ventures, the states venture capital arm through the Pre-Seed and Seed Matching Fund Program.

The company intends to use the funds to expand operations and its R&D sector.

Led by CEO Dr. Ajay Vishwakarma, Cell BioEngines is a clinical-stage biotech company focused on developing allogeneic off-the-shelf stem cell-derived therapies as drugs for human disease treatment. It leverages its proprietary platform technology using universal non-gene-modified donor blood stem cells obtained from umbilical cord to produce clinical grade cells at scale.

Commenting on the news, Ajay Vishwakarma said: The funds will support our first multicenter clinical trial, aimed at hematological cancer patients unable to find a donor and seeking an alternative to HLA-haploidentical blood stem cell transplants. CBE-101 represents a novel approach with expanded cord blood-derived hematopoietic cell therapy, aligned with Cell BioEngines vision to deliver off-the-shelf cell-based therapies to patients.

FinSMEs

22/07/2024

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Cell BioEngines Raises Additional $2M in Funding - FinSMEs

Latest HIV Cure Case Is the Most Encouraging One Yet – Gizmodo

Doctors have apparently cured another person of HIV using a bone marrow transplant. Unlike previous cases, however, the patient was cured without needing donated stem cells from someone genetically immune to HIV. This development could change our understanding of how best to treat similar patients in the future, though these transplants still arent a practical solution for most people living with the virus.

The success story is a 60-year-old man from Germany who was diagnosed with HIV in 2009. In 2015, he also became diagnosed with acute myeloid leukemia (AML), a form of blood cancer. Doctors eventually advised that he undergo a bone marrow transplant for his AML, a radical treatment that functionally tries to replace a persons immune system with one belonging to a healthy donor.

Doctors at Charit Universitatsmedizin Berlin performed the mans transplant. Years earlier, in 2007, a team there performed the first bone marrow transplant for cancer that resulted in an HIV cure. At the time, the patient decided to stay anonymous and was nicknamed the Berlin Patient. He later revealed himself as Timothy Ray Brown and remained an HIV/AIDS advocate until his death in 2020 from a recurrence of his leukemia. This latest case has also chosen to go anonymous and has been dubbed the next Berlin Patient.

Brown and most others like him in the years since have received bone marrow from donors with two copies of a particular mutation in their CCR5 gene, which regulates the CCR5 receptor found on white blood cells. The mutation, called CCR5-delta 32, makes immune cells naturally resistant to infection from strains of HIV-1 (the more common type of HIV). By transplanting stem cells containing the mutation to HIV patients, the hope is that you can transfer over that resistance as well, allowing their bodies to permanently eliminate the virus.

Just a small percentage of people carry two copies of the CCR5-delta 32 mutation, however, and Charit doctors were only able to find a compatible donor for their patient who carried one copy. But to everyones surprise, the switch still worked. The patient chose to stop taking his HIV medication in 2018 and tests have continued to show no traces of the virus in his system (he also remains cancer-free). The man is now believed to be the seventh person cured of HIV using stem cells, but the first without needing both copies of the CCR5-delta 32 mutation.

The mans case was presented this week at AIDS 2024, the 25th International AIDS Conference.

A healthy person has many wishes, a sick person only one, said the next Berlin Patient in astatement released by the International AIDS Society, which hosts the conference.

At this point, its not clear exactly how the next Berlin Patient was able to clear his HIV completely. People with only one copy of the CCR5-delta 32 mutation can still get infected by HIV, though it does seem to reduce the odds of catching it. So its possible that even one copy is enough to help eliminate its presence in someone already infected. But its also possible that simply flushing away an HIV-infected persons immune system and replacing it with a new one, regardless of whether the CCR5-delta 32 mutation is around, can do the same. That said, other HIV patients who have received stem cell transplants from non-CCR5-delta 32 donors have seen their infections rebound within months, so other factors might be important to a cure, such as how quickly the donated immune system takes over.

Stem cell transplants are a last resort treatment for conditions like leukemia, due to their risky, even potentially life-threatening side effects. And these days most people with HIV can keep the virus in check with antiretrovirals, to the point of no longer being contagious to others. So these transplants will never become a widely used cure for HIV. But the lessons learned from these patients could help scientists develop more practical cures for HIV or help patients who need stem cell transplants for other reasons.

The next Berlin Patients experience suggests that we can broaden the donor pool for these kinds of cases, although stem cell transplantation is only used in people who have another illness, such as leukemia, said Sharon Lewin, president of the International AIDS Society, in a statement. This is also promising for future HIV cure strategies based on gene therapy because it suggests that we dont have to eliminate every single piece of CCR5 to achieve remission.

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Latest HIV Cure Case Is the Most Encouraging One Yet - Gizmodo

Stem Cell Therapy Market to Triple, Reaching USD 52.1 Billion by 2034 at a 12.1% of CAGR – PharmiWeb.com

Stem Cell Therapy Market

The stem cell therapy market is on the brink of explosive growth, with a compound annual growth rate (CAGR) of 12.1% projected over the next decade. Starting at an estimated value of USD 16.7 billion in 2024, the market is expected to surge to an impressive USD 52.1 billion by 2034.

This significant expansion reflects the increasing adoption of stem cell therapies, driven by their potential to revolutionize treatment for a wide range of conditions. From regenerative medicine to chronic disease management, stem cell therapy is unlocking new possibilities in medical science.

As research continues to advance and clinical applications expand, the stem cell therapy market is set to play a pivotal role in transforming healthcare and improving patient outcomes worldwide. This remarkable growth trajectory underscores the importance of continued investment and innovation in this cutting-edge field.

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Competitive Landscape

The market is very competitive because there are many top biotech and pharmaceutical companies in it. It is distinguished by fierce rivalry, quick technical progress, and a significant amount of R&D activity focused on creating cutting-edge stem cell treatments. Businesses are making significant investments in R&D projects with the goal of creating innovative stem cell treatments for a variety of illnesses.

Recent Development in the Stem Cell Therapy Market

A strategic partnership was established in 2020 between Cipla and Stempeutics to launch Stempucel, a revolutionary stem cell therapy for the management of critical limb ischemia. The partnership aims to increase their market share in this quickly developing industry and capitalize on the rising demand for stem cell therapy. Millions of individuals worldwide suffer from critical limb ischemia, a crippling illness for which the introduction of Stempucel is predicted to change the course of therapy.

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Stem Cell Therapy Market to Triple, Reaching USD 52.1 Billion by 2034 at a 12.1% of CAGR - PharmiWeb.com

$2.9M research grant funds technology for MS stem cell therapy – Multiple Sclerosis News Today

The National Institute of Neurological Disorders and Stroke has awarded a $2.9 million, five-year grant to a research project that aims to advance a new technology that could improve stem cell therapies for multiple sclerosis (MS) and other neurological disorders.

The work we plan to undertake has significant implications for regenerative medicine, as it has the potential to develop novel strategies to enhance stem cell delivery for treatment of devastating neurological diseases that remain intractable to current treatments, Stelios Andreadis, PhD, director of the University at Buffalos Cell, Gene and Tissue Engineering Center and one of the projects leaders, said in a university press release.

Fraser Sim, PhD, a professor at the universitys Jacobs School of Medicine and Biomedical Sciences and the director of its neuroscience program, will co-lead the project. This project is a wonderful example of collaborative science, Sim said. Neither of us could do this work alone.

In MS, inflammation in the brain and spinal cord causes damage to myelin, a fatty substance that wraps around nerve fibers and helps them send electrical signals. Myelin damage disrupts neurological signaling, which ultimately gives rise to MS symptoms.

Stem cell therapies for MS and other neurological disorders are gaining increasing interest from researchers. Stem cells are a special class of cells that are able to grow into other types of cells.

The basic aim of stem cell therapy in MS is to introduce stem cells that could make new nervous system cells, such as neurons (nerve cells) and myelin-making cells like oligodendrocyes and Schwann cells.

In order to be used as a therapy, the stem cells need to be injected into a patients brain. In experiments, this has usually been done by simply suspending the cells in a saline solution and injecting them through a syringe.

But emerging data suggest that the physical stress of being suspended in liquid and then squeezed through the needle tends to damage the cells, and as a result, the vast majority of stem cells end up dying soon after they are injected.

Most researchers have just accepted the fact that a lot of cells will die when you transplant them, Sim said. The new project aims to change this.

The researchers are working to develop shear-thinning hydrogels (STHs) to aid in stem cell injections. STHs normally have a gel-like consistency, but become more fluid when pressure is applied for example, when squeezed through a syringe. The general idea is that STHs can help cushion and protect stem cells during injection.

They change their viscosity in response to shear stress, and they can turn back into gel form when the force is removed, after the injection, Andreadis said. The fast transition from solid-like to fluid-like behavior, with increasing shear rate, is essential for successful injection and cell protection. STHs have emerged as promising candidates for the injection of Schwann cells and oligodendrocytes, he said.

In addition to cushioning the cells, the STHs can also be tailored to help promote the cells survival once inside the brain.

With the hydrogel, we can introduce different factors that will allow the cells to overcome the [suppressive] environment thats present in MS lesions, Sim said. We think this will improve the outcome of cell therapy over the vanilla approach using cells in a saline solution.

The researchers have already conducted proof-of-principle experiments of STHs in mice genetically engineered to be unable to make myelin, mimicking a rare progressive neurodegenerative condition called Pelizaeus-Merzbacher disease.

Transplanting human cells with STHs into the animals brains significantly improved the survival of the transplanted cells and enhanced nerve repair in the brain 12 weeks post-implantation, Andreadis said.

Those results will be published in full soon, the university said.

In the newly funded project, the researchers will test STHs in larger animals, aiming to determine the number of cells needed for a brain thats closer in size to a human brain and assess whether the cells are going to the intended parts of the brain.

This is a great opportunity to marry biomaterials science and engineering with neuroscience to develop a therapeutic strategy that can, hopefully, be brought to the clinic to treat devastating diseases and conditions such as MS, Andreadis said. While there is currently no cure, we would like to develop a successful therapy that can limit the diseases development and improve quality of life for MS patients and others who are suffering from neurological disorders.

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$2.9M research grant funds technology for MS stem cell therapy - Multiple Sclerosis News Today

Experts: Don’t believe everyone who is hawking stem cells – The Times of Northwest Indiana

The mailings promised Life Without Pain! via stem cell injections or IVs administered in a patients own home. The allure was obvious: more than 20% of U.S. adults suffer from chronic pain.

A court exhibit from a lawsuit filed by Iowa Attorney General Brenna Bird is seen on a laptop computer May 8 in Urbandale, Iowa.

The flyers invited Iowans to free dinners across the state. Afterward, sales people traveled to potential customers homes for high-pressure pitches disguised as pre-screenings, according to prosecutors. More than 250 people signed up, paying $3,200 to $20,000 each for a total of $1.5 million. For this, a nurse practitioner came to their homes to administer injections and IVs filled with stem cells derived from umbilical cords.

Yet experts and regulators have alternately labeled such treatments as ripoffs, scams or simply unproven. In some cases, studies have documented real harm.

Last fall, Iowas attorney general sued two proprietors responsible for the mailings in her state, naming a Minnesota man who hosts a Christian entrepreneurship podcast and his Florida business partner for allegedly deceiving consumers, many of them elderly.

In bringing the lawsuit, Iowa joined attorneys general in New York, North Dakota, Georgia, Nebraska, Arkansas and Washington state who have sued businesses alleging they fraudulently promoted unproven stem cell treatments.

Stem cells have long fascinated researchers because of their ability to reproduce and, in some cases, transform into other cell types. Because of this, they are thought to hold the potential for treating many diseases and injuries.

But the FDA has approved only a handful of such therapies, and only for certain forms of blood cancer and immune system disorders. Stem cells are considered experimental for most uses, despite being marketed as a treatment for everything from autism and emphysema to sports injuries.

The FDA has repeatedly warned Americans to be wary of businesses hawking unapproved, unproven and costly stem cell therapies, which occasionally have caused blindness, bacterial infections and tumors.

In a 2020 notice, the agency expressed concern about patients being misled about products that are illegally marketed, have not been shown to be safe or effective, and, in some cases, may have significant safety issues.

Dr. Jeffrey Goldberg, chair of ophthalmology at the Byers Eye Institute at Stanford University, whose work has documented vision loss in some patients treated with cells removed from patients' own bodies, processed and reinjected, lamented that people are "desperately willing to shell out large sums of money for unproven and in some cases, explicitly sort of sham, so-called therapeutics.

Since August 2017, the FDA has issued about 30 warning letters regarding the unproven treatments.

Experts, including Dr. Paul Knoepfler, a stem cell researcher at the University of California at Davis, and Leigh Turner, a bioethicist at the University of California, Irvine, are among those who have raised alarm that such federal action is too little to regulate a U.S. industry which Turner estimated in 2021 topped 2,700 clinics.

Because states can seek substantial fines against wayward operators, Turner said their legal actions offer promise.

"If you look at them collectively, they might over time start to have an impact, he said.

The FDA offers training to attorneys general pursuing such cases. Dr. Peter Marks, director of the FDAs Center for Biologics Evaluation and Research, said federal regulators partner with state law enforcers in a shared mission.

Iowa Attorney General Brenna Bird speaks during a town hall campaign event for Republican presidential candidate Nikki Haley on May 17, 2023, in Ankeny, Iowa.

That puts people like Iowa Attorney General Brenna Bird on the front lines.

Last year, Bird brought the case over mailers offering Iowans a pain-free life, naming the now dissolved Biologics Health and Summit Partners Group, which operated under the name Summit Health Centers, as defendants. The state also sued the companies' proprietors: Rylee Meek, of Prior Lake, Minnesota, and Scott Thomas, of Thonotosassa, Florida.

Neither man claims to have any medical training. Yet over a series of free dinners across Iowa, attendees listened to their presentations about how stem cells could ostensibly repair damage linked to back or joint pain. The claims came despite an FDA warning that no such product has been approved to treat any orthopedic condition.

One testimonial featured a woman quoted as saying she had multiple sclerosis, fibromyalgia, degenerative joint problems and scoliosis. It implied the treatment worked so well she was able to stop using a walker and taking opioids. Prosecutors say that left people believing stem cells are effective at treating all the conditions listed.

The company offered packages ranging from 5 million cells to up to 60 million to fix customers' ailments. Iowas lawsuit described the practices as scattershot, for-profit experimentations.

Research has shown dead cells are often injected, Knoepfler said.

The Iowa case is still in the discovery stage, with the trial set for March 2025.

Meek and Thomas did not return multiple text and email messages from The Associated Press. Nor did their attorney, Nathan Russell, though he did rebut many of the allegations in court filings, including that the promotional information was deceptive or misleading. The filing stressed that Meek and Thomas always emphasized they were not doctors.

Instead, Meek promoted himself as the $100 million man and touted his business prowess on his Kings Council podcast. His and Thomas book, Intentional Influence in Sales: The Power of Persuasion with Neuro-linguistic Programming, is described as a way to get people to think the way you want them to think, without them even realizing it.

Nearly a quarter of Americans struggle with symptoms of depression, according to the latest Centers for Disease Control and Prevention data from an October 2023 survey. That number is down from 2020 to 2021, when the COVID-19 pandemic exacerbated mental health conditions for millions of Americans.

Like other forms of mental illness, depression impacts groups of people differently depending on their unique backgrounds and experiences. While depression is among the most common forms of mental illness, some portions of the U.S. are seeing rates of depression fall faster than others.

Northwell Health partnered with Stacker to look at which groups of people are the most likely to feel depressed, using data from the CDC.

Signs someone may have depression include an inability to focus, thoughts of death or suicide, hopelessness, and low self-worth, as well as changes in appetite and sleep patterns, according to the World Health Organization.

Depression can be transitorybrought on by the loss of a loved one or other difficult life eventsor chronic, such as for those who live with bipolar disorder. The latest data on depression rates suggest some of the uptick in depression during COVID-19 may have been more of the former.

Depression has lingered at elevated levels for some communities, including young people and those who identify as part of the LGBTQ+ community.

Americans ages 18 to 29 years old report the highest levels of depression, with those 30 to 49 years old showing the next highest levels, according to the CDC. Rates of depression taper off even more as Americans clear the age of 60.

Higher reported rates of depression in young people could partially be attributed to the way each generation views mental illness. Members of Gen Z, those born between 1997 and 2012, have been more open to talking about mental illness and seeking therapy, for example, than older generations who came of age at a time when mental health disorders were heavily stigmatized in media and popular culture.

Surveys have found that discrimination is often cited as a significant source of stress; Black and Hispanic adults, specifically, report higher levels of stress from discrimination compared to their white peers.

When it comes to depression rates, a similar trend appears. Hispanic, multiracial, and Black Americans report elevated rates of depression compared to white Americans, according to the latest survey data the CDC collected in late 2023.

Furthermore, LGBTQ+ Americans have reported higher levels of stress and mental illness compared to straight, cisgender people. Transgender individuals are also more than six times as likely to attempt suicide, according to a Swedish study published in The American Journal of Psychiatryone of the only studies to compile such data for an entire country over a 10-year period.

The current rates of depression among more vulnerable groups are particularly concerning at a time when mental health professionals are struggling to meet a higher demand for mental health care services.

Story editing byShannon Luders-Manuel. Copy editing by Tim Bruns.

This story originally appeared on Northwell Health and was produced and distributed in partnership with Stacker Studio.

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Experts: Don't believe everyone who is hawking stem cells - The Times of Northwest Indiana