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Category Archives: Stem Cell Therapy

Unable to find a partner for stem cell therapy, Gamida accepts sale to investment firm to survive – Fierce Biotech

Posted: March 28, 2024 at 2:41 am

Unable to find a partner for stem cell therapy, Gamida accepts sale to investment firm to survive  Fierce Biotech

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Putting Stem Cell-Based Therapies in Context – National Institutes of …

Posted: January 31, 2024 at 2:31 am

November 16, 2022

Karen M. Wai, MD, Theodore Leng, MD, MS, and Jeffrey Goldberg, MD, PhD, Byers Eye Institute at Stanford, Stanford University School of Medicine, Palo Alto, CA

In recent years, the potential of stem cell-based therapies to treat a wide range of medical conditions has given hope to patients in search of novel treatments or cures. At the same time, thousands of rogue clinics have sprung up across the U.S and around the world, offering stem cell-based therapies before being tested for safety and efficacy. When communicating to the public about stem cell-based therapies, it is important to put any treatment claims in context.

Stem cell-based therapies include any treatment that uses human stem cells. These cellshave the potential to develop into many different types of cells in the body. They offer a theoretically unlimited source of repair cells and/or tissues. (For more about stem cells, seehttps://stemcells.nih.gov.)

Over the past three decades, the Food and Drug Administration (FDA) has approved several stem cell-based products. These include bone marrow transplants, which have been transformational for many cancer patients, and therapies for blood and immune system disorders.1 Other approved treatments include dental uses for gum and tissue growth and in skin for burns. Since the early 2000s, stem cell-based therapies have been explored in many eye diseases, including age-related macular degeneration and glaucoma.2 Stem cell-based therapies are also being explored for neurodegenerative diseases such as stroke and Alzheimers disease, and for countless other conditions.

Over time, we expect that breakthroughs will continue with stem cell-based therapies for many conditions. However, at this time, rogue clinics, driven by profits, are taking advantage of patients desperate for cures and are claiming dramatic results, often exaggerated in sensational media testimonials. The clinics may mimic legitimate practices. They may extract a patients own stem cells, concentrate or modify the cells, and then re-inject them. Some manufacturers offer stem cell-based derived products, such as biologic eye drops made with placenta extract or amniotic fluid to treat dry eye. Clinics may provide misleading information and advertise their practice as running clinical trials. However, these clinics almost always work without FDA regulatory approval and outside of legitimate clinical trial approaches.

These unproven, unregulated stem cell treatments carry significant risk. The risks range from administration site reactions to dangerous adverse events. For example, injected cells can multiply into inappropriate cell types or even dangerous tumors. A 2017 report described one Florida clinic that blinded patients with stem cell eye injections.3

The Pew Charitable Trusts gathered 360 reports of adverse events related to unapproved stem cell therapies, including 20 cases that caused death.4 Further, adverse events are likely underreported because these products are not FDA approved or regulated. Many unproven stem cell-based therapies cost thousands of dollars to patients and are not covered by insurance. Further, even if patients avoid adverse events from these therapies, they may suffer consequences from delaying evidence-based treatments.

The FDA has made substantial progress toward regulation of stem cell-based therapies. In 2017, it released guidance under the 21st Century Cures Act that clarifies which stem-cell based therapies fall under FDA regulation. It also better defined how the agency will act against unsafe or unregulated products.5 As of May 2021, the FDA has more strongly enforced compliance for clinics that continue to market unproven treatments.6

Despite this increased regulation, rogue clinics are still relatively commonplace. A 2021 study estimated that there are over 2,500 U.S. clinics selling unproven stem cell treatments.7Patients at these clinics are often led to believe that treatments are either approved by the FDA, registered with the FDA, or do not require FDA approval. It is important to recognize that there are limits to the FDAs expanded reach, especially when it is targeting hundreds of clinics at once. Our clinic at Stanford recently cared for a patient who had received stem cell injections behind his eyes, where he developed tumors that ultimately ruined vision in both eyes.

Progress in stem cell science is rapidly translating to the clinic, but it is not yet the miracle answer we envision. With time, stem cell-based therapies will likely expand treatment options. People considering a stem-cell based therapy should find out if a treatment is FDA-approved or being studied under an FDA-approved clinical investigation plan. This is called an Investigational New Drug Application. Importantly, being registered with ClinicalTrials.gov does not mean that a therapy or clinical study has been authorized or reviewed by the FDA. For more information about stem cell therapies, visit http://www.closerlookatstemcells.org, a resource from the International Society for Stem Cell Research.

As we look hopefully to the future, we need greater awareness of the current limitations of stem cell therapy and the dangers posed by unregulated stem cell clinics. Strong FDA regulation and oversight are important for ensuring that stem cell-based therapies are safe and effective for patients. Accurate communication to the public, careful advocacy by physicians, and education of patients all continue to be crucial.

References:

1 U.S. Food and Drug Administration, Approved Cellular and Gene Therapy Products, Sept. 9, 2022,https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products.

2 Stern JH, Tian Y, Funderburgh J, Pellegrini G, Zhang K, Goldberg JL, Ali RR, Young M, Xie Y, Temple S. Regenerating Eye Tissues to Preserve and Restore Vision. Cell Stem Cell. 2018 Sep 6;23(3):453. doi: 10.1016/j.stem.2018.08.014. Erratum for: Cell Stem Cell. 2018 Jun 1;22(6):834-849. PMID: 30193132.

3 Kuriyan AE, Albini TA, Townsend JH, Rodriguez M, Pandya HK, Leonard RE 2nd, Parrott MB, Rosenfeld PJ, Flynn HW Jr, Goldberg JL. Vision Loss after Intravitreal Injection of Autologous "Stem Cells" for AMD. N Engl J Med. 2017 Mar 16;376(11):1047-1053. doi: 10.1056/NEJMoa1609583. PMID: 28296617; PMCID: PMC5551890.

4 The Pew Charitable Trusts, Harms Linked to Unapproved Stem Cell Interventions Highlight Need for Greater FDA Enforcement, June 1, 2021,https://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2021/06/harms-linked-to-unapproved-stem-cell-interventions-highlight-need-for-greater-fda-enforcement.

5 U.S. Food and Drug Administration, FDA announces comprehensive regenerative medicine policy framework, Feb. 2, 2022,https://www.fda.gov/news-events/press-announcements/fda-announces-comprehensive-regenerative-medicine-policy-framework.

6 U.S. Food and Drug Administration, FDA Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products, July 7, 2020,https://www.fda.gov/news-events/press-announcements/fda-extends-enforcement-discretion-policy-certain-regenerative-medicine-products.

7Turner L. The American stem cell sell in 2021: U.S. businesses selling unlicensed and unproven stem cell interventions. Cell Stem Cell. 2021 Nov 4;28(11):1891-1895. doi: 10.1016/j.stem.2021.10.008. PMID: 34739831.

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Global Stem Cell Therapy Industry Outlook to 2028, Driven by Therapeutic Innovations and Clinical Advancements … – Yahoo Finance

Posted: January 31, 2024 at 2:31 am

Global Stem Cell Therapy Industry Outlook to 2028, Driven by Therapeutic Innovations and Clinical Advancements ...  Yahoo Finance

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Stem Cell Transplant and CAR T-cell Therapy: The Patient and Care Partner Experience | BMT Infonet – BMT Infonet |

Posted: January 31, 2024 at 2:31 am

Stem Cell Transplant and CAR T-cell Therapy: The Patient and Care Partner Experience | BMT Infonet  BMT Infonet |

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New study on promising stem cell-based therapy for Crohn’s disease – Medical Xpress

Posted: January 31, 2024 at 2:31 am

New study on promising stem cell-based therapy for Crohn's disease  Medical Xpress

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The Trouble With Stem Cell Therapy – Consumer Reports

Posted: December 20, 2023 at 2:38 am

There's no shortage of opportunity for consumers like John Rodolf to encounter the promise and peril of experimental stem cell treatments. They are being studied by blue-chip medical centers like the Mayo Clinic, offered in the exam rooms of dermatologists and orthopedists, and advertised in newspapers and online by more than 500 stem cell specialty clinics.

The level of scientific vetting these treatments have been subjected to runs the gamut. Some have been carefully developed and sanctioned by the FDA; others haven't been formally studied but have some evidence to support their use. Others still are untested and dangerously unscientific.

It can be difficult to tell which of those categories any given stem cell therapy falls into, in part because websites and advertisements that promote bogus treatments can look just as professional and trustworthy as the ones that discuss legitimate clinical trials. "I found out about the Lung Institute in a magazine advertisement in my doctor's office," says Maureen Rosen, a 75-year-old resident of Ocala, Fla., who, like John Rodolf, paid the Lung Institute thousands of dollars for COPD treatments she says didn't work at all. "And it looked impressive to me. And when I went online, the website looked like any other website that you'd see for a hospital."

Another problem is that questionable treatments are sometimes advertised alongside promising ones. For example, according to court documents and a case study published in the New England Journal of Medicine, three women suffered serious vision impairment (one went completely blind) after participating in a study they found listed at clinicaltrials.gov, a website maintained by the National Institutes of Health (NIH).

The site lists more than 1,000 stem cell-related clinical trials. Some of them have secured investigative new drug (IND) approval from the FDA, a process that can take years of research and involves careful vetting of protocols for safety and close monitoring of patients, as a rule. But other trials listed on the site haven't completed those steps, and there's no easy way to tell the two groups apart.

The clinical trial that allegedly cost the three women their vision was administered at U.S. Stem Cell Clinic (USSCC) in Sunrise, Fla. It involved extracting stem cells from the women's belly fat and injecting them into their eyes to treat their macular degeneration. Researchers say the protocol violated basic safety principlessuch as treating only one eye so that the other would be spared in the event of complicationsand that it used a type of stem cell that hasn't demonstrated any potential for treating macular degeneration. "Fat stem cells can only turn into fat," says Temple of the Neural Stem Cell Institute. "There's no reason to think they would do anything for diseases of the eye." U.S. Stem Cell Clinic declined to be interviewed for this article.

The NIH recently added a disclaimer to its clinical trials home page, warning that not all of the listed studies have been vetted by a federal agency. But critics say that notice isn't enough to protect consumers, many of whom are desperate for miracle cures. "Some clinics effectively use this site as a marketing tool," says Leigh Turner, Ph.D., a bioethicist at the University of Minnesota who has studied the stem cell industry. "They post studies there because it gives them an air of legitimacy, which in turn helps them attract patients."

An NIH spokeswoman told Consumer Reports that the government agency is considering additional measures to help consumers navigate the site better, but she didn't mention specifics.

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Stem Cell Therapy Boosts Quality of Life for People With Advanced Heart Failure – MedicineNet

Posted: December 20, 2023 at 2:38 am

Stem Cell Therapy Boosts Quality of Life for People With Advanced Heart Failure  MedicineNet

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The stem cell therapy project Blue4Therapy brought to a highly successful close – Marketscreener.com

Posted: April 7, 2023 at 12:02 am

The stem cell therapy project Blue4Therapy brought to a highly successful close  Marketscreener.com

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Stem Cell Therapy for Spinal Cord Injury – PubMed

Posted: December 27, 2022 at 12:53 am

Traumatic spinal cord injury (SCI) results in direct and indirect damage to neural tissues, which results in motor and sensory dysfunction, dystonia, and pathological reflex that ultimately lead to paraplegia or tetraplegia. A loss of cells, axon regeneration failure, and time-sensitive pathophysiology make tissue repair difficult. Despite various medical developments, there are currently no effective regenerative treatments. Stem cell therapy is a promising treatment for SCI due to its multiple targets and reactivity benefits. The present review focuses on SCI stem cell therapy, including bone marrow mesenchymal stem cells, umbilical mesenchymal stem cells, adipose-derived mesenchymal stem cells, neural stem cells, neural progenitor cells, embryonic stem cells, induced pluripotent stem cells, and extracellular vesicles. Each cell type targets certain features of SCI pathology and shows therapeutic effects via cell replacement, nutritional support, scaffolds, and immunomodulation mechanisms. However, many preclinical studies and a growing number of clinical trials found that single-cell treatments had only limited benefits for SCI. SCI damage is multifaceted, and there is a growing consensus that a combined treatment is needed.

Keywords: AD-MSCs; BM-MSCs; ESCs; EVs; NPCs; NSCs; U-MSCs; iPSCs; spinal cord injury; stem cells.

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How much does stem cell therapy cost in 2022? – The Niche

Posted: December 18, 2022 at 12:57 am

One of the most common questions Ive gotten over the last decade is, how much does stem cell therapy cost? They actually seem most often to want to know more specifically how much itshould cost.

To try to authoritatively answer this now in 2022 we need data from the present and past along with expert perspectives.

These kinds of questions on what are common and reasonable prices have continued in 2022. However, the types of queries have also evolved. Things have gotten more complicated. There are many layers to the question of cost. I cover the key elements here in todays article. In the big picture, the most worrisome potential cost is to your health if you proceed with unproven stem cell injections.

Stem cell cost questions | Stem cells cost $2,500 to $20,000| Why do stem cells cost so much? | How have stem cell prices changed? | Stem cell supplement cost | FTC actions and patients as consumers| Does insurance or Medicare cover stem cell therapy? | Patient fundraising | Looking ahead will stem cell costs go down?| References

This post is the most comprehensive look at stem cell treatment cost and costs of related therapies that Ive seen on the web, especially factoring in our inclusion of historical polling data from past years here on The Niche. The above bullet point list is what is covered in todays post and you can jump to sections that interest you most by clicking on those table of contents bullet points.

You can also watch the video I made summarizing the key points of this post below.

Furthermore, it encompasses other important issues related to insurance, fundraising, and approaches to being a smart consumer. Keep in mind that almost all stem cell therapies outside the bone marrow/hematopoietic sphere are not FDA-approved. They mostly lack rigorous data to back them up too. So this post is definitely not recommending you get them. I advise against it, but many people still want info on cost.

Lets get started.

After more than a decade of blogging about stem cells from just about every angle, its interesting to consider trends in the types of questions I get asked. Beyond cost, I also often get asked How much of a stem cell treatment price does insurance cover?

Of course, insurance (or lack thereof) directly bears on cost too. Ill get more into insurance later in the post.

In a way its not so surprising that cost is so much on peoples minds now for a few reasons.

First, as compared to many years back, people now view stem cell injections as a more everyday thing. Stem cell therapy is often available just down the street at a local strip mall.

Back in 2010 and in the 5 or so years after that, people instead more often viewed stem cells as some amazing thing out of reach to them at that time. Now people view stem cell offerings through the lens of consumers.

Sadly, another major part of the reason for the change in perceptions of stem cell treatments is the tidal wave of stem cell clinics from coast to coast in the US selling unproven and sometimes dangerous offerings.

At the same time, some universities and large medical centers also sell stem cell or similar offerings that arent proven. Im worried that that number may be increasing too and patients who may be paying there for unproven stem cells way at the very high end of the cost spectrum, sometimes above $100K.

Other stem cell suppliers and clinics market stem cell-related stuff that isnt real stem cells such as platelet rich plasma or PRP (see my comprehensive guide to PRP including a helpful infographic here) or injections of often dead perinatal stem cell products.

For all these reasons about once every year or two, I do polling asking the readers of The Niche here about their experiences.

Ive done the polling again now in 2020 in a more comprehensive form.

To have a sense of cost, we need to ask patients certain questions. How much did you pay per injection? How many injections did you get? Where did you get them?

Keep in mind that the total cost of stem cell therapy is the product of the cost per injection times the # of injections. For instance, if a stem cell injection costs $8,000 and you get 10 injections, your total cost is $80,000.

Unfortunately, the unproven stem cell clinics generally do not volunteer data on how much they charge. They also often encourage patients to get many injections.

Our 2020 polling data (you can still participate and I will update this) for stem cell treatments are in the graphic above. Here are some highlights.

The self-reported responses on cost for stem cell treatments, as indicated by respondents to our 2020 polling, suggest the price has gone up.

While the most common answer in 2019 was $2,501-$5,000, in 2020 the most common response was $10,001-$20,000, while $2,501-$5,000 was close behind.

The percentage of people paying the most, more than $100,000, was only slightly (probably non-significantly) higher in 2020, but both in 2019 and 2020 the percentage of people paying over $100K was much higher than in 2018 polling.

Keep in mind this is the cost per injection so how many injections do patients typically get? While the number of injections reported most commonly was 1 in both 2019 and 2020, in 2020, the second most common answer was 6-10 injections, a big boost from 2019. Again, more injections end up multiplying things up to boost the total cost. Only a few people in the polling had many injections, but in my view it is still striking to see anyone say theyve received more than 20 stem cell injections.

For comparison, the 2019 polling can be found here, but some of the key results are captured in a combo screenshot Ive included here. I got a lot more responses to the polling in 2019 so that makes me more confident in the data than in the 2020 polling so far, but I hope well get more responses moving forward in 2020 and if we do, again Ill update the info in this post.

What you can see from 2019 is that a plurality of respondents reported getting one stem cell injection, but 60% of people nonetheless got more than one stem cell injection.

Remarkably about 1 in 20-25 people received more than 20 stem cell injections.

About another 1 in 20 people got 6-20 injections. I find this amount of repeat injections to be surprising and concerning as it amplifies health and financial risks.

In terms of cost per injection, the results are pretty similar to 2018 (see at right below) on the whole.

This kind of polling isnt super scientific, but can gauge trends. Unfortunately, I havent really seen much other published data on stem cell clinic costs in actual journals.

I dont know if its noise or not, but the percentage of people paying over $100K is about 2-fold higher in 2019 versus 2018.

There are more people may be paying $10K-$20K as well now in 2020 vs. 2019 or 2018.

There is growing interest from the public in stem cell supplements. I did a post on this earlier in 2020 so take a look here, which was essentially a review of stem cell supplements like Regenokine. In terms of cost, while supplements are far less expensive than getting stem cell, PRP, or exosome injections, supplements are still pricey for what you get.

Its not unusual to pay $100 for a small bottle of stem cell supplements, the other factor to consider is that these supplements generally have no solid, published data behind them so you might as well be paying $100 for water. Its unclear what risks taking these supplements might bring as well.

On the economic side, you might think that the feds like the FTC would be actively pursuing false or even fraudulent marketing of stem cells via the web and other kinds of advertising, but in total so far the FTC to my knowledge has only taken relatively few actions such as this one. and then some letters for COVID-related marketing of stem cells and other biologics earlier this year in 2020.

Oddly, there were just that a couple blips of FTC activity, especially considering the sea of questionable stem cell clinic-related ads out there. This ranges from major newspapers to inflight magazines to mobile ads on a stem-cell-mobile to television. Then of course there are the infomercial seminars.

Patients should also view themselves as consumers. Savvy customers considering paying money to stem cell clinics should do their homework. I often tell patients to use at a minimum the kinds of tough standards they bring to the car-buying process. Over the last few years Consumer Reports has been interested in the stem cell treatment world and done some reporting that is worth reading.

A common question I hear is the following: is stem cell therapy covered by insurance? Unfortunately for patients desperate to try stem cells, insurance generally does not provide any coverage, which often leads them to take extreme financial measures. These steps can include fundraising (more below).

In my view, the Regenexx brand has made a big deal out of how some employers contribute towards costs of their clinics offerings. Im not so clear on where that stands today in 2020.

Does Medicare cover stem cell therapies? Medicare will generally cover the cost of established bone marrow transplantation type therapies. So stem cell transplant costs, which include hematopoietic stem cell transplant cost, are often zero for patients.

However it does not cover unproven stem cell therapies.

Patients are often reaching out to me so I know that many of them have gone to extraordinary measures to raise the money to pay to unproven stem cell clinics. Its painful to think about what little they get in return. Since we are by definition talking about unproven medical procedures here, in my view this money is largely down the drain.

If you have other data on stem cell economic issues such as what patients pay please let me know. Then theres the issue of what it actually costs the clinics per injection and in turn: whats their profit margin?

What ends up happening is that patients take out second mortgages on their houses, try to collect funds from friends and relatives, or turn to online fundraising. The internet fundraising efforts most often end up on GoFundMe. This is a trend Ive been noticing for years. Some colleagues even published a paper on this trend, a very interesting and an important read. The paper is Crowdfunding for Unproven Stem CellBased Interventions in JAMA by Jeremy Snyder,Leigh Turner , and Valorie A. Crooks. Heres a key passage:

As of December 3, 2017, our search identified 408 campaigns (GoFundMe=358; YouCaring=50) seeking donations for stem cell interventions advertised by 50 individual businesses. These campaigns requested $7439308 and received pledges for $1450011 from 13050 donors. The campaigns were shared 111044 times on social media. Two campaigns were duplicated across platforms but shared separately on social media. Of the 408 campaigns, 178 (43.6%) made statements that were definitive or certain about the interventions efficacy, 124 (30.4%) made statements optimistic or hopeful about efficacy, 63 (15.4%) made statements of both kinds, and 43 (10.5%) did not make efficacy claims. All mentions of risks (n=36) claimed the intervention had low/no risks compared with alternative treatments.

Supposedly GoFundMe has taken some steps to lower the often ethically thorny stem cell fundraising on its site, but Im not sure how much it has changed.

There is pressure on stem cell clinics now in 2022 in large part due to two factors. These could drive costs down or up depending on how things play out. First, the FDA is much more active against unproven stem cell clinics. This may mean more money from the clinics going toward paying attorneys or FDA compliance experts. Youd think this might drive costs up. However, the still large number of clinics may keep pressure to stay with keeping price tags lower.

The second factor is the COVID-19 pandemic, which has forced many clinics to stop injections temporarily. While a surprising number of clinicsI did by phone were still open in a small informal survey, others were in a holding pattern. This may lower supply which could raise prices. But I think demand is likely way down as many patients stay home to avoid COVID risks. This could be temporary though. As things start re-opening, as they are now, the clinics may be able to capitalize on pent-up demand.

To sum up, the answer to the question, How do stem cells cost? largely depends on context. Overall, clinics will charge what they think patients will pay them. It will always be a moving target. I urge patients to be cautious both medically, talking to their doctors, and financially.

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