Edmonton Sun | Canadian Blood Services holds third stem cell clinic - Edmonton Sun Edmonton Sun So many people have wanted to help find a stem cell match for an Edmonton boy fighting cancer that Canadian Blood Services hosted a third clinic. |
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A phase II stem cell treatment is the talk of the rheumatology community.
Stem cell treatments have been a topic of conversation among many people with autoimmune and degenerative forms of arthritis.
Now, an Australian pharmaceutical company is trying to figure out if this type of regenerative medicine could play a key role in treating or managing rheumatic diseases like rheumatoid arthritis (RA).
Mesoblast has developed a stem cell therapy that is administered intravenously to people with RA who didnt experience success taking anti-TNF drugs like Remicade, Enbrel, and Humira.
Read more: Stem cell therapy possible treatment for rheumatoid arthritis
The phase II study followed 48 patients who received one injection of the stem cell therapy.
These patients received therapeutic benefits as long as nine months after the initial dosing, company officials reported.
While more studies will be conducted in a phase III trial in order to validate the results, the results could mean positive things for the many people with RA who dont fare well on TNF-inhibitors.
Anti-TNF drugs are a billion dollar industry as well as a source of relief for many people with RA.
However, 20 to 40 percent of people treated with these medications either have an adverse reaction, or find no relief.
Perhaps the best news for people with RA who are sensitive to medications or experience pharmacophobia is that unlike some other treatments, little toxicity or side effects were indicated in the studies of Mesoblasts stem cell treatment.
Read more: Green tea for rheumatoid arthritis
The treatment uses mesenchymal precursor cells (MCPs).
Because the immune system doesnt recognize these MCPs as foreign or invaders, they dont tend to produce a negative response.
The MCP cells are adult stem cells, not embryonic stem cells.
The cells work because they contain certain receptors targeting the RA response and altering the way the bodys immune system works or, in the sense of RA, the way it malfunctions.
According to a published statement to the press from Mesoblast, The way the cells work is, they have receptors on their surface that are activated by every major cytokine that is important in progressive rheumatoid arthritis, including TNF, IL-1, IL-6, IL-17. Those cytokines drive the disease and also bind to receptors on our cells. And when they bind to our cells they activate the cells to release other factors that switch off the very cells that made those cytokines.
There continues to be more research done on stem cell therapy as a way to treat immune, autoimmune, and inflammatory diseases.
In the United States, a company called Regenexx shares some stem cell success stories on their website, often pertaining to healing osteoarthritis or injury.
While in the past, stem cells were only used to treat orthopedic injuries and conditions, newer research like the targeted regenerative stem cell therapy that is being created by Mesoblast also aims to treat other forms of arthritis like RA.
Read more: Biologic treatments for rheumatoid arthritis
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Regenerative Stem Cell Treatment Offers Hope for People with ... - Healthline
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Science Daily | Unproven stem cell 'therapy' blinds three patients at Florida clinic ... Science Daily Three people with macular degeneration were blinded after undergoing an unproven stem cell treatment that was touted as a clinical trial in 2015 at a clinic in ... Unethical Stem Cell Therapy for Autism In India? Regenerative Stem Cell Treatment Offers Hope for People with ... Autologous Cell Therapy Market Global Analysis & 2024 Forecast Research Report |
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David Sourdive, co-founder of Cellectis, discusses his pioneering work developing off-the-shelf CAR-T for cancer and the future directions of cell therapy.
Last week I had the opportunity to attend the World ADOPT Summit and hear from some of the world leaders in cell therapy. There I met David Sourdive, co-founder and VP of Cellectis, a French company that is leading the development of the first off-the-shelf CAR-T therapy.
CAR-T therapy consists in the infusion of T-cells engineered to better identify and kill cancer cells. The most advanced approaches, which could be approved as soon as by the end of this year, use an autologous approach by engineering cells from the own patient.Cellectis is taking the technology a step further and developing an allogeneic CAR-T therapy that uses cells from healthy donors instead.
Cellectis uses TALEN gene editing to develop off-the-shelf products that could make this miracle cancer therapy faster, cheaper and accessible to a wider patient population. Its first therapy, UCART19, now licensed to Servier and Pfizer, has shown striking results in two babies with leukemia. A second one, UCART123, recently received approval from the FDA to start clinical trials.
With his company positioned at the forefront of innovation in cell therapy, I decided to ask David Sourdive how he thinks new technologies will change the scene.
Cell therapy is now transitioning from the world of grafts, where it has been confined for decades, to the world of products. This happened with antibodies. People used to give their blood and antibodies. Then it became possible to manufacture antibodies from cells in an industrial setting, and then it became a product. I think that were going in that direction with cell therapy.
In the coming decade, off-the-shelf cell therapy will become a reality. That is a revolution and is going to change a lot of things. We will need to establish standards and regulations.Cells usually have not been regarded as products, so its a big leap. We have to discuss with regulators how to define the products.
The immune system is going to start being tweaked like it has never been and we will be able to take advantage of it to address very difficult diseases. For example, solid tumors.We think UCARTs can also target solid tumors. To that end, we work with two pharma partners that have strong capability to tackle these complicated tumors.
We are the first ones to do [allogeneic CAR-Ts] and theres no precedent. We have to invent everything. We have to figure out all the possibilities, all the solutions, and theres no real way to predict how things are going to behave in patients because historically, the one kind of cell nobody has ever used is an allogeneic unmatched situation is T-cells, by definition.
Its very exciting because every week we have to do something for the first time, its challenging.I think this year is the year when we will know better how allogeneic products behave in patients.
We have shown that gene editing can really be transformative in the CAR-T space. With gene editing, you can make the cells overcome the defense mechanisms of tumors. You can, for example, knock out genes such as PD1 so that CAR T-cells become capable of killing PDL1-bearing tumors.
Tumors that succeed in the body are tumors that have found a way to evade the immune system.You need to put additional features to empower the T-cells to do what normal T-cells fail to do. People will realize the transformative power of gene editing. We think it will take over the industry.
I think globally, gene editing is going to be a strong power because we are going to be able to tweak cells like weve never done before.We will be able to program cells to deliver a treatment locally. This is happening. Its not futuristic. Its now.
This is definitely going to be an exciting year, with the first CAR-T therapies approaching market approval and the first results from allogeneic CAR-Ts due soon. Keep tuned for the latest updates!
Images from Cellectis; Tyler Olson, ImageFlow /Shutterstock
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In the Coming Decade, Off-the-Shelf Cell Therapy will Become a ... - Labiotech.eu (blog)
SALT LAKE CITY Relief for chronic back and neck pain may be on the horizon, thanks to emerging science technology under development at the University of Utah.
Bioengineering researchers have discovered a technique to control chronic pain by regulating genes that reduce tissue- and cell-damaging inflammation.
This has applications for many inflammatory-driven diseases, said assistant professor Robby Bowles, who led the research. It could be applied for arthritis or to therapeutic cells that are being delivered to inflammatory environments that need to be protected from inflammation.
In laymens terms, the therapy has the potential to treat chronic pain by relieving swelling in affected areas and healing the tissue, he said.
For instance, chronic pain in slipped or herniated discs result from damaged tissue when swelling causes cells to create molecules that break down tissue, he explained. Inflammation is natures way of alerting the immune system to repair tissue or fight infection, but chronic inflammation can lead to tissue degeneration and pain, he said.
Bowles team uses the Clustered Regularly Interspaced Short Palindromic Repeat system known as CRISPR a new technology that modifies human genetics to halt cell death and keep cells from producing molecules that damage tissue and result in chronic pain, he said.
This is something that could be injected into your (damaged) discs to stop the signaling that is driving disc degeneration and the painful signaling, Bowles said. It would keep you from getting worse and it would stop the pain.
But Bowles said the therapy does not edit or replace genes, which is what CRISPR tools are typically used for. Instead, the therapy modulates the way genes turn on and off in order to protect cells from inflammation.
So they wont respond to inflammation. It disrupts this chronic inflammation pattern that leads to tissue degeneration and pain, he said. Were not changing what is in your genetic code. Were altering what is expressed. Normally, cells do this themselves, but we are taking engineering control over these cells to tell them what to turn on and turn off.
He said now that researchers know they can do this, doctors would be able to modify the genes using direct injection into the affected area which delays tissue degeneration. In the case of back pain, a patient may get a discectomy to remove part of a herniated disc to relieve the pain, but tissue near the spinal cord may continue to break down, leading to future pain, he said. This method could stave off additional surgeries by stopping the tissue damage, he noted.
The hope is that this stops degeneration in its tracks, and the patient could avoid any future surgeries, Bowles said. But its patient to patient. Some might still need surgery, but it could delay it.
So far, the team has developed a virus that can deliver the gene therapy and has filed for a patent on the system with the hope of moving to human trials after collecting initial data. One caveat Bowles noted was that there are currently no gene therapies approved for use by the U.S. Food and Drug Administration, so it may take some time to receive necessary acceptance.
So long term there are technological and regulatory hurdles to (overcome), he said. It could be about 10 years before this method is ready for use in patients.
Despite the regulatory issues, Bowles was optimistic about the long-range prospects for treating pain using this new therapy.
The CRISPR systems give us control that would allow us to begin treating these diseases in ways we couldnt treat them before, Bowles said. Over the next 10 to 15 years, were going to see a lot of these CRISPR technologies change these debilitating conditions.
The teams discovery was published in a new paper this month in a special issue of Tissue Engineering. The study was co-authored by University of Utah bioengineering doctoral student Niloofar Farhang and several other researchers in a collaborative project between the U., Duke University and Washington University in St. Louis.
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Thursday, March 16, 2017, 2:21 PM
Three elderly women afraid of losing their vision were blinded after having their own fat and blood cells injected into their eyes at a Miami stem cell clinic.
The patients incorrectly believed the treatment was part of a federally monitored clinical trial, but in reality received an injection that hasnt been proven effective nor tested for safety in people, CBS News reported.
Each of them had working vision aside from some blurriness prior to the procedure. After though, one of the women was left completely blind while the other two are now legally blind.
It seems unlikely their vision will improve, said ophthalmologist Dr. Thomas Albini, who examined the patients following their treatment. He and his colleagues described the outcome of the procedure in Thursdays New England Journal of Medicine.
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The group of women, in their 70s and 80s, in 2015 paid $5,000 to be treated for age-related macular degeneration one of the top causes of vision loss in people over the age of 50. At least two of the women showed up at the clinic because it specifically listed a macular degeneration study on a federal database, a listing the clinic later withdrew.
The consent form one woman showed Albini listed the treatment as a medical procedure rather than a study, the ophthalmologist told CBS.
Each of the patients were reportedly injected in both eyes with a mixture of cells derived from their own fat tissue.
Its very alarming to us as clinicians that somebody would do this to both eyes at the same time, Albini said, adding all three women suffered from detached retinas.
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Scientists have long studied similar procedures including taking stem cells from a patients body as a cure for vision problems, among other ailments and diseases.
Medical professionals and scientists have issued strong warnings against clinics doling out unproven stem cell treatments. Because these clinicians use the patients own stem cells, theyre minimally regulated by the Food and Drug Administration.
This report joins a small but growing medical literature highlighting the risks of such wanton misapplication of cellular therapy, stem cell expert Dr. George Daley wrote in an editorial accompanying a report on the procedure in question.
An attorney who represented two of the three women in lawsuits regarding the treatment said both cases have been resolved, but did not provide additional details.
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Three women suffering from a degenerative eye condition were blindedlikely permanentlyin a clinical trial for stem cell therapy, according to a report published Wednesday in the New England Journal of Medicine.
The women, who were all between the ages of 72 and 88, had a common medical condition called age-related macular degeneration, in which cells in the retina begin to die off, resulting in spotty or blurred vision. Researchers suspected stem cells derived from the patient's own body could regenerate some of the cells lost to the disease. So in the clinical trial, which was conducted in 2015, researchers removed some blood and fat from participants' anesthetized abdomens, treated the cells in a standardized way to make them revert to stem cells, then injected into their eyes. They were instructed to use an eyedrops antibiotic for a few days. The three patients had found the trial listed on the government web site clinicaltrials.gov, and had each paid $5,000 for the procedure. The informed consent form listed that blindness was possible as a result of the procedure.
MoreIt's Shockingly Easy To Buy Unregulated Stem Cell Treatments
A few days after the patients received the injected stem cells, the participants ended up in the hospital with vision loss, detached retinas, and hemorrhage. The patients lost vision; subsequent checkups led doctors to conclude that they would likely never regain their sight.
Despite the fact that the participants found the procedure on clinicaltrials.gov, the informed consent forms do not mention that it is in fact a clinical trial. "The patients paid for a procedure that had never been studied in a clinical trial, lacked sufficient safety data, and was performed in both eyes on the same day," the study authors write. Injecting something experimental into both eyes is both not safe and not typical, they continue.
Recently researchers have been testing lots of different medical uses for stem cells, from treating multiple sclerosis to spinal cord injuries. With the passage of the 21st Century Cures Act in December, Congress cleared the way for faster regulatory approval for promising treatments based on stem cells. At least 13 clinical trials were registered to treat AMD alone as of November 2016, the article authors write.
But anecdotes like these bolster those who counsel restraint when it comes to stem cells. "Although numerous stem-cell therapies for medical disorders are being investigated at research institutions with appropriate regulatory oversight, many stem-cell clinics are treating patients with little oversight and with no proof of efficacy," the article authors write.
Jeffrey Goldberg, a professor of ophthalmology at Stanford University and one of the authors of the article, calls this a "call to awareness for patients, physicians and regulatory agencies of the risks of this kind of minimally regulated, patient-funded research," according to a press release.
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Clinical Pain Advisor (registration) | Stem Cell Therapies for Degenerative Disc Disease Clinical Pain Advisor (registration) MSC therapy offers pain relief for patients with DDD and may slow the degenerative process of this condition. ORLANDOMesenchymal stem cell (MSC) therapy, also known as regenerative medicine therapy, is emerging as a promising treatment for ... |
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Each patient paid $5,000 for the procedure. Any clinical trial that has a fee should raise a red flag, the authors said.
Im not aware of any legitimate research, at least in ophthalmology, that is patient-funded, Albini said.
At the clinic, which is not named in the paper, the patients had fat cells removed from their abdomens and a standard blood draw. The fat tissue was processed with enzymes, with the goal of obtaining stem cells. Platelet-dense plasma was isolated from the blood. The cells were then mixed with the platelet-dense plasma and injected into their eyes. Patients reported that the entire process took less than an hour, Albini said. The patients had both eyes treated at once another red flag, Albini and Goldberg said, because most doctors would opt for a conservative approach to observe how one eye responds to an experimental treatment before attempting the other eye.
Shoddy stem cell preparation may have led to some of the patients complications, which could have been caused by injection of a contaminant or the cell wash solution into the eye, Albini said. When injected into the eye, the stem cells also could have changed into myofibroblasts, a type of cell associated with scarring.
But even if executed correctly, there is no evidence suggesting that the procedure could help restore vision, Goldberg and Albini said. In fact, there is sparse evidence that adipose-derived stem cells, the type of cells that the clinic claimed to use, are capable of differentiating, or maturing, into retinal pigment epithelium or photoreceptor cells, which play a critical role in macular degeneration and are the cells some researchers are targeting to develop therapies.
There is a lot of very well-founded evidence for the positive potential of stem therapy for many human diseases, but theres no excuse for not designing a trial properly and basing it on preclinical research, Goldberg said.
The trial lacked nearly all of the components of a properly designed clinical trial, including a hypothesis based on laboratory experiments, assignment of a control group and treatment group, collection of data, masking of clinical and patient groups, and plans for follow-up, Goldberg and Albini said. There was a whole list of egregious things, Albini said.
Listings on ClinicalTrials.gov are not fully scrutinized for scientific soundness, Goldberg said. Although still visible on the website, the listing now states: This study has been withdrawn prior to enrollment. The clinic is also no longer performing these eye injections, although it is still seeing patients, Albini said.
The procedures were arguably not subject to Food and Drug Administration approval because the cells were not transferred between patients and were considered minimally processed, according to Title 21, Part 1271.10, of the Code of Federal Regulations. The FDA released more specific guidelines in October 2015, after these procedures were performed, establishing the requirement for FDA oversight and approval for these types of procedures.
We expect health care providers to take every precaution to ensure patient safety, but this definitely shows that the lack of oversight can lead to bad players and bad outcomes. Its alarming, Albini said.
The authors acknowledged that it is difficult for patients to know whether a clinical trial, or a stem cell therapy, is legitimate. Goldberg recommended that patients considering a stem cell treatment consult a website, A Closer Look at Stem Cells, maintained by the International Society for Stem Cell Research. It is also advisable to check if a trial is affiliated with an academic medical center, Goldberg said.
The lead author is Ajay Kuriyan, MD, assistant professor of ophthalmology at the University of Rochester Medical Center. Researchers from the University of Miami, University of Rochester, University of Oklahoma and the Center for Sight also co-authored the study.
The report was funded by the National Institutes of Health (grant P30EY014801), Research to Prevent Blindness, the Department of Defense and the Klorfine Foundation.
Stanfords Department of Ophthalmology also supported the work.
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Unproven stem cell 'therapy' blinds three patients at Florida clinic - Stanford Medical Center Report