Category Archives: Stem Cell Therapy

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A cell and gene therapy accelerator formed by Mayo Clinic, Hibiscus BioVentures and Innoforce is officially up and running, the partners announced Wednesday.

Mayflower BioVentures will identify and launch companies around technologies that address unmet patient needs.

Mayo Clinic hasaccumulated a portfolio of next-generation immune system modulators as well as numerous novel therapeutics in cell and gene therapy. Now Mayo is sharing those discoveries and research capabilities in hopes of reaching patients.

We have the first right to look at the technologies that Mayo considered to be high-value opportunities, Chris Jeffers, CEO of Hibiscus BioTechnology, told BioSpace. Thats an internal designation. And we have the first rights to create companies from those.

It gives Hibiscus the opportunity to incubate and accelerate the companies within Mayflower anywhere between one and two years. Eventually our goal is to graduate those companies to be self-sufficient, independent companies that can obtain their own funding once they leave the accelerator, Jeffers added.

Andrew Danielsen, chair of Mayo Clinic Ventures, told BioSpace that each company will be within Mayflower and owned by the investor syndicate proportionally.

Mayflower has been in the works for at least a year, Jeffers and COO Sia Anaganostou shared, adding that they have been working with Mayo on identifying and developing several companies, which they expect to announce in the coming months.

While unable to provide further details, Jeffers said the areas of focus are anticipated to range from various types of stem cell therapies and gene therapies covering a number of conditions. Some of those technologies are ancillary to cellular therapies, while some are for new pathways to try to escape from traditional immuno-oncology, he said.

Mayflower will be run by the Hibiscus management team.

This is a big push from the Mayo Clinic to really increase its commercialization in this space. Were really proud to be associated with such a fantastic institution with unparalleled clinical expertise, Jeffers said, adding that these factors are a real differentiator.

Danielsen spoke of transitioning research from bench to bedside.

We believe this collaboration can bridge the gap between industry and innovative cell and gene therapy research, enabling emerging startups to navigate the challenges of producing meaningful, novel therapeutics that transform health and medicine, he said in a statement.

Mayos Center for Regenerative Biotherapeutics focuses on advancing regenerative technologies from discovery into early phase clinical studies.

Hibiscus is a venture capital firm focused on building patient-focused companies around new technology and helping to develop those discoveries into commercial drugs and therapies. Hibiscus is comprised of Hibiscus Biotechnology, a venture studio that works to build companies from scratch, and Hibiscus Capital Management, a VC firm that invests in promising early-stage biotech companies.

Innoforce is a partnership-focused biopharma company targeting advanced therapy medicinal products (ATMPs) and biologics. It offers contract development and manufacturing services including GMP manufacturing of plasmid DNA, RNA, viral vector and cell products.

Any revenue generated by Mayflower will go toward Mayo Clinics patient care, education and research.

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Mayflower BioVentures to Announce New Cell & Gene Therapy Companies within Months - BioSpace

Nes-Ziona, Israel, Sept. 06, 2022 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd.(Nasdaq: ENLV, the Company), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis and solid tumors, today announced that the U.S. Patent and Trademark Office issued a Notice of Allowance for patent application number 15/551,284. Once issued, the resulting patent will provide Enlivex with added intellectual property (IP) protection through at least 2036 with claims covering methods of using Allocetra to inhibit or reduce cytokine release syndrome in patients undergoing chimeric antigen receptor (CAR) T-cell therapy. The Company expects that this new patent will be issued in the United States by the end of the first quarter of 2023.

Oren Hershkovitz, PhD, CEO of Enlivex commented, We look forward to the anticipated issuance of this patent, which will broaden the robust IP portfolio protecting Allocetra and our various development programs. This IP portfolio is a key source of value for Enlivex, and we remain committed to its maintenance and continued expansion.

CAR T cells are T cells that have been genetically engineered to include a receptor that allows them to specifically target and destroy cancerous cells. While several CAR T cell treatments were recently approved by the FDA in several cancer indications, such treatments have been associated, in many patients, with a side effect named cytokine release syndrome, which describes a collection of potentially severe or life-threatening symptoms that stem from over-activation of immune pathways. Preclinical data indicate that Allocetra has the potential to prevent or reduce cytokine release syndrome associated with CAR T-cell therapies.

ABOUT ALLOCETRAAllocetra is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.

ABOUT ENLIVEX

Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra, a universal off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. For more information, visit http://www.enlivex.com.

Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as expects, plans, projects, will, may, anticipates, believes, should, would, could, intends, estimates, suggests, has the potential to and other words of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRATMprograms. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affectEnlivexsbusiness and prospects, including the risks thatEnlivexmay not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRATMproduct line could also be affected bya number ofother factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental,technologicaland other factors discussed inEnlivexsfilings with the Securities and Exchange Commission, including in the Companys most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.

ENLIVEX CONTACT Shachar Shlosberger, CFO Enlivex Therapeutics, Ltd. shachar@enlivexpharm.com

INVESTOR RELATIONS CONTACTEric RibnerLifeSci Advisorseric@lifesciadvisors.com

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Enlivex Receives Notice of Allowance for U.S. Patent Application Covering the Use of Allocetra to Prevent Cytokine Release Syndrome in Patients...

After a long period of no change in the treatment paradigm for leukemias, updates in our understanding of disease pathology and molecular targeting have changed the outlook for many patients. Both acute and chronic types of leukemia have undergone evolutions in treatment approaches that have offered better survival outcomes and more tolerable regimens.

All of the changes in leukemia therapy, and in fact, in most hematologic [malignancies], have been occurring at a dramatic rate over the last 5 to 10 years, Jeffrey R. Schriber, MD, said in an interview with Targeted OncologyTM.

Studying the underlying molecular factors associated with different types of leukemia, including acute myelocytic leukemia (AML), acute lymphocytic leukemia (ALL), chronic myelogenous leukemia (CML), and chronic lymphocytic leukemia (CLL), has enabled physicians to make more informed decisions on how aggressively to treat individuals with leukemia. This includes which targeted treatments can be employed and whether chemotherapy or hematopoietic stem cell transplant (HSCT) can be avoided.

Schriber, director of hematologic malignancies at Cancer Treatment Centers of America (CTCA) in Phoenix, Arizona, discussed the successes in the treatment landscape of leukemias and what challenges remain for oncologists.

Targeted OncologyTM: What are the most significant changes you have seen in the treatment of AML over the past 10 years?

SCHRIBER: Leukemia changed the most when we started to understand that there are molecular abnormalities present in some of these leukemias. We've known for a long time that FLT3 overexpression means a bad prognosis in AML and those patients don't do as well. We knew that allogeneic HSCT would work better for them. But what we didn't have is anything we could do about it. It was a little frustrating.

So investigators developed the FLT3 inhibitors. The first was midostaurin [Rydapt, Tauritmo]. There was a large randomized clinical trial [CALGB-10603; NCT00651261] where half of patients got it with standard chemotherapy, half of patients got [chemotherapy alone]. There was an impressive progression-free survival [PFS] and overall survival [OS] advantage to the group that received midostaurin.1 That was the first major change in leukemic therapy in over 20 years from an AML standpoint. Now, what you want to do immediately is test to see if the patient is FLT3 positive. If they are, midostaurin is added, or there are at least 2 other agents that target FLT3 as well.

But this recognition has led to other therapies. Now there is [ivosidenib; Tibsovo] for IDH1 mutations and [Enasidenib; Idhifa] for IDH2 mutations. We recognized that IDH1 and IDH2 carried the worst prognosis, and we now have inhibitors for both of those. The recognition that we have targeted therapies that can alter how we're treating the disease is probably the first huge thing that has happened [in this setting].

The average age of patients with AML is somewhere around 65 years. This type of therapy is pretty intense, and many of these patients, especially ones with FLT3-positive or harder diseases, would be looking at an allogeneic HSCT, and often they're very sick. Venetoclax [Venclexta] is an oral [inhibitor that] targets BCL-2. It has been used in combination with some of the agents that we commonly use that are well tolerated, like azacitidine [Vidaza], or decitabine [Dacogen]. Studies that are all 2 to 3 years old have shown even in these older patients who are not felt to be suitable for more aggressive therapy, that they are able to tolerate this and have an excellent complete remission rate.2,3 [Though it is oral], its still tough therapy. These patients drop [blood cell] counts and they can get sick. But that is a major advancement as well.

When I used to see patients with leukemia, I wanted to get them in, get their bone marrow [biopsy], make their diagnosis, know whether they had AML or ALL and [which] subtype, and I wanted to get them on therapy as soon as possible. That was always felt to be the mantra. But 2 years ago, there was a study done on the German Study Alliance LeukemiaAcute Myeloid Leukemia registry that showed that you don't have to do it right away, and if you wait and see if they're FLT3-, IDH1-, or IDH2-positive, you can tailor your therapy.4 That was another big thing that gave us a little sense of relief because we [learned] we don't have to [give treatment] right this second.

What improvements have been made in the treatment of ALL?

ALL is a disease that's much less common in adults. In adults, 80% of patients with leukemia have AML and maybe 20% or 30% have ALL. For children it's reversed. Children do very well with ALL, because [most patients] go on studies where they intensify the regimens. Those regimens can be very tough for some of the older adults to manage. But there's been a bit of a shift for adult patients under the age of 50. Its not the majority of adults with ALL, but in those patients, we've shifted towards a [pediatric-inspired] regimen. And if they can tolerate it, [patients receiving] those regimens seem to do a little bit better.5

In ALL, we usually see if patients are Philadelphia positive or Philadelphia negative. The Philadelphia chromosome is a translocation between chromosomes 9 and 22. It can cause CML, but it is also classic for ALL. They have a slightly different version of the genetic information that gets exchanged. Tyrosine kinase inhibitor [TKI] therapy blocks the tyrosine kinase that is responsible for this problem. For years, we've used those medicines to treat adults. But recently, there were data that as we get better TKIs, we may no longer have to give HSCT for all those patients.6 That became quite relevant in the COVID-19 era when we didn't want to take a patient through an allogeneic HSCT. One of the challenges we face is how do we know who [needs HSCT], because it is very effective, but its a tough thing to do. Are there patients we can cure? Traditionally, with Philadelphia-positive ALL, we always want to transplant. Recent data from The University of Texas MD Anderson Cancer Center group have shown with a better TKI, you may be able to avoid doing HSCT.7

We now use molecular testing [for minimal residual disease (MRD)] in both AML and ALL to determine whether there is still evidence of disease at very minute amounts. We've done this for years in CML.8 Being able to find minute amounts of disease is become very important because if we are able to get patients to these molecular responses with the regular therapies, they may not need an HSCT. It appears that some of these patients do just as well. The ability to [avoid] this very toxic therapy that is expensive and keeps patients in the hospital is a big advancement as well.

We now know in ALL that a patient may get into remission but they haven't achieved a molecular response. Molecular testing allows us to have a better 'camera' that gets a view of everything and says we may be able to avoid more intensive regimens for patients who are MRD negative. For patients who are MRD positive, there's a new medicine called blinatumomab [Blincyto], which is a bispecific T-cell engager. It takes CD19, a marker on ALL, and brings it together with the effector T cells. We can take patients who are molecularly positive and shift them to molecularly negative.9

Chimeric antigen receptor [CAR] T cells have changed what we do, particularly in young patients with ALL. I remember the first patient I had who I treated for relapsed leukemia [who received CAR T-cell therapy]. I had given her an allogeneic HSCT, and she did well for a period of time, but came back somewhere about 6 or 7 months after and that's usually a death sentence. At the time, there was a clinical trial of CAR T-cell therapy being done at The University of Texas MD Anderson Cancer Center. She did great for 2 years, and that was unheard of. The changes weve seen in ALL, particularly for CAR T, has been very gratifying. We can salvage patients that we couldn't have [before]. A lot of these patients are children because that's where the disease is more common.

The problem with CAR T cells is we're seeing failures now because we [are able to] follow up with patients. I think ALL is a little bit different, but in the lymphomas, [where we thought] this is going to cure patients, it's starting to come back, and we're seeing the same thing happening with multiple myeloma. The duration of this will be important to see whether we are going to continue [using] allogeneic HSCT. You can cure patients [with allogeneic HSCT], but it's tough therapy so we would like to have a replacement for if it's at all possible.

Have there been any recent changes in targeted therapy for CML?

In CML, we are building on [past efforts]. We have a brand-new medication for CML called asciminib [Scemblix], that targets different areas. In CML with the t(9;22) translocation, most TKIs target tyrosine kinases in one area, while this one targets the other. So in those rare patients that failed [other TKIs], this drug is more effective than some of the other drugs that we [compared it with] in a large randomized trial.10 So now we have a whole new target that we can go after. We usually think CML is an easy disease to deal with, and now we have something for when it [is harder to treat].

What are the most important new approaches to treating CLL?

CLL is the most common type of leukemia. Chronic leukemias usually go for many years, whereas the acute leukemias are the ones we need to treat right away. There are still many patients with CLL who we don't have to treat. Weve been able to identify biomarkers such as TP53, [which shows the disease will] be more aggressive. We look to see if patients have a mutation in the immunoglobulin gene, [which has] a favorable prognosis.

The biggest change has been the shift from chemotherapy, which we used to do 10 years ago, to immunotherapy. We have 2 different options. Venetoclax can be used with an antibody therapy and is very effective, but it can knock the [blood cell] counts down a little which makes patients sick. With COVID-19, we had to be careful about that.

The other set of agents are Bruton tyrosine kinase [BTK] inhibitors. BTKs are involved in how [malignant] cells are generated and proliferate. There are a variety of BTK inhibitors that have been effective, and they are now used up front in many patients. They were getting therapy with either ibrutinib [Imbruvica] or acalabrutinib [Calquence], and now there is a new one, zanubrutinib [Brukinsa].

[Due to these regimens], patients with CLL no longer get chemotherapy. What I think we will see soon is the combination of [venetoclax and BTK inhibitors] together, and we may even start talking about CLL as something that's going to stay away for a long period of time. Maybe we can talk about curing CLL down the road.

What are the most significant unmet needs in these types of leukemia?

The hardest thing is, what happens when the patients have failed therapies? That's where we spend a lot of our energy, and lot of the dollars in healthcare go towards that. We still need to be able to adjust quickly and [discover] how we can combine as many of these drugs as possible to get our best shot up front. That has been very hard because the way clinical trials work, for the most part, is you test 1 drug. What frustrates us sometimes is you can't do the study that you'd like to do. For instance, in CLL, we have [at least] 3 different drugs, and it would be nice to know that one is better than the other.

I think that's been tough because we can never move fast enough for [relapsed patients]. Weve made tremendous progress, but we still don't understand why some patients blow through regimens, and that is frustrating. The FLT3 [inhibitor] is standard; I think in time we will say, We used the IDH1 and IDH2 inhibitors; are there other therapies we can use? It's starting to happen, but it's not as well defined as I think it needs to be.

What is the most important piece of advice you would give to someone who is less familiar with recent developments in leukemia treatment?

My advice is to go to a center that [treats leukemia] a lot. One of the reasons I came to CTCA was to start a hematologic malignancies program, because like the changes I've talked about for leukemia, there are similar changes in lymphoma, in Hodgkin disease, and multiple myeloma. [Treatment for] these diseases continue to change on an ongoing basis, and it's hard to keep up.

If you're a general oncologist who mostly sees breast cancer, lung cancer, colon cancer, etc, its important to have someone who is an expert in immunological disorders. Go spend time at your center of excellence and learn the new therapies and the principles because the drugs will change. I would think about going to a center that does this. That's the way you learn. If I were a patient, I would want to go to a place where this is what they do primarily.

References:

1. Stone RM, Mandrekar SJ, Sanford BL, et al. Midostaurin plus chemotherapy for acute myeloid leukemia with a flt3 mutation.N Engl J Med. 2017;377(5):454-464. doi:10.1056/NEJMoa1614359

2. DiNardo CD, Jonas BA, Pullarkat V, et al. Azacitidine and venetoclax in previously untreated acute myeloid leukemia.N Engl J Med. 2020;383(7):617-629. doi:10.1056/NEJMoa2012971

3. Maiti A, Qiao W, Sasaki K, et al. Venetoclax with decitabine vs intensive chemotherapy in acute myeloid leukemia: A propensity score matched analysis stratified by risk of treatment-related mortality.Am J Hematol. 2021;96(3):282-291. doi:10.1002/ajh.26061

4. Rllig C, Kramer M, Schliemann C, et al. Does time from diagnosis to treatment affect the prognosis of patients with newly diagnosed acute myeloid leukemia?.Blood. 2020;136(7):823-830. doi:10.1182/blood.2019004583

5. Stock W, Luger SM, Advani AS, et al. A pediatric regimen for older adolescents and young adults with acute lymphoblastic leukemia: results of CALGB 10403. Blood. 2019;133(14):1548-1559. doi:10.1182/blood-2018-10-881961

6. Short NJ, Kantarjian HM, Ravandi F, et al. Long-term safety and efficacy of hyper-CVAD plus ponatinib as frontline therapy for adults with Philadelphia chromosome-positive acute lymphoblastic leukemia. Blood. 2019;134(suppl 1):283. doi:10.1182/blood-2019-125146

7. Short NJ, Kantarjian HM, Konopleva M, et al. Combination of ponatinib and blinatumomab in Philadelphia chromosome-positive acute lymphoblastic leukemia: Early results from a phase II study. J Clin Oncol. 2021;39(suppl_15):7001. doi: 10.1200/JCO.2021.39.15_suppl.7001

8. Branford S, Cross NC, Hochhaus A, et al. Rationale for the recommendations for harmonizing current methodology for detecting BCR-ABL transcripts in patients with chronic myeloid leukaemia.Leukemia. 2006;20(11):1925-1930. doi:10.1038/sj.leu.2404388

9. Franquiz MJ, Short NJ. Blinatumomab for the treatment of adult b-cell acute lymphoblastic leukemia: toward a new era of targeted immunotherapy.Biologics. 2020;14:23-34. Published 2020 Feb 14. doi:10.2147/BTT.S202746

10. Ra D, Mauro MJ, Boquimpani C, et al. A phase 3, open-label, randomized study of asciminib, a STAMP inhibitor, vs bosutinib in CML after 2 or more prior TKIs.Blood. 2021;138(21):2031-2041. doi:10.1182/blood.2020009984

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Leukemia Awareness Month: Improving Outcomes Over the Past Decade - Targeted Oncology

"Stem cells have enormous potential for alleviating suffering for many diseases which currently have no effective therapy. The field has progressed to the clinic and it is important that this pathway is underpinned by excellent science and rigorous standards of clinical research. The journal provides an important avenue of publication in translational aspects of stem cell therapy spanning preclinical studies, clinical research and commercialization."

Timothy O'Brien,Editor-in-Chief,Stem Cell Research & Therapy

"The study of stem cells is one of the most exciting areas of contemporary biomedical research. We believe that Stem Cell Research & Therapy will act as a highly active forum for both basic and translational research into stem cell biology and therapies. Specifically, by developing this forum for cutting edge research, we hope that Stem Cell Research & Therapy will play a significant role in bringing together the critical information to synergize stem cell science with stem cell therapies."

Rocky S Tuan,Editor-in-Chief,Stem Cell Research & Therapy

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Stem Cell Research & Therapy | Home page

Few of us know what they are or exactly how they work. But many of us have heard about the healing powers of stem cells, as well as the controversy surrounding them. Stem cells are well-debated and highly complex with promises ranging from fixing damaged knees to regenerating receding hairlines.

Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services.Policy

But what are stem cells? And, whats all the fuss all about?

Director of the Center for Regenerative Medicine and Surgery, Amy Lightner, MD, shares the differences between stem cell types, how stem cells can be used and when to be cautious of claims that might be too good to be true.

When most of us think of stem cells, we probably recall images of Dolly the cloned sheep. While its true that Dolly was born of stem cells, her place in science history is just one of many advancements in the field.

In fact, there are many different types of stem cells, each of which has different responsibilities and abilities. What unifies them is their ability to regenerate into new cells.

Regenerative medicine is an emerging field that uses innovative treatments to help regenerate or heal cell function thats lost due to aging, disease or injury, Dr. Lightner explains. The way we achieve this is by using stem cells in large quantities, targeted to a certain area, that the body uses to promote healing.

Adult stem cells are the only type of stem cells that are currently approved for medical use in the United States by the U.S. Food and Drug Administration (FDA). The term adult stem cells is a little confusing because theyre actually found in infants, children and adults. These cells live in a variety of tissue in our bodies including bone marrow, muscles, your brain, your intestines and more.

Think of adult stem cells as a little army of cells that can regenerate themselves into new cells to maintain and repair the tissue or muscle where theyre found. The catch with adult stem cells is that they cant become different types of cells (for example, blood stem cells can only become new blood cells, not skin or brain cells).

Unlike adult stem cells, embryonic stem cells have many more possibilities. Harvested during an embryos blastocyst stage (about five or six days after an embryo has been fertilized in a lab), embryonic stem cells have the potential to become any type of cell (called pluripotent cells). For these reasons, embryonic stem cells are the type of stem cells that generate the controversy most people associate with the topic.

Stem cell therapy has been around since the 1970s, when the first adult bone marrow cells were used to treat blood disease. A bone marrow transplant allows a recipient whose bone marrow cells have been damaged by chemotherapy or disease to receive healthy bone marrow stem cells from a donor.

Those stem cells have the potential to mature within the blood system into different immune cells that recognize and fight off different types of blood cancer. And they also have the ability to heal, says Betty Hamilton, MD, Department of Hematology and Medical Oncology.

Bone marrow transplants are currently used to treat diseases including:

While you may have heard about the use of stem cell therapy for knees, back pain, arthritis, hair loss, diabetes and more, no other types of stem cell therapy beyond bone marrow transplants have yet been approved by the FDA. But thousands of clinical trials are available ranging from treatments for Crohns disease to multiple sclerosis and more. The common link between all these trials is the ability of the stem cells to reduce inflammation and repair damage to your body.

Dr. Hamilton and Dr. Lightner agree that were only just beginning to scratch the surface of stem cell therapy. In recent years, during the height of the COVID-19 pandemic, many clinical trials were underway to explore whether stem cells could be used to help treat the damaged lungs in people severely affected by the disease.

I think potential is the perfect word to describe stem cells, says Dr. Hamilton. We know they have these anti-inflammatory and regenerative properties where they can provide a significant improvement to someone suffering from a certain disease. There are so many diseases where inflammation happens, and something needs to be repaired, and so any help the immune system can get provides a lot of potential.

Scientists are also researching whether adult stem cells can turn into pluripotent stem cells, which would allow the cells to change into any cell type without involving the use of embryonic stem cells.

While the potential for stem cell therapy is great, doctors caution that were not quite there yet.

I always tell patients that ask about stem cell therapy clinics or traveling overseas for stem cell therapy treatment that if its not something that is a clinical trial with FDA oversight, then they have no real way of knowing whats being given to them, advises Dr. Lightner.

This means more harm can come than good if you dont know exactly whats being given to you. Or, in some cases, youre just spending thousands of dollars for what ends up being saline, Dr. Lightner says.

The best way to know that youre receiving sound medical treatment is to make sure the one youre considering is approved by the FDA on its Clinical Trials database.

Dr. Lightner cautions against treatments that sound too good to be true. While stem cell therapy has helped improve and save millions of lives, its best to know what exactly youre signing up for by seeking out a qualified medical provider offering an FDA-approved clinical trial.

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Stem Cell Therapy Is It Right for You? Cleveland Clinic

Researchers at Mayo Clinic's campus in Florida have conducted the world's first prospective, blinded and placebo-controlled clinical study to test the benefit of using bone marrow stem cells to reduce arthritic pain and disability in knees.

It is the first time that the belief that stem cells can provide substantial and possible regenerative relief in an ailing joint has been put to the test in such a rigorous fashion. The researchers say such testing is needed because there are at least 600 stem cell clinics in the U.S. offering one form of stem cell therapy or another to an estimated 100,000-plus patients, who pay thousands of dollars, out of pocket, for the treatment, which has not undergone demanding clinical study.

The findings in The American Journal of Sports Medicine represent another first patients not only had a dramatic improvement in the knee that received stem cells, but also in their other knee, which also had painful arthritis but received only a saline control injection. Each of the 25 patients enrolled in the study had two bad knees, but did not know which knee received the stem cells.

Given that the stem cell-treated knee was no better than the control-treated knee both were dramatically better than before the study began the researchers say the stem cells' effectiveness remains somewhat uninterpretable. They are only able to conclude the procedure is safe to undergo as an option for knee pain, but they cannot yet recommend it for routine arthritis care.

Our findings can be interrupted in ways that we now need to test one of which is that bone marrow stem cell injection in one ailing knee can relieve pain in both affected knees in a systemic or whole-body fashion, says the study's lead author, Shane A. Shapiro, M.D., a Mayo Clinic orthopedic physician.

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Mayo Clinic uses stem cell therapy to treat arthritis in knee